FDA advisors unanimously back Moderna and Pfizer COVID-19 vaccines in young children

An FDA panel voted 21 to 0 to authorize the Pfizer/BioNTech and Moderna COVID-19 vaccines in children between the ages of 6 months and 4 years of age.

Children under the age of 5 constitute the only age group that has not been eligible to be vaccinated against COVID-19.

“I know there are a lot of very relieved parents,” said Dr. Jon Portnoy, a voting member of the Vaccines and Related Biological Products Advisory (VRBPAC) panel. “I understand why parents are very nervous and fearful of doing normal activities, especially if their child actually catches COVID.”

The potential availability of two COVID-19 vaccines for young children “will certainly alleviate a lot of [parents’] concerns,” he added.

VRBPAC member Dr. Ofer Levy emphasized the importance of choice for parents with young children.

“They can partner with their pediatrician to make a decision,” Levy said. Vaccines are a vital tool for fighting COVID-19, especially in communiti…

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Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children

Pfizer-BioNTech COVID-19 vaccine. [Image courtesy of Wikimedia Commons]

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data supports a third dose of their COVID-19 vaccine in young children.

Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong immune response and a favorable safety profile similar to placebo in children aged six months to under five years old.

In the trial, 1,678 children received a third dose of the vaccine at least two months after second dose, while omicron was the predominant variant. Non-inferiority was met for both the 6-24 month-old population and the 2-under 5-year-old population for both primary endpoints, with the vaccine well tolerated, leading to no new safety signals.

Vaccine efficacy (a secondary endpoint) registered at 80.…

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NIH to study allergic reactions to COVID-19 mRNA vaccine

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Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines.

The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants who experienced a mild or moderate systemic allergic reaction to either the Pfizer/BioNTech or Moderna COVID-19 vaccines.

People who developed a severe allergic reaction to a first dose of a COVID-19 mRNA vaccine are not eligible to enroll.

According to a news release, participants will receive a second dose of the vaccine as inpatients under carefully controlled conditions at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. NIAID’s Laboratory of Allergic Diseases’ Dr. Pamela A. Guerrerio…

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Pfizer plans to share data on fourth dose of COVID-19 vaccine with FDA

COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg.

The company and its partner BioNTech (Nasdaq: BNTX) are also developing an omicron-specific version of the vaccine.

Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose of its original COVID-19 vaccine and a new formulation intended to protect against multiple SARS-CoV-2 variants.

Data related to the omicron-specific version are not yet available.

Pfizer also said that clinical trial data involving children under 5 who received three doses of its COVID-19 vaccine would be available in April.

A small Israeli study summarized in Nature last month indicated that a fourth vaccine dose provides a modest increase in antibodies.

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Pfizer and BioNTech set their sights on developing mRNA-based shingles vaccine

Pfizer Inc. (NYSE:PFE) and mRNA vaccine specialist BioNTech SE (NSDQ:BNTX) will collaborate to develop an mRNA-based vaccine to prevent the herpes zoster virus (shingles).

Roughly one million people in the U.S. get shingles each year, according to the CDC.

Currently, the two-dose Shingrix shingles vaccine from GSK (NYSE:GSK) is the only such product available in the U.S. market. Shingrix won FDA approval in 2017.

In 2020, Shingrix generated £1.99 billion ($2.55 billion) in sales internationally.

Pfizer and BioNTech began working together on an mRNA vaccine for influenza in 2018. Two years later, the two companies began work on a COVID-19 vaccine, which has since become one of the bestselling pharmaceutical products in the world.

The shingles mRNA vaccine collaboration will bring together Pfizer’s antigen technology and BioNTech’s mRNA platform.

The two companies will split development costs and plan on beginning clinical trials in th…

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FDA authorizes expanded use of Pfizer-BioNTech vaccine boosters

With the U.S. facing the biggest surge of COVID-19 infections to date, the FDA has decided to amend the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover adolescents aged 12 to 15 and for some immunocompromised children between the ages of 5 and 11. The agency has also reduced the window between the second and third doses from six to five months. 

“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing in order to effectively fight COVID-19,” said Acting FDA Commissioner Dr. Janet Woodcock.

To arrive at its decision, FDA analyzed real-world data from Israel, including 6,300 individuals between the ages of 12 and 15 who received a booster dose of the BNT162b2 vaccine at least five months after receiving a second dose.  

