COVID-19

U.S. Changes COVID-19 Vaccination Policy

Donald Hackett — Wed, 21 May 2025 08:51:51 +0000

Reviewer:

The U.S. Food and Drug Administration (FDA) announced updates to its COVID-19 vaccination recommendations today, as the U.S. population has grown tired of the current policy.

According to the Centers for Disease Control and Prevention, fewer than 25% of Americans received boosters yearly over the past two seasons.

Even healthcare workers are hesitant about vaccination, with less than one-third participating in the 2023–2024 fall booster program.

In an article published in the New England Journal of Medicine on May 20, 2025, FDA Commissioner Dr. Martin Makary and Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, stated that these changes align the United States with the practices of many other countries.

'While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe COVID-19, the U.S. (government) has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of six months.'

'The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations.

'We reject this view,' wrote these FDA leaders.

'The FDA's new COVID-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.'

'These clinical trials will inform future directions for the FDA, but more importantly, they will provide information that health care providers and the American people desperately crave.'

This entire, unedited article is posted at this link.

Sub Title:

Clinical evidence required for COVID-19 vaccinations

Reference:

An Evidence-Based Approach to Covid-19 Vaccination

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US FDA 2025

The WHO Clarifies Antigen Composition of COVID-19 Vaccines

Donald Hackett — Thu, 15 May 2025 14:39:25 +0000

Reviewer:

Robert Carlson, MD

The World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) today confirmed it continues to closely monitor the genetic and antigenic evolution of SARS-CoV-2 variants, immune responses to SARS-CoV-2 infection and COVID-19 vaccination, and the performance of COVID-19 vaccines against circulating variants.

As of May 2025, the currently circulating SARS-CoV-2 variants are derived from JN.1.

Multiple manufacturers (using mRNA, recombinant protein-based, and adenovirus-vectored platforms) have updated their COVID-19 vaccines, such as Novavax Inc. Novavax's recombinant protein-based vaccine is the only non-mRNA COVID-19 vaccine available in the United States.

On May 15, 2025, the TAG-CO-VAC advised manufacturers that monovalent JN.1 or KP.2 vaccines remain appropriate vaccine antigens; monovalent LP.8.1 is a suitable alternative vaccine antigen.

The WHO says, 'The objective of an update to COVID-19 vaccine antigen composition is to enhance vaccine-induced immune responses to circulating SARS-CoV-2 variants.'

'Overall, the currently approved monovalent JN.1 or KP.2 vaccines continue to elicit broadly cross-reactive immune responses to circulating JN.1-derived variants.'

As previously stated, the TAG-CO-VAC continues to encourage the further development of vaccines that may improve protection against infection and reduce transmission of SARS-CoV-2. Previous statements from the TAG-CO-VAC can be found on the WHO website.

Sub Title:

COVID-19 Vaccines remain available in May 2025

Reference:

WHO Statement on the antigen composition of COVID-19 vaccines

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WHO May 15, 2025

Protein-based COVID-19 Vaccine Now Available at Thousands of Pharmacies

Donald Hackett — Fri, 13 Sep 2024 19:07:58 +0000

Reviewer:

Robert Carlson, MD

Novavax, Inc. today announced that doses of the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) to prevent COVID-19 in individuals aged 12 and older are in stock at major pharmacy retailers across the United States.

As of September 13, 2024, Novavax's updated protein-based vaccine is expected to be available in CVS Pharmacy, Rite Aid, Walgreens, Costco, Publix, Sam's Club, Kroger, Meijer, hundreds of other regional grocers and thousands of independent pharmacies.

Novavax's vaccine is the only protein-based option available in the fall season, and distribution locations are listed at us.novavaxcovidvaccine.com.

"We have worked hard to ensure greater ease of access for consumers this vaccination season by more than doubling the number of locations stocking our vaccine compared to last year and offering a more convenient presentation in a prefilled syringe," said John C. Jacobs, President, and Chief Executive Officer, Novavax, in a press release.

"Our vaccine targets JN.1, the 'parent strain' of those currently circulating, and our vaccine has demonstrated cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1."

Novavax's updated vaccine received Emergency Use Authorization on August 30, 2024, from the U.S. Food and Drug Administration.

"As of September 13, 2024, Novavax COVID-19 vaccine for individuals 12 and older is available at major pharmacy retailers across the U.S. in a prefilled syringe. And since Novavax is the only protein-based COVID-19 vaccine currently available, consumer demand may go up," says Jeanne Waggener, RPh.

"Novavax acts by targeting JN.1, the 'parent strain' of those viruses circulating. It also demonstrates cross-reactivity against the JN.1 lineage COVID viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.1.," added Waggener, a Precision Vaccination News Contributing Expert.

