SARS-CoV-2

$21.6 Million Funds New York's Expanding Polio Investigations

Donald Hackett — Thu, 26 Jan 2023 21:26:49 +0000

Reviewer:

The New York State Department of Health (NYSDOH) recently announced new investments to expand the State's wastewater surveillance program, furthering New York's (NY) preparedness to combat the spread of infectious diseases.

Announced on January 23, 2023, the new $21.6 million funding includes a grant from the U.S. Centers for Disease Control and Prevention (CDC) alongside NY Governor Hochul's investments.

Established in August 2021 to support the State's COVID-19 pandemic response, NYSDOH's Wastewater Surveillance Network reaches all 62 NY counties.

It has proven integral to the advanced tracking of the SARS-CoV-2 coronavirus and, more recently, detecting poliovirus in certain areas in NY.

The new investment will increase the number of participating sewer sheds from 125 to over 215.

This will grow the Department's program to reach over 16 million New Yorkers, about 81% of the population served by public sewer systems.

"Since its inception, the Department's wastewater surveillance has been a key part of the State's most critical public health responses," Acting State Health Commissioner Dr. James McDonald said in a press release on January 23, 2023.

"Providing confidential, science-based, and community-level information, wastewater monitoring is advancing our tracking of trends for COVID-19 and has been invaluable in identifying polio in communities."

"These resources directly expand our wastewater monitoring network – and its reach – giving our team additional proactive capabilities to protect and promote the health of New Yorkers against more health threats."

Wastewater surveillance, a process by which sewage samples (containing feces flushed down the toilet) are collected from treatment plants and sent to laboratories for testing, can provide early detection for both symptomatic and asymptomatic virus cases in a community, serving as an essential indicator of disease burden within an area at any given time.

As of January 24, 2023, NYSDOH confirmed the presence of poliovirus in 100 positive samples of concern.

Poliovirus samples have been collected in Rockland County, Orange County, Sullivan County, Nassau County, Brooklyn (Kings County), and Queens County.

Previously, the U.S. Centers for Disease Control and Prevention (CDC) announced on November 30, 2022, it was expanding wastewater testing in the U.S. Michigan and Philadelphia are among the locations exploring plans to collect poliovirus wastewater samples.

And Dr. José R. Romero, Director of CDC's National Center for Immunization and Respiratory Diseases, indicated poliovirus testing would continue into early 2023.

Globally, poliovirus type 2 isolates have been identified in sewage samples collected in Canada, London, and Israel in 2022.

Sub Title:

Wastewater testing reaches 215 treatment plants

References:

NY Announces Wastewater Surveillance Expansion and Increased Disease Monitoring Capabilities

NY Dept. Health Wastewater Surveillance 2023

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Monday, February 6, 2023 - 12:15

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by U. Njglrk

Could Coronavirus Variants Evade Human Immune Systems

Don Hackett — Wed, 20 Oct 2021 12:08:51 +0000

Reviewer:

Robert Carlson, MD

With every new variant of the SARS-CoV-2 beta coronavirus that emerges to cause a surge in cases, a troubling question also arises: Could a new coronavirus eventually arrive with a set of mutations that would enable it to evade our immune response entirely?

A recent study published in the journal Nature on September 20, 2021, suggests that it will be hard for the virus to get there.

Studying dozens of naturally occurring and laboratory-selected mutations, these researchers found that a future SARS-CoV-2 virus variant will need to pack about twenty of the correct mutations to become fully resistant to the antibodies that an average person generates in response to a coronavirus infection or vaccination.

But even if the virus pulls off this genetic feat, it remains vulnerable to an improved set of antibodies.

The findings suggest that our immune system if adequately stimulated is capable of dealing with the worst that the coronavirus may have to offer for the foreseeable future.

‘Optimally elicited human polyclonal antibodies against SARS-CoV-2 should be resilient to substantial future SARS-CoV-2 variation and may confer protection against potential future sarbecovirus pandemics.’

“Immunity in people who fought off COVID last year and later received mRNA vaccines is impressively broad,” says Paul Bieniasz, head of the Laboratory of Retrovirology at Rockefeller University, in a press statement.

“This tells us that although natural infection or the vaccines lead to immunity, they have in no way come close to exhausting the capacity of the human immune system to mount a defense against this coronavirus.”

Just as the coronavirus comes in many variants, so do our antibodies.

That’s why even the Delta variant, the most contagious version of SARS-CoV-2 so far, doesn’t entirely escape our immune response. It may be dodging some of the antibodies we produce, but not all of them.

But Delta is not the last version of SARS-CoV-2 that we are going to see.

The virus is still replicating at a high rate in large populations—new mutations are popping up, and new variants are continuously arising.

Postdocs Fabian Schmidt and Yiska Weisblum set out to identify which kinds of mutations give SARS-CoV-2 the edge over antibodies.

For the study, they first created a safe stand-in for the coronavirus by tweaking a different, harmless virus to express SARS-CoV-2 spike protein on its surface. As the faux coronaviruses replicated, some picked up mutations as they made mistakes copying themselves.

The team then bathed the faux coronaviruses in plasma samples from people who had recovered from COVID-19 and selected the mutants that escaped neutralization by antibodies.

A few rounds of this and the team found many mutations in the exact locations as those occurring naturally in SARS-CoV-2 variants, including those found in Delta or other variants of concern.

The researchers then created a “polymutant” virus: a faux coronavirus sporting a spike protein featuring 20 of the worst of those mutations all at once.

This polymutant showed near-complete resistance to antibodies generated by individuals who have been infected by or vaccinated against SARS-CoV-2.

“So it is possible for the virus to evolve and evade the majority of our antibodies, but the genetic barrier to that occurring is quite high,” Bieniasz added.

Additionally, findings from one group of people suggest that our immune system will win the race against the mutating coronavirus in the long run.

People who have experienced both natural infection and vaccination produce remarkably effective antibodies.

Previously, the Rockefeller team that includes Michel Nussenzweig, Paul Bieniasz, and Theodora Hatziioannou, a research associate professor, found that after the infection subsides, antibodies continue to evolve over several months, becoming better at binding tighter to the spike protein.

