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Pfizer/BioNTech Seek Nod for Emergency Use of COVID-19 Vaccine
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Pfizer, Inc. (PFE - Free Report) and its Germany-based partner, BioNTech (BNTX - Free Report) submitted a request to the FDA to grant emergency use authorization (EUA) to their mRNA-based coronavirus vaccine candidate, BNT162b2.
Pfizer sounded confident that it can begin distributing the vaccine within hours of being granted EUA. It believes it can start vaccinating high-risk populations by end of December if granted EUA.
In addition, the companies have initiated rolling submissions with regulatory agencies in Australia, Canada, Europe, Japan and the U.K.
Pfizer’s stock has declined 6.8% this year compared with 0.2% decrease for the industry.
BioNTech’s shares are up 214.3% this year against the industry’s decline of 1.3%.
Final data from a phase III study on BNT162b2, announced last week, showed that the candidate was 95% effective in preventing COVID-19. The final efficacy analysis of data came a week after interim results showed the vaccine was more than 90% effective. The vaccine proved effective across all age groups with the efficacy percentage in adults 65 years and older being over 94%. No serious side effects were observed in the studies.
The large global phase III study enrolled 43,661 participants with diverse backgrounds and the studies were conducted in the United States, Germany, Turkey, South Africa, Brazil and Argentina.
Pfizer and BioNTech selected BNT162b2, out of four mRNA-based coronavirus vaccine candidates, for late-stage development as it demonstrated better results in early-stage studies. They began global phase III development in July.
Pfizer plans to manufacture up to 50 million doses by the end of this year, if approval is received and potentially up to 1.3 billion doses by the end of 2021.
Last week, rival coronavirus vaccine maker, Moderna (MRNA - Free Report) released first interim data from a phase III study on its coronavirus vaccine candidate, mRNA-1273, which uses the same mRNA-based technology as Pfizer/BioNTech. The phase III COVE study on mRNA-1273 demonstrated a vaccine efficacy of 94.5%. Moderna plans to file an EUA to the FDA in the coming weeks,
However, Moderna says its vaccine can remain stable at standard refrigerator temperatures (2°-8°C) for 30 days while Pfizer’s vaccine needs to be stored at extremely low temperatures (-70°C±10°C) for up to 15 days. Once thawed, Pfizer’s vaccine can stay in standard refrigerator temperatures (2°-8°C) for up to 5 days.
Though Moderna probably has distributional advantage over Pfizer because of the latter’s extremely cold storage requirements, both Pfizer and Moderna’s vaccine candidates look promising.
There is an alarming rise in the number of cases of COVID-19 globally and stricter restrictions are being imposed in countries like the United States and Japan. The need of a COVID-19 vaccine is rising with each passing day. J&J’s (JNJ - Free Report) and AstraZeneca/Oxford University's COVID-19 vaccines are also in late-stage development
Meanwhile, the FDA has scheduled an advisory committee meeting on Dec 10 to discuss Pfizer/BioNTech’s EUA. FDA Commissioner Stephen M. Hahn has promised a transparent evaluation process in a “a thorough and science-based manner”. He went on to say that the FDA will review the EUA as quickly as possible.
The need to be transparent and discuss the data with the public might be to encourage the 42% of Americans who have voted that they will not take the vaccine to take the shots.
Meanwhile, Dr. Moncef Slaoui, chief of Operation Warp Speed, said to CNBC, that the vaccine can be distributed across the United States as soon as the FDA grants EUA.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Pfizer/BioNTech Seek Nod for Emergency Use of COVID-19 Vaccine
Pfizer, Inc. (PFE - Free Report) and its Germany-based partner, BioNTech (BNTX - Free Report) submitted a request to the FDA to grant emergency use authorization (EUA) to their mRNA-based coronavirus vaccine candidate, BNT162b2.
Pfizer sounded confident that it can begin distributing the vaccine within hours of being granted EUA. It believes it can start vaccinating high-risk populations by end of December if granted EUA.
In addition, the companies have initiated rolling submissions with regulatory agencies in Australia, Canada, Europe, Japan and the U.K.
Pfizer’s stock has declined 6.8% this year compared with 0.2% decrease for the industry.
BioNTech’s shares are up 214.3% this year against the industry’s decline of 1.3%.
Final data from a phase III study on BNT162b2, announced last week, showed that the candidate was 95% effective in preventing COVID-19. The final efficacy analysis of data came a week after interim results showed the vaccine was more than 90% effective. The vaccine proved effective across all age groups with the efficacy percentage in adults 65 years and older being over 94%. No serious side effects were observed in the studies.
The large global phase III study enrolled 43,661 participants with diverse backgrounds and the studies were conducted in the United States, Germany, Turkey, South Africa, Brazil and Argentina.
Pfizer and BioNTech selected BNT162b2, out of four mRNA-based coronavirus vaccine candidates, for late-stage development as it demonstrated better results in early-stage studies. They began global phase III development in July.
Pfizer plans to manufacture up to 50 million doses by the end of this year, if approval is received and potentially up to 1.3 billion doses by the end of 2021.
Last week, rival coronavirus vaccine maker, Moderna (MRNA - Free Report) released first interim data from a phase III study on its coronavirus vaccine candidate, mRNA-1273, which uses the same mRNA-based technology as Pfizer/BioNTech. The phase III COVE study on mRNA-1273 demonstrated a vaccine efficacy of 94.5%. Moderna plans to file an EUA to the FDA in the coming weeks,
However, Moderna says its vaccine can remain stable at standard refrigerator temperatures (2°-8°C) for 30 days while Pfizer’s vaccine needs to be stored at extremely low temperatures (-70°C±10°C) for up to 15 days. Once thawed, Pfizer’s vaccine can stay in standard refrigerator temperatures (2°-8°C) for up to 5 days.
Though Moderna probably has distributional advantage over Pfizer because of the latter’s extremely cold storage requirements, both Pfizer and Moderna’s vaccine candidates look promising.
There is an alarming rise in the number of cases of COVID-19 globally and stricter restrictions are being imposed in countries like the United States and Japan. The need of a COVID-19 vaccine is rising with each passing day. J&J’s (JNJ - Free Report) and AstraZeneca/Oxford University's COVID-19 vaccines are also in late-stage development
Meanwhile, the FDA has scheduled an advisory committee meeting on Dec 10 to discuss Pfizer/BioNTech’s EUA. FDA Commissioner Stephen M. Hahn has promised a transparent evaluation process in a “a thorough and science-based manner”. He went on to say that the FDA will review the EUA as quickly as possible.
The need to be transparent and discuss the data with the public might be to encourage the 42% of Americans who have voted that they will not take the vaccine to take the shots.
Meanwhile, Dr. Moncef Slaoui, chief of Operation Warp Speed, said to CNBC, that the vaccine can be distributed across the United States as soon as the FDA grants EUA.
Both Pfizer and BioNTech carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>