Novavax is a global company advancing vaccines such as R21/Matrix-M™, which includes the company's proprietary saponin-based Matrix-M adjuvant and is licensed to and manufactured by the Serum Institute of India Private Ltd.

Note: Waggener Contributing Expert insight inserted on Sept. 17, 204.

Sub Title:

Pharmacy retailers administering Novavax COVID-19 Vaccine, Adjuvanted, 2024-2025 Formula

Reference:

Novavax 2024-2025 Formula COVID-19 Vaccine Available at Major Pharmacies Across the U.S.

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Novavax pharmacy distributors 2024

India's First Indigenous COVID-19 Vaccine Resolves Unintentional Omission

Donald Hackett — Sun, 23 Jun 2024 16:38:28 +0000

Reviewer:

Robert Carlson, MD

Bharat Biotech International Limited (BBIL) recently stated X that the company unintentionally omitted the Indian Council of Medical Research (ICMR) as a co-owner of the inactivated COVAXIN® vaccine patent.

On June 22, 2024, the Hyderabad-based vaccine producer Tweeted that it was taking legal action to correct this issue.

According to media reporting, ICMR was to receive a 5% royalty on net sales and product branding rights, which include 'co-inventor' status.

COVAXIN was developed from a SARS-CoV-2 coronavirus strain isolated at the National Institute of Virology, under the ICMR. The government health research agency also supported the vaccine's clinical development through assistance in conducting clinical trials.

This non-mRNA vaccine was developed using Whole-Virion Inactivated Vero Cell-derived platform technology.

During the initial stages of the recent pandemic, the World Health Organization Listed the COVAXIN vaccine as effective in November 2021.

BBIL says inactivated vaccines do not replicate and are unlikely to revert and cause pathological effects. They contain dead viruses, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.

However, a report published in Springer Nature in August 2023 found certain people were at a higher risk of adverse events after receiving COVAXIN.

As of June 2024, COVAXIN is available in about 14 countries, but not the United States.

Sub Title:

Bharat Biotech may own Indian Council of Medical Research 5% royalties on vaccine sales

References:

The Print

June 22, 2024 Tweet on X

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by Jens P. Raak

US FDA Deviates From WHO's COVID-19 Vaccine Advice

Donald Hackett — Fri, 14 Jun 2024 18:28:09 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

When the World Health Organization (WHO) recently announced its recommendations for updating COVID-19 vaccines, many scientists focused on the continued evolution of the SARS-CoV-2 coronavirus and its potential impact on vaccine efficacy.

Since late 2019, several virus variants have been detected since the initial identification.

On April 26, 2024, the WHO Technical Advisory Group on COVID-19 Vaccine Composition stated that the virus is expected to continue evolving from JN.1 and advised the use of a monovalent JN.1 lineage as the antigen in future formulations of COVID-19 vaccines.

This WHO advice greatly influences the global rollout of COVID-19 vaccines. To date, the WHO has issued 13 COVID-19 vaccines Emergency Use Listing.

On June 13, 2024, the U.S. Food and Drug Administration (FDA) stated it has continued to monitor the circulating strains of SARS-CoV-2.

Based on the most current available data and the recent rise in COVID-19 cases in the U.S., the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible.

This FDA determination is a change from last week's vaccine advisory meeting.

On June 6, 2024, the FDA initially advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the U.S. beginning in fall 2024 should be monovalent JN.1 vaccine.

The FDA's change is intended to ensure that the COVID-19 vaccines (2024-2025 Formula) more closely match currently circulating SARS-CoV-2 strains.

FDA stated in a media release that it has communicated this change to the manufacturers of the licensed and authorized COVID-19 vaccines. The agency does not anticipate that a change to KP.2 will delay the availability of the vaccines in the U.S.

Following the FDA's announcement, Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, announced that it had submitted an amendment to its Emergency Use Authorization to the FDA for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.

Novavax wrote on June 14, 2024, that its submission aligns with guidance from the U.S. FDA, the European Medicines Agency, and the WHO to target the JN.1 lineage this fall.

Novavax's JN.1 vaccine has recently demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants.

Numerous countries currently deploy Novavax's COVID-19 vaccine.

Sub Title:

Novavax protein based JN.1 vaccine demonstrated broad cross neutralizing antibodies against multiple variant strains including KP.2 and KP.3

References:

FDA Updates Advice to Manufacturers of COVID-19 Vaccines

WHO Statement on the antigen composition of COVID-19 vaccines

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Following 15-day Paxlovid Regimen, Long COVID Benefits Absent

Donald Hackett — Mon, 10 Jun 2024 17:24:03 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

Stanford Medicine researchers recently reported that an often-prescribed medication for treating COVID-19 did not produce measurable benefits for those suffering from Long COVID.