And receiving COVID-19 vaccines strongly boosts those antibodies, even more, increasing them in numbers and improving their ability to cope with many variants simply by binding tighter and tighter to the original sequence.

In the current study, plasma from those infected and vaccinated neutralized the polymutant spike. It also neutralized the six SARS-CoV-2 variants tested and the original SARS-1 coronavirus and SARS-like viruses found in bats and pangolins.

“Antibodies from this group of people are incredibly potent and flexible,” says Hatziioannou, who co-directed the study.

“It’s likely that they offer protection against any SARS-CoV-2 variants in the future and possibly against future coronavirus pandemics.”

More studies would show whether booster shots could lead to a similar improvement of antibodies in vaccinated people who have never been infected with the coronavirus, concluded these researchers.

These researchers disclosed no industry conflicts of interest.

CoronavirusToday publishes fact-checked research-based vaccine news.

Sub Title:

Genetic barriers to SARS-CoV-2 virus polyclonal neutralizing antibody escape

References:

Could future coronavirus variants fully dodge our immune system?

High genetic barrier to SARS-CoV-2 polyclonal neutralizing antibody escape

Evolutionary origins of the SARS-CoV-2 sarbecovirus lineage responsible for the COVID-19 pandemic

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Wednesday, October 20, 2021 - 05:45

Japan’s Olympic Games May Flame-Out Again

Don Hackett — Sun, 23 May 2021 15:59:10 +0000

Reviewer:

Robert Carlson, MD

The Japan Times reported today a government spokesman discussed the possibility of extending the current State of Emergency in Tokyo, Osaka, and other prefectures beyond the May 31, 2021, expiration date.

As an example, Japan has placed the Okinawa Prefecture under the State of Emergency through June 20th. Okinawa confirmed a record high number of 231 COVID-19 cases on May 22nd.

Secretary Katsunobu Kato said on an NHK program 'the government will take into account the number of infections, the occupancy rates of hospital beds for COVID-19 patients and data concerning people’s movements when making decisions about lifting the emergencies in the 10 prefectures.'

Currently, in areas with a confirmed resurgence of SARS-CoV-2 virus infection, Japan's Health Ministry and prefectures are collaborating to implement focused and intensive PCR testing, requests to shorten business hours, etc.

As of May 21, 2021, Tokyo has confirmed the majority of COVID-19 cases, hospitalizations, and related fatalities.

With the Summer Paralympics and Olympics 2020 scheduled to launch on July 21, 2021, Japan's ongoing State of Emergency may require another extension. The already-delayed events are scheduled to be held across 42 competition venues across Japan.

If held as scheduled, Olympic participants would need to arrive in early July, to comply with Japan's two-week quarantine of international visitors.

As of May 19th, foreign nationals who have stayed in any of the following 159 countries/regions within 14 days prior to the application for landing are denied to enter Japan pursuant to Article 5, paragraph, item (xiv) of Immigration Control and Refugee Recognition Act, unless special exceptional circumstances are found.

The U.S. CDC announced on May 19, 2021, 'because of the current situation in Japan even fully vaccinated travelers may be at risk for getting and spreading COVID-19 variants and should avoid nonessential travel to Japan.'

This Level 3 Travel Alert says 'if you must travel to Japan, get fully vaccinated before travel. See the CDC recommendations for fully vaccinated travelers and unvaccinated travelers.’

To expand access to COVID-19 vaccines, Japan recently authorized its version of the Moderna COVID-19 vaccine.

And, ‘get tested with a viral test 1-3 days before your trip, says the CDC.

Furthermore, when returning to the USA, all air passengers, including U.S. citizens and fully vaccinated people, are required to have a negative COVID-19 test result no more than 3 days before travel or documentation of recovery from COVID-19 in the past 3 months before they board a flight to the USA.

Vax-Before-Travel publishes research-based travel vaccine news.

Sub Title:

Japan approves COVID-19 Vaccine Moderna Intramuscular Injection

References:

Border enforcement measures to prevent the spread of novel coronavirus (COVID-19)

Top Japan government spokesman floats COVID-19 emergency extension

Tokyo Olympics 2021

COVID-19 Information and Resources

CDC: Travel Recommendations for Fully Vaccinated Travelers

CDC: Information for people who recently recovered from COVID-19

COVID-19 Vaccine Moderna Intramuscular Injection (TAK-919)

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Immunocompromised Pediatric Patients Showed T-cell Activity and Humoral Immunity Against SARS-CoV-2

Don Hackett — Thu, 13 May 2021 17:42:25 +0000

Reviewer:

Robert Carlson, MD

According to data from a recent study of adult and pediatric patients with antibody deficiencies, patients that often fail to make protective immune responses to infections and vaccinations showed robust T-cell activity and humoral immunity against SARS-CoV-2 structural proteins.

The new study published on May 13, 2021, led by researchers at Children’s National Hospital, is the first to demonstrate a robust T-cell response against SARS-CoV-2 in immunocompromised patients.

The study, published in the Journal of Clinical Immunology, showed that patients with antibody deficiency disorders, including inborn errors of immunity (IEI) and common variable immunodeficiency (CVID), can mount an immune response to SARS-CoV-2.

The findings propose that COVID-19 vaccination may still be helpful for this population, said these researchers.

“If T-cell responses to SARS-CoV-2 are indeed protective, then it could suggest that adoptive T-cell immunotherapy might benefit more profoundly immunocompromised patients,” stated Michael Keller, M.D., director of the Translational Research Laboratory in the Program for Cell Enhancement and Technologies for Immunotherapy at Children’s National, located in Washington DC, in a related press statement.

“Through our developing phase I study T-cell immunotherapy protocol, we intend to investigate if coronavirus-specific T-cells may be protective following bone marrow transplantation, as well as in other immunodeficient populations.”

“This data suggests that many patients with antibody deficiency should be capable of responding to COVID-19 vaccines, and current studies at the National Institutes of Health and elsewhere are addressing whether those responses are likely to be protective and lasting,” added Dr. Keller.

