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Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis

Analysis evaluated 94 confirmed cases of COVID-19 in trial participants

Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected

Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November

Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

the staff of the Ridgewood blog

NEW YORK & MAINZ, GERMANY , Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.

After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”

“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at

Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.

Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.


  1. Curious timing….

    Headlines page 1, restractions page 24…?

  2. a vaccine for covid that 99.49 % of the people recover from?

  3. lets get the party started

  4. too bad new jersey drove most of Pfizer out of the state

  5. Biden scores first win of his presidency 🙂 . Be prepared for him to make it mandatory to the whole population.

  6. Biden had nothing to do w this. If he wins, he will be steamed rolled by the progressive left but nothing will get done. GOP killing it in house elections and will maintain Senate. 2 yrs of getting nothing done then GOP controls house


  7. Thank you President Trump.
    Thanks for motivating the drug companies.
    Thank you for Operation Warp Speed.

    Thank God you were in office, otherwise we’d be waiting 3-5 more years for a vaccine.

    Another WIN for the TRUMP presidency.

  8. Great understanding of our systems Anonymous #5.
    All things bad (R)
    All things good (D)
    By the way. His presidency starts January 2021.

  9. Why didnt they announce this last week before the election

  10. Thank You President Trump!
    The same Democrats who were leaving the country when he became president can allow the rest of us to get the vaccine first. I do recall Harris and a bunch of other Dems saying if it comes out under Trump she will not take it. Good I will

  11. This media is so corrupt. This was totally trumps administration pushing the drug companies.

  12. “GOP killing it in house elections and will maintain Senate.”

    So….you accept the results of the house and sentate, but not the president? They’re the same ballots…..

  13. They need to inject this vaccine into all elected and unelected officials, starting with Pfizer top management
    Then we monitor them for 10 years.
    Then we decide

  14. “So….you accept the results of the house and sentate, but not the president? They’re the same ballots…..”

    This supports the cheating narrative….

    GOP big pickups in house and no losses in Senate, but mysteriously Hundreds of Thousands of Biden votes “appear” after vote counting pauses overnight and only in battle ground states.

    Doesn’t pass the smell test…

  15. Trump was Screwed from day one.
    And everybody knows it. Damn media .

  16. Stacy Abrams has promised to deliver the 2 remaining senate seats in GA. Consider it done. Get ready for a total domination of democrats with devastating consequences. Those republicans celebrating the “progress’ in congress and maintain the senate are simply dumb. If they haven’t realized what the left is capable of doing then we really deserve to be punished.

    1. “it aint over till its over “

  17. Right , The dirt will be coming out real soon.

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