This disappointing news affects millions of people who are taking Pfizer Inc. Paxlovid™ to combat Long COVID.

A survey by the Agency for Healthcare Research and Quality recently concluded almost 18 million adults have ever had Long COVID.

And a recent JAMA Data Brief disclosed adults who had received a COVID-19 booster had lower rates of Long COVID than those who had only received the primary series vaccination and those who had never been vaccinated.

This Original Investigation, published by the journal JAMA Internal Medicine on June 7, 2024, concluded that this randomized phase 2 clinical trial demonstrated the overall safety of a 15-day course of Paxlovid in patients with postacute sequelae of SARS-CoV-2 infection (PASC) but did not find a significant benefit of this therapy for a subset of PASC symptoms among a mostly vaccinated cohort with prolonged PASC symptoms.

These Stanford researchers identified an important issue.... No validated clinical endpoints or biomarkers of PASC have been established for clinical trials to date. The symptoms selected for this study were based on mechanistic rationale and patient prevalence and severity.

According to the National Academies of Sciences, Engineering, and Medicine, there are about 200 Long COVID symptoms.

Results from the NIH-Pfizer sponsored STOP-PASC clinical trial found that a 15-day course of Paxlovid had a safety profile similar to the 5-day acute treatment course and was generally tolerated.

However, compared to placebo-ritonavir, it did not improve select PASC symptoms (fatigue, brain fog, body aches, cardiovascular symptoms, shortness of breath, and gastrointestinal symptoms) or other health outcomes.

That could be good news, as it indicates that Long COVID symptoms subside with time, as these researchers have stated.

On the other hand, there's the possibility of a placebo effect: The extra attention and concern from nurses, doctors, and other health-provider types, as well as the hope of relief from the drug, may nudge placebo recipients to sense subjective improvement — or even to experience objective improvement — in their condition.

These researchers stated that it is essential to underscore that this study alone does not rule out Paxlovid as a potential therapy for PASC. Multiple reasons would explain why this trial did not detect a benefit for the selected outcomes, and several key themes warrant further discussion to inform future trials in PASC.

Co-principal investigator Upinder Singh, MD, professor and chief of infectious disease and geographic medicine and microbiology and immunology, commented in a press release, "Some studies suggest that viral particles and molecular debris could be responsible for some Long COVID sufferers."

"We figured if that's the case, maybe treating them with Paxlovid could relieve some of these symptoms."

'Our study cohort had protracted PASC illness averaging more than 16 months, and antivirals may need to be administered earlier in the illness before downstream and possibly less reversible adverse effects occur."

"We hope to report on our analyses of these measurements in four to six months," Singh said.

Researchers from Kaiser Permanente North California and Pfizer contributed to this research.

A previous study published in the Journal of Medical Virology in January 2024 by a team of researchers from UC San Francisco also found that Paxlovid did not reduce the risk of developing Long COVID for vaccinated, non-hospitalized individuals during their first COVID-19 infection.

Sub Title:

Stanford Medicine researchers report short term Paxlovid regimen was safe

References:

The STOP-PASC Randomized Clinical Trial

Stanford Medicine trial: 15-day Paxlovid regimen safe but adds no clear long-COVID benefit

Association of nirmatrelvir for acute SARS-CoV-2 infection with subsequent Long COVID symptoms

About 7% of US Adults Have Had Long COVID

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JAMA June 2024

200 Long COVID Symptoms Could Last Years

Karen McClorey Hackett — Wed, 05 Jun 2024 20:18:22 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Since the COVID-19 pandemic began in late 2019, many people who contracted the SARS-CoV-2 coronavirus have been experiencing symptoms for extended periods, sometimes lasting for months or even years.

According to the Centers for Disease Control and Prevention, about 17% of Americans have experienced Long COVID.

Today, the National Academies of Sciences, Engineering, and Medicine released a new report to clarify which symptoms are associated with a Long COVID diagnosis.

This report highlights over 200 symptoms associated with Long COVID and states that a positive COVID-19 test is not required to diagnose the condition.

The new report published on June 5, 2024, says that some health effects of Long COVID, including chronic fatigue and post-exertional malaise, cognitive impairment (sometimes referred to as “brain fog”), and autonomic dysfunction, can impair an individual’s ability to work or attend school for six months to two years or more after COVID-19 infection.

It can be difficult to assess these health effects clinically or to determine their severity and impact on a person’s ability to function.

They also may not be captured in the Social Security Administration’s Listing of Impairments, which is used as an initial screening step in determining disability.

A more significant number of or more severe Long COVID symptoms are correlated with decreased quality of life, physical functioning, and ability to work or perform in school.

