We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pfizer/BioNTech COVID-19 Vaccine Raises New Safety Concerns
Read MoreHide Full Article
The FDA issued some briefing documents ahead of a key advisory committee meeting on Thursday to discuss Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) emergency use authorization (EUA) for their mRNA-based coronavirus vaccine candidate, BNT162b2. 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. This might raise investor concern.
Pfizer/BioNTech had filed the EUA on Nov 20. BNT162b2, a two-shot vaccine, was approved for emergency use in United Kingdom and Bahrain this month and in Canada on Wednesday. Meanwhile, the companies have also filed for emergency use in the United States, EU and India. In addition, the companies have initiated rolling submissions with regulatory agencies in Australia, Canada, and Japan. Vaccine rollouts are expected to be rapid once the countries give the green signal.
Coming back to the briefing documents, they mentioned that the safety data from approximately 38,000 participants suggested a favorable safety profile, with no specific safety concerns identified that would preclude the granting of an EUA. However, among non-serious adverse events, the documents mentioned the numerical imbalance of four cases of Bell’s palsy in the vaccine group compared with no cases in the placebo group. However, it was not clear whether the vaccine shot caused the Bell’s palsy. The incidence of Bell's palsy was not above that expected in the general population, the documents specified.
Final data from a phase III study on BNT162b2, announced last month, showed that the candidate was 95% effective in preventing COVID-19 after two doses were given three weeks apart. However, the latest documents mentioned that the vaccine provides strong protection against COVID-19 even a few days after the first dose was administered. Meanwhile, the vaccine is broadly effective across all age groups, racial and ethnic groups.
Pfizer’s stock is up 7.9% this year so far compared with 4% increase for the industry.
BioNTech’s shares are up 269% in the said time frame compared with the industry’s increase of 7.5%.
The FDA should give its decision soon after the VRBPAC committee’s vote. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting on Thursday to provide recommendations on whether BNT162b2 is effective in preventing COVID-19 and whether the benefits of the vaccine outweigh the risks to allow issuance of EUA.
Though the VRBPAC will surely discuss the concerns raised in the FDA documents about Bell’s palsy, we believe the side effects are not alarming enough for the committee to give a negative vote or for the FDA to not grant an emergency use. However, the side effects may put Pfizer’s vaccine at a disadvantageous position compared to rival vaccines
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).
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year.
These 7 were selected because of their superior potential for immediate breakout.
Image: Bigstock
Pfizer/BioNTech COVID-19 Vaccine Raises New Safety Concerns
The FDA issued some briefing documents ahead of a key advisory committee meeting on Thursday to discuss Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) emergency use authorization (EUA) for their mRNA-based coronavirus vaccine candidate, BNT162b2. 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. This might raise investor concern.
Pfizer/BioNTech had filed the EUA on Nov 20. BNT162b2, a two-shot vaccine, was approved for emergency use in United Kingdom and Bahrain this month and in Canada on Wednesday. Meanwhile, the companies have also filed for emergency use in the United States, EU and India. In addition, the companies have initiated rolling submissions with regulatory agencies in Australia, Canada, and Japan. Vaccine rollouts are expected to be rapid once the countries give the green signal.
Coming back to the briefing documents, they mentioned that the safety data from approximately 38,000 participants suggested a favorable safety profile, with no specific safety concerns identified that would preclude the granting of an EUA. However, among non-serious adverse events, the documents mentioned the numerical imbalance of four cases of Bell’s palsy in the vaccine group compared with no cases in the placebo group. However, it was not clear whether the vaccine shot caused the Bell’s palsy. The incidence of Bell's palsy was not above that expected in the general population, the documents specified.
Final data from a phase III study on BNT162b2, announced last month, showed that the candidate was 95% effective in preventing COVID-19 after two doses were given three weeks apart. However, the latest documents mentioned that the vaccine provides strong protection against COVID-19 even a few days after the first dose was administered. Meanwhile, the vaccine is broadly effective across all age groups, racial and ethnic groups.
Pfizer’s stock is up 7.9% this year so far compared with 4% increase for the industry.
BioNTech’s shares are up 269% in the said time frame compared with the industry’s increase of 7.5%.
The FDA should give its decision soon after the VRBPAC committee’s vote. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting on Thursday to provide recommendations on whether BNT162b2 is effective in preventing COVID-19 and whether the benefits of the vaccine outweigh the risks to allow issuance of EUA.
Though the VRBPAC will surely discuss the concerns raised in the FDA documents about Bell’s palsy, we believe the side effects are not alarming enough for the committee to give a negative vote or for the FDA to not grant an emergency use. However, the side effects may put Pfizer’s vaccine at a disadvantageous position compared to rival vaccines
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.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year.
These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>