The T-cell responses in all the COVID-19 patients were similar in magnitude to healthy adult and pediatric convalescent participants.

Currently, there is very little data on adaptive immune responses to SARS-CoV-2 in these vulnerable populations.

The study sheds light on the antibody and T-cell responses to SARS-CoV-2 protein spikes based on a sample size of six patients, including a family group of three children and their mother. All have antibody deficiencies and developed mild COVID-19 symptoms, minus one child who remained asymptomatic.

Control participants were the father of the same family, who tested positive for COVID-19, and another incidental adult (not next of kin) experienced mild COVID-19 symptoms. The researchers took blood samples to test the T-cell response in cell cultures and provided comprehensive statistical analysis of the adaptive immune responses.

“This was a small group of patients, but given the high proportion of responses, it does suggest that many of our antibody deficient patients are likely to mount immune responses to SARS-CoV-2.”

“Additional studies are needed to know whether other patients with primary immunodeficiency develop immunity following COVID-19 infection and will likely be answered by a large international collaboration organized by our collaborators at the Garvan Institute in Sydney,” concluded Dr. Keller.

Previously, anticipating an expanded use authorization by the U.S. Food and Drug Administration (FDA), Children’s National Hospital established a waitlist for children ages 12 and up on May 5, 2021. The FDA announced the expanded authorization on May 10th.

Children’s National Hospital has vaccinated close to 4,000 adolescents since December 2020. Children’s National Hospital celebrates 150 years of pediatric care, research, and commitment to the community.

PrecisionVaccinations publishes research-based vaccine news.

Sub Title:

Patients with antibody deficiency showed antibody and T cell responses to SARS-CoV-2

References:

Robust Antibody and T Cell Responses to SARS-CoV-2 in Patients with Antibody Deficiency

Coronavirus disease 2019 in patients with inborn errors of immunity: An international study

Children’s National opens vaccine waitlist for children 12 and up in anticipation of Pfizer authorization

U.S. FDA Authorizes mRNA COVID-19 Vaccine for Adolescents

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Thursday, May 13, 2021 - 16:15

US Funds $250 Million to Create New Vaccination Workforce

Don Hackett — Mon, 10 May 2021 19:12:05 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

The U.S. Department of Health and Human Services (HHS) recently announced the availability of approximately $250 million to develop and support a community-based vaccination workforce.

Announced on May 4, 2021, this new workforce will serve as trusted voices sharing information about vaccines, increase COVID-19 vaccine confidence, and address any barriers to vaccination for individuals living in vulnerable and medically underserved communities.

According to HHS, this funding will help community-based organizations to hire and mobilize community outreach workers, community health workers, social support specialists, and others to conduct on-the-ground outreach to educate and assist individuals in getting the information they need about vaccination, help make vaccine appointments, and assist with transportation needs.

“Increasing public confidence in COVID-19 vaccines and boosting uptake remains a critical part of our fight against this virus,” commented HHS Secretary Xavier Becerra in a press statement.

“Today’s funding is critically important for connecting vulnerable and underserved communities with trusted health voices who can help deliver vaccinations and information to keep them safe and protect their loved ones.”

Previously, HHS had established the Federal Retail Pharmacy Program for COVID-19 Vaccination, a collaboration between the federal government, states and territories, and 21 national pharmacy partners and thousands of independent pharmacies to increase access to COVID-19 vaccination across the USA.

The Federal Retail Pharmacy Program is designed to leverage the strength and expertise of pharmacy partners to help rapidly vaccinate the American public.

As a result, about 90% of Americans have vaccine access through a community pharmacy within five miles of where they live – including in some of the nation’s hardest-hit and highest-risk communities.

“The Health Resources and Services Administration (HRSA) is uniquely suited to oversee this effort because of its long-standing mission and programs that work every day to improve health care to people who are geographically isolated, economically or medically vulnerable,” said Acting HRSA Administrator Diana Espinosa.

“Through HRSA’s Community-Based Workforce for COVID-19 Vaccine Outreach Program, recipients will partner with community organizations to serve populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.”

Approximately ten award recipients will be funded by the $250 million funding to engage with multiple organizations regionally and locally, including with community-based organizations, health centers, minority-serving institutions, and other health and social service entities.

Currently, the U.S. FDA has Authorized three COVID-19 vaccines.

On May 10, 2021, the U.S. CDC reported 114,375,695 people over 18 years of age had been fully vaccinated against COVID-19. This data represents about 44.3% of the US population.

The second funding opportunity will be released shortly and will focus on smaller community-based organizations.

To apply for the Community-Based Workforce for COVID-19 Vaccine Outreach Program Notice of Funding Opportunity, visit Grants.gov. Applications are due May 18, 2021. HHS Frequently Asked Questions are published on this webpage. HHS is located at 200 Independence Avenue, S.W., Washington, D.C. 20201.

PrecisionVaccinations publishes research-based vaccine news.

Sub Title:

Community based workforce established for COVID-19 vaccine outreach program

References:

HHS Announces $250 Million from American Rescue Plan to Develop and Support a Community-Based Workforce to Increase COVID-19 Vac

CDC: Federal Retail Pharmacy Program

COVID-19 Vaccines in the USA

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Monday, May 10, 2021 - 20:15

Cruise Ship Industry Launches ‘Dry-Run’ Voyages

Don Hackett — Sat, 08 May 2021 17:43:11 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

The US Centers for Disease Control and Prevention (CDC) released updated guidance for the international cruise industry to return to US waters.

On May 7, 2021, the CDC suggests cruise ships undertake simulated voyages with volunteer passengers as part of its COVID-19 Conditional Sailing Certificate (CSO) application.

The CDC stated it ‘is committed to working with the cruise industry and seaport partners to resume cruising following the phased approach outlined in the CSO. This goal aligns with the prospective resumption of passenger operations in the USA by mid-summer, expressed by many major cruise ship operators and travelers.’

With the issuance of these CDC technical instructions, cruise ship operators now have all the requirements and recommendations they need to start simulated voyages before resuming restricted passenger voyages.