“Diagnosing, measuring, and treating Long COVID is complicated. This disease, which has existed in humans for less than five years, can present differently from person to person and can either resolve within weeks or persist for months or years,” said Paul Volberding, professor emeritus in the Department of Medicine at the University of California, San Francisco, and chair of the committee that wrote the report.

“Our report seeks to offer a clear summary of what research has found so far about diagnosing Long COVID, and what the disease can mean for an individual’s ability to function in their daily lives," said Volberding in a press release.

The report estimates that people whose infection was sufficiently severe to necessitate hospitalization are 2 to 3 times more likely to experience Long COVID than those who were not hospitalized.

Among individuals who were hospitalized, those requiring life support in an intensive care unit may be twice as likely to experience Long COVID.

However, people with mild disease can also develop Long COVID, and given the much higher number of people with mild versus severe disease, they make up the majority of people with Long COVID.

As of June 2024, no curative treatment or vaccine for Long COVID exists.

Management of the condition is based on current knowledge about treating its symptoms and health effects. As with other complex chronic health conditions, medical treatment for Long COVID is focused on managing symptoms and optimizing quality of life and function.

Recovery from Long COVID varies among individuals, and the data on recovery trajectories are rapidly evolving.

Based on recent U.S. CDC discussions, upgraded COVID-19 vaccines may alleviate some Long COVID infections in 2024-2025.

Undertaken by the Committee on the Long-Term Health Effects Stemming from COVID-19 and Implications for the Social Security Administration, the study was sponsored by the U.S. Social Security Administration.

Sub Title:

Long COVID diagnosis challenges healthcare providers

References:

National Academies of Sciences, Engineering, and Medicine

CDC Long COVID Household Pulse Survey

Long COVID Definitions and Models of Care

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Facebook's Fact Checkers Failed to Flag Gray Vaccine Information

Donald Hackett — Mon, 03 Jun 2024 19:29:39 +0000

Reviewer:

Robert Carlson, MD

A recently published study by Science shows that unflagged, factual, but misleading Facebook posts reduced the intent to receive a vaccine 46 times more than false posts flagged by fact-checkers as misinformation.

The Massachusetts Institute of Technology and the University of Pennsylvania researchers introduced a method combining crowdsourcing, machine learning, and large-scale observational data for estimating the causal effect of social media on societal outcomes. They surveyed thousands about the influence of headlines from vaccine-related news stories on their intent to vaccinate.

Announced on May 31, 2024, they found that the impact of flagrant vaccine misinformation on Facebook was significantly attenuated once third-party fact-checkers flagged and debunked such posts as false.

However, ambiguous misinformation remained unflagged as this 'gray' area eluded fact-checkers..... factually accurate but deceptive content.

This unflagged content cast doubts on vaccine safety or efficacy and was more consequential for driving vaccine hesitancy than flagged misinformation.

They found that flagged misinformation causally lowers vaccination intentions, conditional on exposure.

Specifically, given the comparatively low exposure rates, this content had much less of a role in driving overall vaccine hesitancy compared with vaccine-skeptical content, much of it from mainstream outlets that were not flagged by fact-checkers.

These researchers concluded that the only content dimension that consistently predicted a headline's impact on vaccination intentions was the extent to which the headline suggested that the vaccine was harmful to the people.

This review suggests that while limiting the spread of misinformation has significant public health benefits, it is also critically important to consider gray-area content that is factually accurate but misleading.

Companies like Facebook assert that First Amendment free speech rights must protect unflagged content.

Furthermore, X, formerly known as Twitter, has deployed an innovative solution to fact-checker effectiveness.

A Research Letter published in JAMA on April 24, 2024, led by John W. Ayers, Ph.D., from the Qualcomm Institute within UC San Diego, finds that X''s Community Notes helped counter false vaccine information with accurate, credible responses.

"Since the World Health Organization declared vaccine misinformation a risk, there have been surprisingly few achievements to celebrate," said Ayers in a press release.

"X Community Notes have emerged as an innovative solution, pushing back with accurate and credible health information."

Traditionally, the most trusted vaccine information came from healthcare providers.

Regarding the most trusted healthcare providers, doctors and pharmacists are at the top of the list. During the recent pandemic, these main-street professionals played a crucial role in scaling up vaccinations throughout the U.S.

Sub Title:

Community Notes successfully confronts vaccine misinformation

Reference:

Quantifying the impact of misinformation and vaccine-skeptical content on Facebook

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Impact of flagged misinformation versus unflagged content 2024

$1.4 Billion Transaction Leverages Matrix-M Adjuvant Vaccine Technology

Donald Hackett — Fri, 10 May 2024 16:04:46 +0000

Reviewer:

Robert Carlson, MD

An international agreement that may reach $1.4 billion in value may disrupt the COVID-19 and influenza vaccine industry.

