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Pfizer/BioNTech COVID-19 Vaccine Gets FDA Panel's Backing

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Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-4 recommending that the FDA grant emergency use authorization (EUA) to their mRNA-based coronavirus vaccine candidate, BNT162b2. There was one absentation. 

The recommendation was based on data from a phase III study, announced last month, which showed that BNT162b2, a two-shot vaccine, was 95% effective in preventing COVID-19 after two doses were given three weeks apart. The study has enrolled more than 44,000 participants across clinical sites in the United States, Germany, Turkey, South Africa, Brazil and Argentina with most of them having administered the second shot of the vaccine. The press release said that the Data Monitoring Committee for the study did not report any serious safety concerns related to the vaccine shot.

The FDA should give its decision in a few days’ time. Although the FDA is not bound to follow an advisory committee’s recommendation, it usually follows their opinion. Vaccinations are expected to begin almost immediately after the FDA gives the green signal.

Pfizer/BioNTech had filed the EUA on Nov 20. BNT162b2 was approved for emergency use in United Kingdom and Bahrain earlier this month and in Canada on Wednesday. Meanwhile, the companies have also filed for emergency use in EU and India. In addition, the companies have initiated rolling submissions with regulatory agencies in Australia, Canada, and Japan.

On Wednesday, the FDA issued some briefing documents ahead of the advisory committee meeting. The documents mentioned some side effects related to Bell’s palsy, a form of temporary facial paralysis, that cropped up in the phase III study. Also, concerns have been raised about vaccinating people with severe allergies, following two recent cases in the UK. Nonetheless, the committee found that the benefits of the vaccine outweighed the risks for adults 16 years of age and older, instigating the majority vote.

Pfizer’s stock is up 6.5% this year so far compared with 4.8% increase for the industry.

 

BioNTech’s shares are up 282.4% in the said time frame compared with the industry’s increase of 5.9%.

 

 

Pfizer/BioNTech’s close competitor is Moderna (MRNA - Free Report) , which has also applied for emergency use in the United States and EU for its coronavirus vaccine candidate, mRNA-1273, which uses the same mRNA-based technology as Pfizer/BioNTech. Moderna’s candidate achieved efficacy rate of 94.1% in primary efficacy analysis. An FDA committee is due to review Moderna’s vaccine on Dec 17.

Meanwhile, AstraZeneca (AZN - Free Report) /Oxford University’s potential COVID-19 vaccine candidate, AZD1222 was, on an average, about 70% effective in preventing COVID-19, per interim data released from late-stage studies.J&J’s COVID-19 vaccine is also in late-stage development and the company should release data soon.

While Pfizer has a Zacks Rank #3 (Hold), BioNTech has a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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