The authorization for certain immunocompromised child…

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CDC director recommends boosters for more Americans

CDC Director Dr. Rochelle P. Walensky issued guidelines for COVID-19 boosters, clearing the way for tens of millions of U.S. citizens to obtain a third dose of the Pfizer-BioNTech COVID-19 vaccine.

While FDA and the Advisory Committee on Immunization Practices (ACIP) reached broadly similar conclusions regarding booster doses for seniors and high-risk individuals, Walensky went further. A CDC statement also recommends boosters for people 18 to 49 with underlying medical conditions and people 18 to 64 with a high risk of occupational or institutional exposure.

Dr. Rochelle Walensky

The eligible underlying medical conditions range from having a high body mass index and a history of smoking to HIV and cancer.

Walensky said CDC would review data related to the Moderna and J&J vaccines related to their use as boosters. Both companies have released early data suggesting that boosters of their vac…

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Pfizer-BioNTech to provide U.S. with another 200M shots for kids, boosters

Pfizer-BioNTech vaccine [Image courtesy of Wikipedia]

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine.

Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster shots against variants. In a recent CNN interview, President Joe Biden predicted that the government will OK vaccines for young children in the next few months; Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases told a Senate panel that it could be by early winter.

Pfizer and BioNTech expect to deliver the additional doses from October 2021 through April 2022, bringing the total doses purchased by the U.S. government for the American public to…

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Biovac to make and distribute Pfizer-BioNTech COVID-19 vaccine in Africa

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) today announced an agreement with Biovac to manufacture the companies’ COVID-19 vaccine for distribution in Africa.

Cape Town, South Africa-based Biovac will perform manufacturing and distribution activities within Pfizer and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network to aid in distribution within the African Union, according to a news release. The technical transfer, on-site development and equipment installation activities for Biovac will begin immediately.

Pfizer and BioNTech’s global vaccine supply chain and manufacturing network now spans three continents, the companies said, with more than 20 million manufacturing facilities.

They expect Biovac’s Cape Town facility to be incorporated into the COVID-19 vaccine supply chain by the end of 2021, with Biovac slated to obtain drug substance from European facilities. The manufacturing of finished doses will c…

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Biden to promise world 500 million COVID-19 vaccine doses

Pfizer-BioNTech vaccine image courtesy of Wikipedia

President Joe Biden has struck a deal with Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) to provide 500 million COVID-19 vaccine doses to roughly 100 countries over two years.

Biden will announce the plan in the near future at an appearance with Pfizer CEO Dr. Albert Bourla, according to a report from The New York Times.

As COVID-19 cases in the U.S. continue to fall, Biden has faced growing pressure to provide vaccine doses to regions continuing to battle surges in infections.

When boarding Air Force One, Biden confirmed that his administration was making progress with its global vaccine strategy. While hinting at a forthcoming news announcement, he did not offer further information.

Biden has promised to provide 80 million vaccine doses by the end of June.

The U.S. will pay for the COVID-19 doses at cost, according to The New York…

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Exelead makes first precursor batch of Pfizer-BioNTech COVID-19 vaccine

Pharma industry contract manufacturer Exelead recently announced that it has delivered its first precursor batch of Prizer-BioNTech’s COVID-19 vaccine, produced at its recently expanded facility in Indianapolis.

Exelead plans to add 50 jobs to help it meet COVID-19 vaccine demand.

“We are extremely proud to be part of the manufacture of the Pfizer-BioNTech COVID-19 vaccine, knowing our work has the potential to help millions of people,” said Exelead CEO John Rigg said in a news release. “As a leader in complex drug manufacturing, Exelead is committed to leveraging our manufacturing capabilities and years of experience to help support the supply of the Pfizer-BioNTech COVID-19 vaccine and increase the number of doses available.”

Kevin Nepveux, VP of Pfizer Global Supply, added that contract manufacturer support is one way the pharmaceutical giant has ramped up manufacturing capabilities to produce more COVID-19 vaccine doses.

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EU allows Pfizer/BioNTech COVID-19 vaccine to be stored at higher temperatures

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature.

Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures, with preferred storage set in an ultra-low temperature freezer between -80ºC to -60ºC.

As a result of the approval, vials of the vaccine can be stored in all 27 European Union (EU) member states at the updated temperatures as an alternative to the ultra-low requirements, offering flexibility to distribution and inoculation, according to a news release.

“From the beginning our goal was to make our vaccine broadly available to people around the world. This approval…

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