As part of Sanofi's commitment to developing a diverse portfolio of best-in-class vaccines, the company announced today it has entered into a co-exclusive licensing agreement with Novavax Inc., a global leader in protein-based, non-mRNA, adjuvanted COVID-19 vaccines.

The terms of the agreement disclosed on May 10, 2024, include but are not limited to, a co-exclusive license to co-commercialize Novavax's current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan, and South Korea where Novavax has existing partnership agreements).

A sole license to Novavax's adjuvanted COVID-19 vaccine for use in combination with Sanofi's flu vaccines.

And a non-exclusive license to use the Matrix-M adjuvant in vaccine products.

Furthermore, Sanofi will take a minority (<5%) equity investment in Gaithersburg, Maryland-based Novavax.

Jean-Francois Toussaint, Global Head of Vaccines R&D at Sanofi, said in a press release, "With flu and COVID-19 hospital admission rates now closely mirroring each other, we have an opportunity to develop non-mRNA flu-COVID-19 combination vaccines offering patients both enhanced convenience and protection against two serious respiratory viruses."

"We're excited by the prospect of combining Novavax's adjuvanted COVID-19 vaccine, which has shown high efficacy and favorable tolerability, with our rich portfolio of differentiated flu vaccines, which have demonstrated superior protection against flu and its serious complications."

"Regulators, recommending bodies, and patients will demand improved tolerability and thermostability without compromising efficacy."

Novavax offers a differentiated vaccine platform that enhances the immune response by combining a recombinant protein approach, innovative nanoparticle technology, and its patented Matrix-M adjuvant.

In addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine.

Novavax announced today its financial results and operational highlights for the first quarter ended March 31, 2024.

Sub Title:

Protein based COVID-19 vaccine producer Novavax partners with Sanofi

References:

Novavax Reports First Quarter 2024 Financial Results and Operational Highlights

Sanofi and Novavax announce co-exclusive licensing agreement

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by Gerd Altmann

Which Providers Will Influence the Most Vaccinations in 2024

Karen McClorey Hackett — Mon, 29 Apr 2024 20:33:49 +0000

Reviewer:

Robert Carlson, MD

When it comes to the most trusted healthcare providers, pediatricians and pharmacists are at the top of the list. During the COVID-19 pandemic, these main-street professionals played a crucial role in scaling up vaccinations.

A late March 2024 survey confirmed that pediatricians and pharmacists are key influencers regarding respiratory vaccinations, including flu shots.

For example, pharmacies administered about 67% of COVID-19 doses last year.

And for the Fall 2024 season, the American Academy of Pediatrics recommends that all children and adolescents receive routine immunizations on time.

The survey's highlighted findings include:

Parents are more likely to say they haven't had a conversation recently with their pediatrician about the COVID-19 vaccine (23%) than the flu vaccine (14%) or vaccines for other infectious diseases (14%).
Half (49%) of parents who have discussed the COVID-19 vaccine recently with their child's pediatrician say this conversation impacted their decision to vaccinate their child. However, this is lower than vaccines for other infectious diseases (59%).

"The CDC recommends that all children six months through five years of age receive at least one dose of an updated COVID-19 vaccine. When it comes to the best time to vaccinate your child, talk to a healthcare provider you trust," Mitchel Rothholz, RPh, MBA, FAPhA, informed Precision Vaccination News by email on April 29, 2024.

"Vaccinations are important to pediatric healthcare, and vaccine conversations are just as important."

"I am a big believer in collaboration, coordination, and communication among members of the immunization neighborhood."

"Pharmacists and other healthcare team members are happy to help and can discuss any questions or concerns to ensure you feel comfortable about the decisions you're making for your child."

Recently, the Pharmacy Podcast Network hosted a discussion of Pediatric Pharmacists, which discussed why pediatric pharmacists are important and how pediatric patients are a unique entity that requires specialized knowledge.

As healthcare providers prepare to answer next season's vaccination questions, the World Health Organization (WHO) recently offered some clarity.

The WHO determined in late April 2024 that future formulations of COVID-19 vaccines should aim to induce enhanced neutralizing antibody responses to JN.1 and its descendent lineages. And the continued use of the current monovalent XBB. 1.5 formulation will offer people protection.

Furthermore, vaccination programs should continue to use any WHO emergency-use listed or prequalified COVID-19 vaccines, and vaccination should not be delayed in anticipation of access to vaccines with an updated composition.

This March 2024 survey was commissioned by Moderna Inc. and conducted by Morning Consult between 3/15/24 and 3/23/24 among a national sample of 1,449 parents and 100 pediatricians.

