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Will Americans Get COVID-19 Vaccine Sooner Than Europeans?
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The European Medicines Agency (EMA) acknowledged the receipt of conditional marketing authorization (CMA) of Moderna (MRNA - Free Report) , and Pfizer,Inc. (PFE - Free Report) /BioNTech’s (BNTX - Free Report) COVID-19 vaccine candidates on Tuesday. A CMA allows companies to seek approval for medicines/vaccines that fulfil an unmet medical need based on less complete data than needed.
The agency said that the assessments of the vaccines, Moderna’s mRNA1273 and Pfizer/BioNTech’s BNT162b2 will progress under an accelerated timeline. Both the companies had initiated a rolling submission for their respective candidates much earlier, Pfizer/BioNTech in October and Moderna in mid-November. The formal CMA submissions complete the rolling review process.
The EMA has already reviewed some of the data as part of the rolling review process. If EMA, after reviewing the new data, concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID-19, it may recommend granting a CMA to the vaccines.
The EMA said that its Committee for Human Medicines (CHMP) will review the quality, safety and effectiveness of the vaccine. It will conclude its assessment and give its decision at meetings scheduled on Dec 29 for Pfizer/BioNTech and Jan 12 for Moderna. The European Commission, the EU executive body, will give its final decision days after a recommendation by the EMA.
Both mRNA1273 and BNT162b2 have been effective in preventing COVID-19 in late-state studies and look promising. Moderna’s candidate achieved efficacy rate of 94.1% in primary efficacy analysis. Importantly, it showed 100% effectiveness in preventing severe cases of COVID-19. Pfizer’s BNT162b2, on the other hand, was 95% effective in preventing COVID-19.
Both the companies have also applied for emergency use authorization (EUA) from the FDA for their respective candidates. While Moderna filed for EUA on Monday, Pfizer/BioNTech had filed for the same on Nov 20.
The FDA has scheduled an advisory committee meeting on Dec 10 to discuss Pfizer/BioNTech’s EUA and a similar meeting on Dec 17 to discuss Moderna’s EUA. The FDA should make its decisions soon after the meetings and the vaccines are expected to be launched in December, if approved.
With the EMA scheduling similar meetings at later dates than FDA, it looks like the vaccines might be launched in the United States first. Europeans will be considered lucky if they get the vaccines before year-end. Meanwhile, BNT162b2 got its first approval in the world with U.K. regulatory agency, Medicines & Healthcare Products Regulatory Agency (MHRA) granting it a temporary authorization for emergency use on Wednesday.
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 (JNJ - Free Report) COVID-19 vaccine is also in late-stage development and the company should release data soon.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
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Will Americans Get COVID-19 Vaccine Sooner Than Europeans?
The European Medicines Agency (EMA) acknowledged the receipt of conditional marketing authorization (CMA) of Moderna (MRNA - Free Report) , and Pfizer, Inc. (PFE - Free Report) /BioNTech’s (BNTX - Free Report) COVID-19 vaccine candidates on Tuesday. A CMA allows companies to seek approval for medicines/vaccines that fulfil an unmet medical need based on less complete data than needed.
The agency said that the assessments of the vaccines, Moderna’s mRNA1273 and Pfizer/BioNTech’s BNT162b2 will progress under an accelerated timeline. Both the companies had initiated a rolling submission for their respective candidates much earlier, Pfizer/BioNTech in October and Moderna in mid-November. The formal CMA submissions complete the rolling review process.
The EMA has already reviewed some of the data as part of the rolling review process. If EMA, after reviewing the new data, concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID-19, it may recommend granting a CMA to the vaccines.
The EMA said that its Committee for Human Medicines (CHMP) will review the quality, safety and effectiveness of the vaccine. It will conclude its assessment and give its decision at meetings scheduled on Dec 29 for Pfizer/BioNTech and Jan 12 for Moderna. The European Commission, the EU executive body, will give its final decision days after a recommendation by the EMA.
Both mRNA1273 and BNT162b2 have been effective in preventing COVID-19 in late-state studies and look promising. Moderna’s candidate achieved efficacy rate of 94.1% in primary efficacy analysis. Importantly, it showed 100% effectiveness in preventing severe cases of COVID-19. Pfizer’s BNT162b2, on the other hand, was 95% effective in preventing COVID-19.
Both the companies have also applied for emergency use authorization (EUA) from the FDA for their respective candidates. While Moderna filed for EUA on Monday, Pfizer/BioNTech had filed for the same on Nov 20.
The FDA has scheduled an advisory committee meeting on Dec 10 to discuss Pfizer/BioNTech’s EUA and a similar meeting on Dec 17 to discuss Moderna’s EUA. The FDA should make its decisions soon after the meetings and the vaccines are expected to be launched in December, if approved.
With the EMA scheduling similar meetings at later dates than FDA, it looks like the vaccines might be launched in the United States first. Europeans will be considered lucky if they get the vaccines before year-end. Meanwhile, BNT162b2 got its first approval in the world with U.K. regulatory agency, Medicines & Healthcare Products Regulatory Agency (MHRA) granting it a temporary authorization for emergency use on Wednesday.
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 (JNJ - Free Report) COVID-19 vaccine is also in late-stage development and the company should release data soon.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
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