CDC released the CSO in October 2020 to prevent the further spread of COVID-19 on cruise ships, from cruise ships into communities, and to protect public health and safety. The Order introduced a phased approach for the resumption of passenger cruises to mitigate the risk of spreading COVID-19 onboard.

In the final phase of the CSO, cruise ship operators with an approved COVID-19 CSO application will be permitted to sail with passengers following the requirements of the CSO.

The CDC says, ‘COVID-19 vaccines play a critical role in the safe resumption of passenger operations, but not all cruise ship operators have announced plans to mandate passenger vaccinations.’

‘As more people are fully vaccinated, and more drug therapeutics are available, the phased approach allowed CDC to incorporate these advancements into planning for safe resumption of cruise ship travel.’

The ‘CDC recommends that all port personnel and travelers (passengers and crew) get a COVID-19 vaccine when a vaccine is available to them.’

As of May 8, 2021, the CDC has issued emergency authorization for three experimental COVID-19 vaccines.

The CDC acknowledges that it is impossible for cruising to be a zero-risk activity for the spread of the SARS-CoV-2 virus that causes COVID-19. While cruising will always pose some risk of virus transmission, the CDC is committed to ensuring that cruise ship passenger operations are conducted in a way that protects crew members, passengers, and port personnel.

Furthermore, the CDC will continue to update its guidance and recommendations to specify basic safety standards and public health interventions based on the best scientific evidence available. For more information about COVID-19 and cruise ships, please visit What CDC is Doing for Cruise Travelers and Cruise Ship Guidance.

Vax-Before-Travel publishes research-based travel vaccine news.

Sub Title:

Cruise ships to undertake simulated voyages with volunteer passengers in US waters

References:

CDC Issues Phases 2B and 3 of the Conditional Sailing Order

Technical Instructions for Simulated Voyages

COVID-19 Vaccines in the USA

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Sunday, May 9, 2021 - 07:15

Alaska Cruise Season Sets Sail From Juneau

Don Hackett — Wed, 05 May 2021 21:05:53 +0000

Reviewer:

Robert Carlson, MD

UnCruise Adventures announced it intends to make a significant comeback relaunching in Alaska earlier than expected due to high consumer demand.

UnCruise Adventures confirmed on May 3, 2021, three Pacific Northwest sailings will take place after Washington State COVID-19 protocols affected the scheduled departure dates.

In place of a cancellation, the company saved the long-awaited adventure cruises of dozens of guests offering them an alternative itinerary out of Juneau, Alaska, covering guest airfares and hotels to ensure an unforgettable experience.

The company’s CEO Captain Dan Blanchard announced he will also lead history walks through Juneau prior to each embarkation.

“When recent changes were made affecting our Seattle departures, I knew I could not disappoint our guests with another cancellation. Some of our guests have been waiting on this cruise for two or three years,” shared Blanchard in a press release.

“It makes me proud to see my team jump into action and ready to do what it takes to make this year one of the biggest comebacks we’ve ever had.”

On May 7, 2021, UnCruise will kick off the company’s first full Alaska season that includes six adventure itineraries of 22-86 guests, led by a fully vaccinated crew. The company’s recent policy change requires all guests to provide proof of vaccination to embark on their adventure to the Great Land.

UnCruise Adventures emerged from the COVID-19 pandemic as a leader in the cruise industry and continues to work with local, state, and national officials to progress travel initiatives.

Commenting on his company’s 2021 return, Captain Blanchard stated, “After a challenging year, we continue to win the trust of our partners and guests with our safety-first policies and our commitment to the return of a strong and healthy cruise industry.”

“We understand the importance of cruise lines in the Alaska economy and a return to sailing to the future of my company,” shares Blanchard. “Vaccinations are on the rise and data has shown that Alaska has outperformed other states during the pandemic.”

“There is hope on the horizon, and Alaska is wide open for us this season!”

UnCruise Adventures summer Alaska season will include departures from Juneau, Sitka, and Ketchikan, and with the fully vaccinated crew and guests.

The company’s updated vaccine policy and travel resources can be found on the website uncruise.com.

The state of Alaska posts updated COVID-19 information on this webpage.

This webpage contains information and advisories for travelers, as well as links to community-specific travel restrictions, and information about arriving via the Alaska Ferry or road.

Beginning June 1, 2021, at participating airports, all travelers to Alaska will be eligible to receive a free COVID-19 vaccine. The State of Alaska has no special entry or travel testing requirements.

Vax-Before-Travel publishes travel vaccine news.

Sub Title:

UnCruise Adventures confirmed Pacific Northwest cruise sailings will launch

References:

UnCruise Adventures Cruise Comeback for 2021 Starts Alaska Earlier Than Expected Due to Big Demand

State of Alaska COVID-19 Information

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Wednesday, May 5, 2021 - 15:15

Resuming International Travel Faces Starts & Stops

Don Hackett — Sat, 01 May 2021 14:40:36 +0000

Reviewer:

Robert Carlson, MD

With summer 2021 quickly approaching in the Northern Hemisphere and COVID-19 vaccination rates increasing, many people are eager to resume international travel.

Additionally, many countries are loosening restrictions to welcome visitors once again.

However, international travel poses health risks, and even fully vaccinated travelers are at increased risk for getting and possibly spreading COVID-19 variants. Since the COVID-19 pandemic differs from country to country, prospective travelers should pay close attention to the situation at their destination.

On April 19, 2021, the U.S. Department of State issued Travel Advisories resulting in a significant increase in the number of countries classified as “Level 4: Do Not Travel.” These travel advisories are found on this webpage.

Within the USA, the Centers for Disease Control and Prevention (CDC) says, ‘Once you are fully vaccinated, you can travel safely between states.’

The CDC recommends delaying travel until you are fully vaccinated because travel increases your chance of getting and spreading COVID-19. The CDC has authorized three experimental COVID-19 vaccines, which are offered in most pharmacies.

Besides COVID-19, there are several disease outbreaks worldwide, such as polio, measles, dengue, and yellow fever. Suggested vaccines are listed on this webpage.