Sub Title:

Pediatricians and pharmacists lead respiratory vaccinations

References:

Parental and Pediatricians’ Attitudes towards COVID-19 Vaccination for Children

Federal Retail Pharmacy Program Contributions to Bivalent mRNA COVID-19 Vaccinations Across Sociodemographic Characteristics

WHO - Statement on the antigen composition of COVID-19 vaccines

Vaccination Recommendations by the AAP

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Pre School

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Pediatric Pharmacists - Pharmacy Podcast Network

WHO Picks Antigen Composition for Updated COVID-19 Vaccines

Donald Hackett — Fri, 26 Apr 2024 18:18:10 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

As of April 2024, the World Health Organization (WHO) has determined that nearly all circulating SARS-CoV-2 variants reported in publicly available databases are JN.1 derived coronavirus variants.

On April 26, 2024, the WHO stated in a media release that virus evolution is expected to continue from JN.1, and future formulations of COVID-19 vaccines should aim to induce enhanced neutralizing antibody responses to JN.1 and its descendent lineages.

The WHO says the regular review of the available vaccine effectiveness evidence (VE) is critical to assessing future versions.

Given the neutralizing antibody responses to early JN.1 descendent lineage and the evidence from early Relative VE studies against JN.1, the continued use of the current monovalent XBB. 1.5 formulation will offer people protection.

Furthermore, by WHO SAGE policy, vaccination programs should continue to use any WHO emergency-use listed or prequalified COVID-19 vaccines, and vaccination should not be delayed in anticipation of access to vaccines with an updated composition.

This is essential news since recent research says people seek COVID-19 vaccine options in 2024.

In the United States, the WHO and the U.S. FDA have authorized Novavax Inc.'s protein-based COVID-19 vaccine.

Nuvaxovid™XBB.1.5 protein-based vaccine is currently used globally in individuals 12 and older who have previously been vaccinated with a COVID-19 vaccine and have not already been vaccinated with a recently updated mRNA COVID-19 vaccine.

John C. Jacobs, President and Chief Executive Officer of Novavax Inc., shared his perspective with Precision Vaccination News. "Novavax has been developing and manufacturing a monovalent protein-based JN.1 COVID-19 vaccine at-risk to ensure readiness for this fall."

"Today's recommendation by the WHO Technical Advisory Group on COVID-19 Vaccine Composition is an important step to help ensure access to a non-mRNA protein-based vaccine option for those at highest risk globally."

Novavax's vaccines integrate the company's proprietary nanoparticle technology, Matrix-M™, an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies.

As of April 2024, Novavax vaccines are generally available at pharmacies in the U.S.

The U.S. FDA previously announced that the Vaccines and Related Biological Products Advisory Committee will hold a public discussion on May 16, 2024, to recommend the selected strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.

Sub Title:

Pharmacies offer Novavax Nuvaxovid XBB.1.5 vaccines globally

References:

WHO Statement on the antigen composition of COVID-19 vaccines

WHO Technical Advisory Group on COVID-19 Vaccine Composition

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Gerd Altmann

Real World Evidence Supports Protein-based COVID-19 Vaccination

Donald Hackett — Fri, 12 Apr 2024 12:01:54 +0000

Reviewer:

Robert Carlson, MD

In the early stages of the recent pandemic, clinical studies reported differing levels of effectiveness for COVID-19 vaccines.

One reason for this was that people's immune composition was continuously changing due to new SARS-CoV-2 variants, booster doses, and updated vaccine types.

However, one missing data component was needed to understand these innovative vaccines' effectiveness fully.

Recently, real-world evidence was published that supports the continued use of protein-based COVID-19 vaccines.

A retrospective study published on April 4, 2024, utilized the German Disease Analyzer database to characterize recipients of Novavax Inc.'s protein-based NVX-CoV2373 (Nuvaxovid™) vaccine with its Matrix-M™ adjuvant and explore vaccination outcomes.

Overall, there were 597 recipients (mean age ~60 years) of NVX-CoV2373. After ten months of follow-up, 95% (95% CI, 93–95) of recipients were estimated to be protected from COVID-19.

Furthermore, health outcomes were similar across the primary series and booster populations.

This study was conducted while the Alpha, Delta, and early Omicron variants were in circulation and demonstrated the effectiveness of NVX-CoV2373 in a real-world population.

Real-world analyses such as this are informative during the dynamic evolution of the SARS-CoV-2 coronavirus.

The results from this study align with the Standing Committee on Vaccination recommendations and support the use of NVX-CoV2373 for all authorized populations, including those with comorbidities.

The outcomes from this study support NVX-CoV2373 as a viable alternative to mRNA vaccines for both primary series and boosters, broadening vaccine choice.

Notably, these researchers wrote that these analyses should be revisited as recommendations are released for vaccination against the most current circulating variants of interest/concern.

This research was funded by Novavax Europe, and the APC was funded by Novavax, Inc.

