Pfizer and BioNTech complete European submission for omicron-adapted COVID vaccine

Pfizer and BioNTech today announced they submitted to the European Medicines Agency (EMA) for an omicron-adapted bivalent COVID-19 vaccine candidate based on the BA.1 sub-lineage.

The application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to develop an omicron-adapted bivalent vaccine candidate to address the spread of SARS-CoV-2.

Pfizer recently announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the omicron-adapted bivalent vaccine candidate had a superior immune response against omicron BA.1 as compared to its current COVID-19 vaccine. The bivalent vaccine candidate was well-tolerated with a favorable safety profile.

Pfizer and BioNTech previously shared the data with the FDA to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency.

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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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Three doses of Pfizer-BioNTech vaccine neutralized Omicron variant in the lab

Pfizer (NYSE:PFE) and BioNTech SE (NSDQ:BNTX) have announced that their vaccine remains effective against the Omicron variant (B.1.1.529 lineage) of SARS-CoV-2 in early lab studies.

Two doses of the vaccine significantly reduced neutralization titers, while three neutralized the variant.

The lab studies showed that three doses of the BNT162b2 vaccine were similar in efficacy against Omicron as two doses were against the wild-type SARS-CoV-2 spike protein.

Pfizer and BioNTech indicated that two doses of the BNT162b2 are likely insufficient to prevent infection from the Omicron variant. However, the companies still expect that two doses of the vaccine will be effective at protecting against severe disease related to the Omicron variant.

Early evidence suggests that Omicron may offer less of a risk of severe disease than the Delta variant, which continues to dominate the U.S.

“Although two doses of the vaccine may still offer protection agains…

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Study estimates Pfizer COVID-19 vaccine is 78% effective in pregnant women

A retrospective study published in JAMA concluded that the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) offered statistically significant protection against SARS-CoV-2 infection.

The pivotal trial Pfizer used to win emergency use authorization for the vaccine excluded pregnant women. COVID-19, however, increases the risk of pregnancy-related complications — particularly in the third trimester.

To determine how the vaccine performs in pregnant women, researchers in Israel tracked 7,530 vaccinated and 7,530 unvaccinated expectant mothers. They counted 118 COVID-19 infections in the vaccinated group and 202 in the control group. Researchers recruited volunteers from Maccabi Healthcare Services (Tel Aviv).

Among the two groups of women with PCR-confirmed COVID-19 infections, between 83% and 84% were symptomatic.

Some 68 patients receiving the vaccine complained of adverse events. None of them, however, were severe.

The resea…

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Pfizer to seek to expand COVID-19 vaccine EUA to children aged 5 to 11

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the U.S. emergency use authorization (EUA) for their COVID-19 vaccine to include children aged five to 11.  

The companies plan on filing paperwork for the expanded EUA over the coming months. “We are planning for emergency use authorization submission for [children aged five to 11] in September or October of this year, and the [two-to-five-year-old] group to follow soon thereafter,” Alejandra Gurtman, MD, Pfizer’s vice president of vaccine clinical research and development, said during a virtual symposium.

FDA has already authorized the vaccine for people 12 and older. 

Pfizer’s Phase 1/2/3 study testing vaccine safety and efficacy in children has enrolled approximately 4,500 participants aged six months to 11 years old. Some 90 clinical trial sites in the U.S., Poland, Spain and Finland are taking part in the trial. 

The Phase 1/2/3 trial involving children aged six months to 1…

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U.S. buys 200 million more Moderna vaccine doses for potential boosters and use in children

Health experts remain divided over the need for COVID-19 vaccine boosters in the coming months, but the U.S. government is preparing for that possibility by purchasing 200 million additional doses of the COVID-19 vaccine from Moderna (NSDQ:MRNA).

The purchase of additional doses will also enable the U.S. government to inoculate children aged 12 to 17 in coming months, assuming FDA authorizes that use. Two doses of the vaccine were 100% effective in that age group, according to a recent Phase 2/3 trial.

In May, FDA amended its EUA for the Pfizer-BioNTech vaccine to include adolescents aged 12 to 15.

The U.S. has committed to buying 500 million doses of Moderna’s vaccine to date. The company expects to deliver 110 million doses in the fourth quarter of 2021 and another 90 million in the first quarter of 2022.

To date, Moderna has provided 217 million doses to the U.S.

The NIH has launched a clinical trial involving fully vaccinated participan…

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Pfizer expands COVID-19 vaccine trial involving children under 12

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

In related news, Pfizer and BioNTech must contend with concerns that their BNT162b2 could be linked to myocarditis in adolescents.

[Related: 50 of 2020’s best-selling pharmaceuticals]

A recently published preprint in the journal Pediatrics describes seven male adolescents who developed myocarditis after receiving the vaccine. All seven pa…

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