If you are not fully vaccinated against these diseases and must travel, you should visit a healthcare provider specializing in travel vaccinations prior to departure.

To find a vaccine provider near you, visit the Vaccine Finder or your state or local public health department website.

Furthermore, the State Department suggests enrolling in the Smart Traveler Enrollment Program (STEP) to receive timely Alerts about evolving health and safety conditions in your future destination.

Vax-Before-Travel publishes research-based travel vaccine news.

Sub Title:

Level 4 Travel Advisories issued for most countries

References:

US Department of State: Travel Advisory Updates

Smart Traveler Enrollment Program

Travel Vaccines

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Sunday, May 2, 2021 - 05:45

Japan Issues Third State of Emergency: Closes Down Travel

Don Hackett — Tue, 27 Apr 2021 20:02:53 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The US Embassy in Japan confirmed a ‘Third State of Emergency’ notice was issued. This declaration became effective on April 25, 2021.

This new declaration is scheduled to terminate on May 11, 2021, but could be extended further, similar to previous states of emergency.

The Government of Japan has reimposed a state of emergency for Tokyo, Osaka, Hyogo, and Kyoto prefectures and urge residents to take all possible precautions against the spread of COVID-19.

On April 26, 2021, the U.S. CDC issued a Level 3 Travel Alert, saying ‘Travelers should avoid all nonessential travel to Japan.’

Under the current state of emergency, bars and restaurants serving alcohol, most department stores, amusement parks, and other recreation facilities are requested to close temporarily. In addition, some public transportation providers are asked to reduce service on weekends and holidays.

Several prefectural governments continue to ask citizens to refrain from traveling to/from locations where the state of emergency is affected. There may be other closure requests and COVID-19 mitigation measures put into place in these prefectures.

Furthermore, all air travelers to the USA must show a negative COVID-19 test taken within three days before boarding their flight. U.S. citizens are subject to this rule. U.S. military and SOFA status travelers should consult with their commands on their travel requirements and possible exceptions.

Being fully vaccinated for COVID-19 does not exempt any traveler from the requirement to receive a negative PCR test no more than three days before boarding a flight to the USA.

The Government of Japan continues to enforce strict travel regulations that bar most new foreigners from entering Japan. Foreign tourists and non-resident foreign business travelers remain prohibited from entering Japan.

Japanese citizens and foreign residents with a permit are generally allowed to reenter Japan but must comply with strict pre-and post-travel testing requirements and self-quarantine upon arrival.

All travelers inbound to Japan must receive a negative PCR test within 72 hours of flight departure. These tests must be presented in the prescribed format and must comply with stringent requirements.

Regardless of the international point of origin, all travelers entering Japan remain subject to a 14-day self-quarantine upon arrival and are prohibited from using public transportation to include domestic flights, taxis, and rail.

Vaccination status has no impact on an individual’s eligibility to travel to Japan, and Japan’s quarantine restrictions apply regardless of vaccination status.

Travelers arriving from specific areas or without proof of pre-departure COVID-19 testing may be required to quarantine for some time in a government-designated location. U.S. military and SOFA status personnel should speak with their command about upcoming travel, COVID-19 testing, and any restriction of movement (ROM)/quarantine requirements.

Travelers seeking to transit Japan en route to onward international destinations may continue to do so without quarantine as long as the transit occurs within the same airport and no overnight stay is required.

The U.S. Embassy strongly urges any U.S. citizens considering travel to Japan to review the information available from the Government of Japan carefully. These complex regulations are subject to change with little notice.

The U.S. Embassy strongly urges U.S. citizens to monitor local news for updates to guidance for their area and comply with all local and national COVID-19 mitigation measures. Non-compliance with declaration may be punishable by fine as enforced by Japan’s Special Measures laws.

The U.S. Embassy’s ability to intervene on behalf of travelers denied boarding at their point of embarkation or denied entry upon arrival to Japan is extremely limited. Those travelers denied access at Japanese ports of entry would likely be immediately reboarded on flights back to the United States.

The U.S. Embassy and consulates are open for routine services, but appointment availability remains limited. Availability will be even more limited during Japan’s Golden Week celebrations. To schedule an appointment, visit the website for instructions.

Vax-Before-Travel publishes research-based travel news.

Sub Title:

US CDC says travelers should avoid all nonessential travel to Japan

References:

CDC: COVID-19 in Japan

US Embassy & Consulates in Japan: US Citizen Services

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Thursday, April 29, 2021 - 06:15

Digital Technology Speeds Up TSA Security Lines

Don Hackett — Tue, 20 Apr 2021 12:48:42 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The US Transportation Security Administration (TSA) confirmed ‘it is ready for the continued surge in travelers across the country.’

According to the TSA’s data, on April 18, 2021, over 1.5 million airline passengers were screened. This news indicates the USA travel industry had recovered from 2020 when only 105,382 passengers were screened on the corresponding day.

However, when contrasted to 2019’s activity of about 2.3 million screened travelers, the travel industry’s volume is well below maximin consumer demand.

But as people prepare to fly after what could be a year, the TSA offers various tips for navigating the airport checkpoint. The first is to leave guns at home or declare it to the airline and place it in a locked, hard-sided case in your checked baggage.

Last week a 38-year-old man brought a loaded Ruger to the Baton Rouge Metropolitan Airport (BTR) checkpoint and now faces a fine from the TSA that could exceed $13,000.

“The health and safety of our workforce and the traveling public remain our critical mission,” stated Arden Hudson, Federal Security Director with the TSA for the State of Louisiana, in a media statement.

“In addition to new technology, the TSA has installed acrylic barriers to separate passengers and TSA officers at strategic locations in the checkpoint at BTR.”

The TSA and Baton Rouge airport leadership previously announced the latest checkpoint technology, known as CT 300s, and added additional equipment to reduce touchpoints – CATs or credential authentication technology.

The CTs or computed tomography equipment uses complex algorithms to search for threats, allows TSA officers to rotate the images, reduces the need to open bags, and reduces touchpoints.