Separate from this study, new data from Novavax's ongoing research on its updated XBB.1.5 COVID-19 vaccine in participants who previously received an mRNA vaccine showed robust neutralizing antibody titers for the XBB.1.5 subvariant as well as for the currently circulating JN.1 subvariant.

The data also showed that the vaccine's safety and reactogenicity profile was consistent with its prototype vaccine (NVX-CoV2373).

From an access perspective, updated COVID-19 vaccines are readily available at pharmacies in the U.S.

For example, in Austin, Texas, Novavax vaccines are available at Costco, CVS, Publix, and Tarrytown Pharmacy pharmacies.

From a payment perspective, the U.S. CDC's Bridge Access Program continues offering free COVID-19 vaccines to adults without health insurance and adults whose insurance does not cover all COVID-19 vaccine costs.

Sub Title:

Protein-based Nuvaxovid vaccine delivers measurable protection

References:

Characteristics and Outcomes for Recipients of NVX-CoV2373: A Real-World Retrospective Study in Germany

Novavax Presents Data on Updated COVID-19 Vaccine

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by Gerd Altmann

Pharmacists Prepare to Administer Updated COVID-19 Vaccines This Fall

Karen McClorey Hackett — Mon, 08 Apr 2024 19:05:50 +0000

Reviewer:

Robert Carlson, MD

Throughout the last eighteen months, the most accessible healthcare provider on 'Main Street' took the leadership position in administering updated COVID-19 vaccines.

Thanks to the U.S. Federal Retail Pharmacy Program, pharmacists scaled up their vaccination capabilities to deliver 40.5 million COVID-19 vaccinations.

Approximately 90% of U.S. residents live within 5 miles of a community pharmacy that delivers walk-up and appointment-based vaccination services.

From September 2022 to September 30, 2023, 59.8 million COVID-19 bivalent vaccine doses were administered in the United States. In urban and rural areas, pharmacies administered 81.6% and 60% of bivalent vaccine doses, respectively.

According to the U.S. CDC's Morbidity and Mortality Weekly Report on April 4, 2024, pharmacies were integral partners in national efforts to scale up vaccination capacity during the COVID-19 pandemic emergency response.

Pharmacists provided vaccine access for persons across a wide range of sociodemographic groups.

From an age perspective, the proportion of COVID-19 bivalent doses administered by pharmacies ranged from 5.9% among children aged six months–4 years to 70.6% among adults aged 18–49 years.

Among racial and ethnic groups (Hispanic, African American, Native Hawaiian, or Asian persons), about 45% of COVID-19 bivalent vaccine doses were administered by pharmacists.

Known as trusted healthcare providers, pharmacists could serve as a model to address vaccination services' needs for routine vaccines and, in future responses to vaccine-preventable disease emergencies, wrote the CDC.

The CDC's support will be mutually beneficial as pharmacists deliver newer COVID-19 in conjunction with flu shots to increase overall uptake this fall season.

Silvia Taylor, Executive Vice President, Chief Corporate Affairs, and Advocacy Officer, Novavax, shared her perspective with Precision Vaccination News on April 8, 2024, "More than ever, we believe that increasing vaccination rates needs to be addressed at multiple levels.

"At the local level, pharmacists are playing an increasingly critical role in keeping our local communities protected from COVID."

"At the national level, public health authorities, like the CDC, are vital to providing guidance and recommendations to inform the healthcare ecosystem of evolving best practices."

"Just last week, at the World Vaccine Congress, CDC Director Mandy Cohen reiterated the ongoing need to raise awareness of the importance of vaccination."

"At Novavax, we support this important public health need."

"We cannot let our guard down; we need to partner across all stakeholders - including government, healthcare practitioners, academia, and industry - to find trusted messengers and messaging that can help to educate the public on why COVID vaccination is important and what vaccine options are available."

From a financial perspective, the CDC's Bridge Access Program, which ends by December 31, 2024, offers free COVID-19 vaccines to adults without health insurance and adults whose insurance does not cover all COVID-19 vaccine costs.

Additionally, numerous programs help fund the cost of influenza vaccinations for children and adults during the 2024-2025 flu season.

Sub Title:

Pharmacies delivered both protein based and mRNA COVID-19 vaccines in 2023

References:

Federal Retail Pharmacy Program Contributions to Bivalent mRNA COVID-19 Vaccinations

Bridge Access Program provides free COVID-19 vaccines

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US CDC 2024

Pharmacies Offer Protein-Based COVID-19 Vaccine Where Needed

Karen McClorey Hackett — Tue, 26 Mar 2024 17:01:25 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

During the recent pandemic, the U.S. government made an important decision to allow pharmacists to work with healthcare providers to increase access to vaccinations, especially in areas that lacked sufficient medical professionals.

