American drug giant Pfizer along with its German partner BioNTech confirmed on November 18, 2020 that they have concluded the phase 3 study of their COVID-19 vaccine candidate and it meets all primary efficacy endpoints. Pfizer's vaccine was found to be 95 percent effective after the last-stage trial and showed no serious side effects on older people.
The final efficacy analysis of the drugmaker's ongoing Phase 3 study showed that their mRNA-based COVID-19 vaccine candidate meets all of the study’s primary efficacy endpoints.
The analysis of the data indicated a vaccine efficacy rate of 95 percent in participants without prior SARS-CoV-2 infection, which was the first primary objective and in participants with and without prior COVID-19 infection, which was the second primary objective.
BREAKING: We are proud to announce, along with @BioNTech_Group, that the Phase 3 study of our #COVID19 vaccine candidate has met all primary efficacy endpoints.
— Pfizer Inc. (@pfizer) November 18, 2020
Key Highlights
•As per the primary efficacy analysis, Pfizer's BNT162b2 COVID-19 vaccine candidate was found to be 95% effective against COVID-19 beginning 28 days after the first dose.
•The analysis is based on an evaluation of 170 confirmed COVID-19 cases, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 vaccine group.
•The vaccine's efficacy was found to be consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults aged above 65 years was over 94 percent.
•The trial has achieved the safety data milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).
•The data reveals that the vaccine was well received across all populations with over 43,000 participants enrolled and no serious safety concerns were observed.
Pfizer vaccine side-effects |
| The most common serious or Grade 3 adverse side-effect was fatigue with 3.8 percent of volunteers reporting tiredness after they took the second dose. Besides this, 2 percent of volunteers reported headaches after the second dose. The older adults reported fewer and milder side effects |
What now?
Pfizer and BioNTech now plan to submit a proposal for Emergency Use Authorization to the US Food and Drug Administration. The companies will also share data with other regulatory agencies around the globe.
When will Pfizer's COVID vaccine be ready for use?
The companies aim to produce up to 50 million vaccine doses globally before the end of 2020 and up to 1.3 billion doses by the end of 2021. Pfizer aims to use its vast expertise and existing cold-chain infrastructure to ensure distribution and delivery of the vaccine around the globe. With this fast pace of vaccine development, the COVID-19 vaccine is likely to be ready for delivery by the beginning of 2021.
Background
Pfizer and the German biotechnology firm BioNTech had last week published data stating that their vaccine was found to be more than 90 percent effective.
Pfizer's latest study findings follow the announcement by US biotech company Moderna, which had released preliminary data of its late-stage clinical trials for its vaccine on November 16, 2020, which stated that its vaccine candidate has proven to be 94.5 percent effective.
Also Read: Moderna says its COVID vaccine is 94.5% effective
Vaccine Storage |
| •As per reports, Pfizer's COVID vaccine candidate must be stored at minus 94 degrees Fahrenheit, colder than any other vaccine in development. •Once it receives the emergency use authorization, Pfizer will ship the vaccine in special boxes of 1,000 to 5,000 doses that will be stuffed with dry ice and equipped with GPS-enabled sensors. •Moderna's vaccine must also be stored in a freezer but at minus 4 degrees Fahrenheit. |
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