Passengers screened in the security lanes with this new equipment do not need to remove their 3-1-1 bag or their electronics.

Baton Rouge has also received the latest credential authentication technology, which also allows for fewer touchpoints.

Passengers are separated from TSA officers by acrylic barriers and then only need to pass them their ID or passport. Boarding passes are not required at the checkpoint. The equipment verifies passengers’ identities and confirms that they are flying that day.

“We appreciate that TSA has provided BTR with the latest technology and safety measures for our community,” said Mike Edwards, Director of Aviation at Baton Rouge Metropolitan Airport.

Face masks for both employees and passengers are required throughout all domestic transportation modes, including airport security screening checkpoints and throughout the airport.

Since implementing the federal face mask mandate for travelers on Feb 2, 2021, masks are required regardless of any local or state easing of restrictions. Those who refuse to wear masks are subject to fines from the TSA and the Federal Aviation Authority if the infraction occurs while flying.

Additionally, ‘Travel with Ease TSA PreCheck program members avoid removing shoes, belts, laptops, and light jackets. Most new enrollees receive a known traveler number within five days, and membership lasts for five years.

The U.S. TSA is committed to supporting a healthy and secure environment for our employees, airport personnel, and airline passengers. For additional information about TSA procedures during COVID-19 as part of our “Stay Healthy. Stay Secure” campaign, visit tsa.gov/coronavirus.

Vax-Before-Travel publishes research-based travel news.

Sub Title:

Transportation Security Administration computed tomography equipment (CT 300) uses complex algorithms to search for threats

References:

TSA in Baton Rouge Is Ready for Increasing Passenger Volumes Remember These Travel Tips As You Prepare to Fly Once Again

TSA checkpoint travel numbers (current year(s) versus prior year/same weekday)

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Tuesday, April 20, 2021 - 05:30

Mixing COVID-19 Vaccine Study Adds Two Other Vaccines

Don Hackett — Fri, 16 Apr 2021 03:02:32 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Researchers conducting the Com-Cov clinical study investigating alternating doses of the AstraZeneca and the Pfizer-BioNTech COVID-19 vaccines announced that the program now includes the Moderna and Novavax vaccines.

Study volunteers will receive either the AstraZeneca or Pfizer vaccine, will be randomly allocated to receive either the same vaccine for their second dose or a dose of the COVID-19 vaccines produced by Moderna or Novavax.

The six new ‘arms’ of the Com-Cov trial will each recruit 175 candidates, adding a further 1,050 recruits into this innovative program.

Led by the University of Oxford, run across nine National Institute for Health Research supported sites by the National Immunisation Schedule Evaluation Consortium, and backed through funding from the Vaccines Taskforce and the Coalition for Epidemic Preparedness Innovations, the additional study will seek to recruit adults aged over 50 who have received their first, or ‘prime’ vaccination in the past 8-12 weeks.

Matthew Snape, Associate Professor in Paediatrics and Vaccinology at the University of Oxford, and Chief Investigator on the trial stated in a press release issued on April 13, 2021, ‘The focus of both this and the original COM-COV study is to explore whether the multiple COVID-19 vaccines that are available can be used more flexibly.”

‘If we can show that these mixed schedules generate an immune response that is as good as the standard schedules, and without a significant increase in the vaccine reactions, this will potentially allow more people to complete their COVID-19 immunization course more rapidly.”

Maryland-based Novavax, Inc. confirmed on April 14th its recombinant protein vaccine candidate, NVX-CoV2373, is one of four COVID-19 vaccines that will be studied to evaluate the potential for combined regimens.

"Novavax' addition to this important study reflects the urgency of finding innovative ways to protect as many people as possible in a dynamic pandemic landscape," commented Filip Dubovsky, M.D., EVP, CMO, Novavax.

"The potential utility of pooling public health resources, including all available vaccines, could help us get ahead of an evolving virus."

Under the protocol, which is designed as a non-inferiority study, participants will be followed for reactogenicity (safety) and immune responses. The UK Medicines and Healthcare products Regulatory Agency (MHRA) and Joint Committee on Vaccination and Immunisation (JCVI) will formally assess the safety and efficacy of any new vaccination regimen before it is made available to the public.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the U.K that demonstrated the efficacy of 96.4% against the original virus strain and 89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020.

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease.

NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies.

NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

As of April 15, 2021, the NVX-CoV2373 vaccine candidate has not received emergency authorization from either the U.S FDA or the European Medicines Agency.

PrecisionVaccinations publishes research-based news.

Note: updated for clarity.

Sub Title:

Novavax NVX-CoV2373 vaccine candidate joins University of Oxford Com-COV2 Mixed COVID-19 Vaccine study

References:

Alternating vaccines trial expands to include two additional vaccines

Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

NVX-CoV2373 COVID-19 Vaccine

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Friday, April 16, 2021 - 05:00

Attending Japan’s Olympic and Paralympic Games Comes With Risks

Don Hackett — Thu, 15 Apr 2021 18:23:19 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

The British Medical Journal (BMJ) published an editorial on April 14, 2021, highlighting the health risks related to the 2020 Olympics rescheduled in Japan in late July 2021.

Excerpts from this BMJ article are included below:

‘In February 2021, the G7 leaders confirmed their support of Japan’s commitment to holding the Olympics and Paralympics in Tokyo (Tokyo 2020) “safely and securely… as a symbol of global unity in overcoming covid-19.’

While the determination is encouraging, there has been a lack of transparency about the benefits and risks of an international mass gathering event such as Tokyo 2020.

The world is still in the middle of the COVID-19 pandemic. SARS-CoV-2 variants are an international concern, causing a resurgence of covid-19 globally.

We must accelerate efforts towards ending the pandemic by maintaining public health and social measures, promoting behavior change, disseminating vaccines widely, and strengthening health systems.

Substantial scientific advancements have occurred over the past year, but vaccine rollout has been inequitable, reducing access in many low and middle-income countries. Huge uncertainty remains about the trajectory of the pandemic.