This decision has proved valuable, as it is now facilitating the delivery of new COVID-19 vaccines in areas reporting increased hospitalizations in March 2024.

Nationally, the U.S. CDC's wastewater monitoring system indicates SARS-CoV-2 activity level is currently low.

However, the number of new COVID-19 hospital admissions in the past few weeks has been in small markets.

To reach people in these markets, the CDC renewed contracts with community pharmacies through the Increasing Community Access to Testing contract to provide free COVID-19 vaccines in the U.S.

The CDC's Bridge Access Program also offers free COVID-19 vaccines to adults without health insurance and adults whose insurance does not cover all COVID-19 vaccine costs.

According to John Trizzino, Novavax Inc.'s Chief Operating Officer, pharmacists play a crucial role in the decision-making process for COVID-19 vaccination.

In an interview with Precision Vaccination News on March 22, 2024, Mr. Trizzino stated that pharmacists are concerned and caring healthcare providers—the primary educators on 'main street'—who can explain the vaccination options available and the potential need for booster vaccinations, especially when COVID-19 hospitalizations are at their peak in a local market.

Trizzzino's perspective was that throughout the recent pandemic, pharmacists are part of the healthcare provider ecosystem that can help to ensure each person's immunization needs are covered, while the role of companies like Novavax is to make sure these vaccine options are safe and effective.

Pharmacies are now delivering more vaccinations than any other healthcare provider group. I believe pharmacies are a great place to get vaccines because a healthcare professional administers the vaccine.

Overall, pharmacies are a good opportunity for people to be reminded about their vaccinations and their vaccination schedule.

From an availability perspective, the protein-based Novavax COVID‑19 Vaccine, Adjuvanted, is offered at select pharmacy locations, such as Publix, CVS, Rite AID, and Costco.

The U.S. FDA has authorized Novavax's Nuvaxovid™ XBB.1.5 vaccine, one of the thirteen COVID-19 vaccines the World Health Organization listed for 2024.

On March 11, 2024, Canada's National Advisory Committee on Immunization published guidance on using the Nuvaxovid vaccine in Canada. The recommendations state that Nuvaxovid XBB.1.5 can be used in unvaccinated or previously vaccinated individuals aged 12 years and older.

Sub Title:

Wastewater detection identifies COVID-19 locations in March 2024

References:

National Wastewater Surveillance System

COVID-19 Wastewater Monitoring Data

Novavax COVID‑19 Vaccine, Adjuvanted is also available at pharmacy retailers in 2024

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Thursday, March 28, 2024 - 22:45

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CDC United States COVID-19 Hospitalizations March 2024

17% of Canadians Vaccinated with Updated COVID-19

Donald Hackett — Mon, 11 Mar 2024 20:48:33 +0000

Reviewer:

Robert Carlson, MD

The Honourable Mark Holland, Canada's Minister of Health, issued a statement today marking the fourth National Day of Observance for COVID-19.

'Today's landscape is different than it was during the pandemic. COVID-19 vaccines and treatments are now more accessible to people in Canada, making it easier for everyone to protect themselves and their families from serious illness.'

Also, on March 11, 2024, Canada's National Advisory Committee on Immunization released updated guidance regarding the use of Nuvaxovid™ XBB.1.5, a subunit COVID-19 vaccine produced by Novavax Inc.

According to the committee's latest recommendations, announced on March 11, 2024, Novavax Inc.'s protein-based Nuvaxovid XBB.1.5 can be administered to individuals aged 12 and older, regardless of whether they have previously been vaccinated.

This recommendation supports efforts to provide greater access to a non-mRNA protein-based COVID-19 vaccine option and could help achieve improved immunization rates in Canada.

COVID-19 vaccinations began in Canada on December 14, 2020.

As of February 25, 2024, about 17% of Canadians had received an XBB.1.5 vaccine.

The Public Health Agency of Canada has distributed the protein-based vaccine across the regions, and provincial public health programs can advise on specific availabilities.

Two messenger ribonucleic acid (mRNA)-based COVID-19 vaccines remain available in Canada.

Data from clinical trials continue to show broad neutralization responses to currently circulating forward-drift variants, including JN.1 and JN.,4 for our protein-based non-mRNA COVID-19 vaccine while maintaining a favorable side effect profile. Novavax says peer-reviewed effectiveness data is being published to show how immune responses in clinical trials translate into COVID-19 prevention in the real world.

Sub Title:

Canada expands Novavax non-mRNA protein-based COVID-19 vaccine option

References:

National Advisory Committee on Immunization (NACI) Updated guidance on the use of protein subunit COVID19 vaccine (Novavax Nuvax

Canada data: March 8, 2024 with data up to and including February 25, 2024.

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Health Canada data March 2024