Pfizer, Inc. ( PFE Quick Quote PFE - Free Report) and its Germany-based partner, BioNTech’s ( BNTX Quick Quote BNTX - Free Report) final data from a phase III study on their mRNA-based coronavirus vaccine candidate, BNT162b2, showed that the candidate was 95% effective in preventing COVID-19.
The final efficacy analysis of data comes a week after interim results showed the vaccine was more than 90% effective.
BNT162b2 met all of the study’s primary efficacy endpoints. The efficacy was achieved in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective). The vaccine was given in two shots, the second dose given three weeks after the first. The data showed that protection from COVID-19 began 28 days after the first dose or seven days after the second dose was administered. 170 participants in the study were infected with COVID-19 with 162 in the group and 8 in the BNT162b2 vaccinated group. Last week, Pfizer had said it will release the final data after 164 participants are infected with COVID-19.
Importantly the final analyses identified 10 severe cases of COVID-19, with nine occurring in the placebo group and one in the BNT162b2 group. No serious safety concerns have been observed to date. The only major side effects reported were headaches and fatigue.
The vaccine proved effective across all age groups with the efficacy percentage in adults 65 years and older being over 94%. Full results from the study are expected to be published soon.
The large global phase III study enrolled 46,661 participants with diverse backgrounds of which 41,135 participants were given a second dose of the vaccine as of Nov 13. The studies were conducted in the United States, Germany, Turkey, South Africa, Brazil and Argentina.
For emergency use authorization (EUA) in the United States for a potential COVID-19 vaccine, the FDA requires companies to provide two months of safety data on half of the trial participants, after the final dose of the vaccine is administered. Pfizer says that it has now reached this safety milestone and expects to file for EUA soon and also submit the data to other global regulatory authorities.
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.
This week rival coronavirus vaccine maker,
Moderna ( MRNA Quick Quote MRNA - Free Report) also 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%. In Moderna’s study, 95 participants were infected with COVID-19. Importantly the first analyses of COVE study identified 11 severe cases of COVID-19 all of which occurred in the placebo group and none in the mRNA-1273 group. Moderna plans to file an EUA to the FDA in the coming weeks,
So now we have two have two very effective vaccine candidates, which are just few days away from filing for EUA.
However, Moderna says its vaccine can remain stable at standard refrigerator temperatures (2°-8°C) for 30 days while Pfizer’s vaccine is expected to be stored at extremely low temperatures (-70°C±10°C) for it to be used for a longer time. This logistical issue could give Moderna’s vaccine a distributional advantage over Pfizer’s. However, Pfizer has the advantage of huge manufacturing capacity as four of its manufacturing facilities in the United States and BioNTech’s Germany facility will supply the vaccine globally. Meanwhile, Moderna has signed a manufacturing deal with Lonza and Rovi as it does not have enough capacity of its own to manufacture the vaccine. Pfizer however sounded confident that its existing cold-chain infrastructure is good enough to distribute the vaccine globally
Vaccines of both Pfizer/BioNTech and Moderna have demonstrated high end efficacy and are better than investor expectations. They have set the bar quite high for COVID-19 vaccine makers like
AstraZeneca (/Oxford University, J&J, Sanofi/Glaxo and others who are using other technologies/platforms for their vaccines. AZN Quick Quote AZN - Free Report)
Both Pfizer and BioNTech carry a Zacks Rank #3 (Hold). You can see
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