Although a unique scheme for vaccinating athletes—marshaled by the International Olympic Committee—may help save lives. It could also undermine global solidarity and promote vaccine nationalism. Full transparency and clear lines of accountability are critical in any scheme to vaccinate athletes.

Unlike other countries in the Asia-Pacific region, Japan has not yet contained covid-19 transmission.

The second state of emergency in the Greater Tokyo area was lifted in late March 2021, despite early indications of a resurgence and an increase in covid-19 patients with variants of concern, which have now spread across Japan.

To adequately protect athletes from COVID-19, Japan must develop and implement a clear strategy to eliminate community transmission within its borders, as Australia did before the Australian Open tennis tournament in 2021.

Waiving quarantine for incoming athletes, officials, broadcasters, press, and marketing partners risks importing and spreading COVID-19 variants of concern.

While international spectators will be excluded from the games, cases could rise across Japan and be exported globally because of increased domestic travel.

Plans to hold the Olympic and Paralympic Games this summer must be reconsidered as a matter of urgency. The whole global community recognizes the need to contain the pandemic and save lives.

Holding Tokyo 2020 for domestic political and economic purposes— ignoring scientific and moral imperatives—contradicts Japan’s commitment to global health and human security.

We must reconsider this summer’s games and instead collaborate internationally to agree on a set of global and domestic conditions under which international multisport events can be held in the years ahead.

These conditions must embody both Olympic and Paralympic values and adhere to international principles of public health,’ concluded this editorial. The views expressed in this editorial are those of the authors.

As of April 2, 2021, the U.S. CDC issued a Level 2 Travel Alert saying ‘travelers at increased risk for severe illness from COVID-19 should avoid all nonessential travel to Japan. If you travel to Japan, get fully vaccinated before travel.’

The CDC recently issued a news Level 4 Travel Alert on April 12th, recommending that all people avoid travel on cruise ships, including river cruises, worldwide.

The CDC suggests prospective visitors to Japan speak with a healthcare provider regarding travel vaccines about one month before departure. And use the CDC’s Healthy Travel Packing List for Japan.

Vax-Before-Travel publishes research-based travel vaccine news.

Sub Title:

Conducting Olympic games during the COVID-19 pandemic presents health risks

References:

Reconsider this summer’s Olympic and Paralympic games

CDC: COVID-19 in Japan

CDC: COVID-19 and Cruise Ship Travel

Travel Vaccines

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Saturday, April 17, 2021 - 15:45

J&J COVID-19 Vaccinations Paused in the USA

Don Hackett — Tue, 13 Apr 2021 13:20:06 +0000

Reviewer:

Robert Carlson, MD

The US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration issued a ‘pause’ recommendation for future vaccinations in the USA with the experimental Johnson & Johnson - Janssen COVID-19 Vaccine.

UPDATE: A virtual emergency meeting of the CDC's ACIP will be held to discuss the Janssen COVID-19 vaccine on April 23, 2021, from 11:00 a.m. to 5:00 p.m. ET.

The CDC and FDA confirmed they are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Janssen vaccine. All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

‘Right now, these adverse events appear to be extremely rare,’ stated the CDC’s announcement.

Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots.

In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

The CDC confirmed it is convening a meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14, 2021, to review these cases further and assess their potential significance.

In Europe, the European Medicines Agency announced a similar thromboembolic event alert regarding the Janssen COVID-19 vaccine on April 9, 2021.

The FDA stated it too would review the analysis as it also investigates these cases.

‘Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,’ stated these US government agencies.

‘This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.’

‘COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.’

‘People who have received the J&J vaccine who develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.’

‘Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at VAERS.'

The CDC verified it intends to provide additional information and answer questions later at a media briefing on April 13th. A recording of that session will be available on the FDA’s YouTube channel.

The Johnson and Johnson Janssen COVID-19 single-shot experimental vaccine leverages Janssen's technologies. Janssen’s AdVac® vectors are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease.

Adenoviruses are a group of viruses that can cause the common cold, says the CDC.

On February 27, 2021, the FDA issued an emergency use authorization allowing the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

As of April 13, 2021, this COVID-19 vaccine has not been ‘Approved’ by the FDA.

Note: These agency statements are attributed to Dr. Anne Schuchat, Principal Deputy Director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

PrecisionVaccinations publishes research-based news.

Updated for relevancy.

Sub Title:

Johnson and Johnson - Janssen COVID-19 single-shot experimental vaccine is based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease

References:

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021

CDC: New Clinical Practice Guidelines for Venous Thromboembolism

Janssen COVID-19 Vaccine

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Tuesday, April 13, 2021 - 08:00

Adults Found More Infectious than Children with SARS-CoV-2

Don Hackett — Mon, 12 Apr 2021 21:18:41 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

According to research published by the Canadian Medical Association Journal, children may be less involved in spreading the SARS-CoV-2 coronavirus to others.

Fourteen researchers from multiple disciplines at Canadian institutions analyzed samples from children and adults in Manitoba infected with SARS-CoV-2 to see if there was a difference in infectiousness.

Using cell cultures of nasopharyngeal swabs, they investigated viral loads in both groups to determine if children were more infectious.

This study published on April 9, 2021, concluded children were not as infectious as adults.

Among 305 samples positive for SARS-CoV-2 by RT-PCR, 97 samples were from children aged ten years or younger, 78 were from children aged 11–17 years, and 130 were from adults (≥ 18 yr).

Viral growth in culture was present in 31% of samples, including 18 (19%) samples from children ten years or younger, 18 (23%) from children aged 11–17 years, and 57 (44%) from adults (children v. adults, odds ratio 0.45, 95% confidence interval [CI] 0.28–0.72).

The cycle threshold was 25.1 (95% CI 17.7– 31.3) in children ten years or younger, 22.2 (95% CI 18.3–29.0) in children aged 11–17 years, and 18.7 (95% CI 17.9–30.4) in adults (p < 0.001).

The median TCID50/mL was significantly lower in children aged 11–17 years (316, interquartile range [IQR] 178–2125) than adults (5620, IQR 1171 to 17 800, p < 0.001).

Cycle threshold was an accurate predictor of posi-tive culture in both children and adults (area under the receiver-operator curve, 0.87, 95% CI 0.81–0.93 v. 0.89, 95% CI 0.83–0.96, p = 0.6).

"Our findings have important public health and clinical implications," wrote principal investigator Dr. Jared Bullard, associate professor, pediatrics/child health and medical microbiology/infectious diseases, Max Rady College of Medicine, University of Manitoba, and associate medical director, Cadham Provincial Laboratory in Winnipeg, Manitoba.

"If younger children are less capable of transmitting infectious virus, daycare, in-person school and cautious extracurricular activities may be safe to continue, with appropriate precautions in place, and with lower risk to child care staff, educators and support staff than initially anticipated."

Compared with adults, the study authors wrote that children with nasopharyngeal swabs that tested positive for SARS-CoV-2 were less likely to grow the coronavirus in culture. They had higher cycle thresholds and lower viral concentrations suggesting that children are not the main drivers of SARS-CoV-2 transmission.

"This is particularly important given the increased likelihood of asymptomatic infection in this group."

CoronavirusToday publishes research-based news.

Sub Title:

Canadian children positive for SARS-CoV-2 were found less likely to grow the coronavirus in culture and had higher cycle thresholds and lower viral concentrations

References:

Infectivity of severe acute respiratory syndrome coronavirus 2 in children compared with adults

Children less infectious than adults with SARS-CoV-2

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Tuesday, April 13, 2021 - 05:15

Research Demonstrates Novel Mechanisms by Which SARS-CoV-2 Enters Host Cells

Don Hackett — Thu, 08 Apr 2021 19:40:03 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

A San Francisco-based immunology company announced new preclinical research highlighting novel mechanisms by which SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) enters host cells and identifying how auxiliary receptors may impact the clinical efficacy of monoclonal antibodies (mAbs).

The non-peer-reviewed research highlights the distinct mechanism of action of a non-receptor-binding motif (RBM)-targeting antibodies, such as Vir Biotechnology, Inc. VIR-7831 and VIR-7832, the Company’s investigational SARS-CoV-2 mAbs that target a conserved non-RBM site within the receptor-binding-domain (RBD).

While prior literature has shown that the virus binding mediates a SARS-CoV-2 infection to the ACE-2 entry receptor, findings from this new research posted on BioRxiv highlight the importance of three additional auxiliary receptors that enhance infection mediated by the ACE-2 receptor.

This study addresses the role of DC-SIGN and L-SIGN lectins in infection and further identifies the SIGLEC1 lectin as a new participant in infection.

SIGLEC1 is of particular importance because it is highly expressed and associated with SARS-CoV-2 in macrophages – an inflammatory cell type prominent in the lungs of patients with severe COVID-19.

These cells can bind to infectious SARS-CoV-2 and present the virus to another cell to establish infection in that second cell.

These auxiliary receptors also play an essential role in modulating the neutralizing activity of different classes of spike-specific antibodies. They may contribute to viral dissemination in the most severe COVID-19 cases.

This study addresses another important aspect of the influence of the experimental methods used in measuring the neutralizing activity of different classes of spike-specific antibodies.

Cells that overexpress ACE-2 at levels above normal cells are widely used in neutralization assays because they can be infected with high efficiency.

While these cell lines effectively measure the neutralizing activity of antibodies that target the RBM of the SARS-CoV-2 spike protein, they inadequately measure the neutralizing activity of non-RBM antibodies, as well as antibodies that target the N-terminal domain (NTD) of the spike.

The NTD is a major target of human immunity to SARS-CoV-2.

This observation indicates the significant limitations of using cells overexpressing ACE-2 for studies of mAbs and measuring serum neutralizing antibodies elicited by vaccination or infection.

When tested in more physiologic conditions, with cells expressing low levels of ACE-2 together with lectin receptors, non-RBM antibodies showed an enhanced ability to block viral infection.

S309 (the precursor to VIR-7831 and VIR-7832), which targets a conserved non-RBM site within the RBD, showed enhanced neutralizing activity, reaching 100% neutralization.

In contrast, antibodies that target the RBM were less effective in preventing infection.

Additionally, a subset of the RBM-targeting antibodies analyzed in the study, including three clinical-stage antibodies, was shown to promote cell-cell fusion driven by the SARS-CoV-2 spike protein, potentially enabling the cell-to-cell spread of the infection.

“As we continue to advance research that elucidates the mechanisms of SARS-CoV-2 infection, including the development of the disease and immunity to infection, one consistent finding of this study appears to be that certain classes of mAbs have potential advantages at blocking auxiliary receptor-enhanced infection” stated Herbert “Skip” Virgin, M.D., Ph.D., chief scientific officer of Vir, in a related press release.

“These data, together with recent studies showing an 85% reduction in hospitalization and death in high-risk outpatients receiving VIR-7831 compared to placebo and promising performance against SARS-CoV-2 variants in the lab, add to the growing body of evidence suggesting that antibodies that bind to a conserved non-RBM site of the virus are well suited to help treat and/or prevent COVID-19 infection and have the potential to address both current and future mutations.”

VIR-7831 and VIR-7832 are investigational compounds not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

Recently, GlaxoSmithKline plc and Vir applied to the FDA on March 26, 2021, requesting Emergency Use Authorization for VIR-7831 (GSK4182136) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.

This FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization.

California-based Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.

PrecisionVaccinations publishes research-based news.

Sub Title:

Monoclonal antibodies that target a conserved epitope have the potential to be highly effective against SARS-CoV-2 and associated known mutations

References:

Membrane lectins enhance SARS-CoV-2 infection and influence the neutralizing activity of different classes of antibodies

Vir Biotechnology Announces New Research Demonstrating Novel Mechanisms by Which SARS-CoV-2 Enters Host Cells

GSK and Vir Biotechnology Announce Submission of Emergency Use Authorization Request to FDA for VIR-7831 for the Early Treatment

VIR-7831 Anribody

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Friday, April 9, 2021 - 06:45