Pfizer confirmed Friday it expects to seek emergency authorization of its experimental vaccine against Covid-19, if it is effective, in the third week of November.

An analysis of the efficacy of the vaccine could be available sooner, the company said in an open letter from its CEO, Albert Bourla, but required safety data will take longer. The timelines included in the letter are not new, based on disclosures the company has previously made about the status of its vaccine effort with the German biotechnology firm BioNTech. But the need for Bourla, who had previously said a vaccine could be available by October, to make a public announcement emphasizes the tense political conditions surrounding the race for a vaccine.

The Food and Drug Administration slightly extended the timeline for any company to file for an emergency use authorization earlier this month when it communicated to companies that it would require two months of safety data to be collected on at least half of the patients in a company’s clinical trial. That, according to the Pfizer CEO’s letter, is now the gating step for the approval of a vaccine.

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Bourla’s letter includes three new details:

— Pfizer and BioNTech will have two months of safety data on half the patients in their 44,000-patient vaccine study in the third week of November, based on current enrollment rates. This would allow the companies to file for an emergency use authorization.

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— The independent data safety monitoring board, a panel of experts monitoring the study, will conduct interim analyses of the effectiveness of the vaccine. This is what originally drove the October timeline.

— Pfizer said that it “will share any conclusive readout” from these interim analyses, be they positive or negative, but that the study will continue until its conclusion.

This last point is unusual. These types of interim analyses are common, but usually are made public only when they result in a trial being stopped because it shows efficacy or a lack of safety. This could mean that the study will continue, with half the patients receiving placebo, after it is known that the vaccine is effective.

Pfizer and BioNTech are likely to have early efficacy data before any other company running a vaccine trial. The study of their vaccine began on the same day as one from Moderna, but is designed in several ways to give an earlier readout. Two other vaccine trials have currently stopped enrolling new patients. Johnson & Johnson paused its vaccine trial earlier this week. AstraZeneca’s vaccine study has been paused in the U.S. for more than a month.

President Trump had previously said that a vaccine could be available by election day, but recently acknowledged this is unlikely.

  • Is the Biden Campaign infiltrating the FDA to stall the process ? This must be researched . A “vaccinegate” scandal may be occurring .

    • Pfizer is operating at the speed of science. The timelines reflect their best estimates of when important milestones could be achieved. Marvin, why don’t you inject bleach and take chloroquine in the meantime?

  • Given the logistical nightmares if not impossibilities involved with distributing this vaccine, let’s hope that other makers can just as quickly develop and produce a safe and successful vaccine that is more usable. Pfizer should have considered this when they designed their product. Others certainly did. Personally, I’ve got my fingers crossed for Johnson & Johnson – a single dose that’s stored at room temperature.

    • “Impossibilities” is a massive overstatement here.

      https://www.dhl.com/content/dam/dhl/global/core/documents/pdf/glo-core-delivering-pandemic-resilience-2020.pdf

      The above study suggests that even with the need to maintain temperatures at -80 degrees Celsius (conservative as highly likely stability testing will see Pfizer eventually move their temperature limit towards Moderna’s given they are both mRNA vaccines) countries housing 2.5bn people would have the means to effectively distribute the vaccine.

      It really isn’t rocket science. Ultra cool freezers for DCs and dry ice loaded chill boxes for air and ground transport to innoculation locations.

      No reason at all why innoculation pop up clinics couldn’t be set up at the thousands upon thousands of regional airport scattered across almost every developed nation on earth.

      As to the other 4.5bn people on earth the Chinese (e.g. sinopharm) appear very close to read outs on inactivated virus vaccine candidates that were tested in Latin America and the middle east). These only require being chilled.

      At the end of the day you don’t need to innoculate everybody to MASSIVELY reduce morbidity / mortality. Innoculate those at highest risk first (elderly, hypertension, diabetes, renal disease, heart disease, auto antibody positive patients) and you’ll drastically reduce your mortality if one assumes a high degree of efficacy against developing severe disease (as opposed to sterilising immunity).

  • A vaccine is urgently needed, so development speed matters – but so does availability and transportability of the vaccine. Pfizers’ needs to be stored & transported at minus 70C, which makes widespread global use logistically unattainable. With masks, distancing, smaller and fewer gatherings (all smart behaviour) time can be less deadly, while a less cumbersome and democratically fairer vaccine gets developed. Being first out of the gate does not mean being the winner of the race.

  • Sorry but the western world really has lost its way when everybody thinks waiting another month to take any action on vaccinating the vulnerable is the correct course of action here (assuming the vaccine has been shown to be efficacious that is).

    Newsflash: 5000+ people are dying of COVID-19 a DAY with the trend now rising again. Tens and tens of thousands more are being severely injured with chronic damage to their lungs, heart, brain, thyroid, kidneys etc A DAY.

    Suicide rates are up, cancer screenings etc are well down. Every day that passes without an effective vaccine is condemning well over 5000 people a day to death and misery.

    Even if you assume the Pfizer vaccine had an undprecedently bad adverse event rate with 1 in 100,000 recipients DYING you could vaccinate the entire global population in that month delay and still have less than HALF the dead than will be caused by allowing the pandemic to spread unchecked without a vaccine for another month. I.e. 70,000 vs 150,000.

    At the very least the FDA should make it clear that they will consider an EUA (assuming efficacy) for the following:
    – healthcare workers with a far higher propensity to catch the disease (and catch a massive innoculum of it) plus be links in transmission chains;
    – those with pre-existing conditions that mean they have far higher risk of mortality. I.e. age > 70, BMI > 30, hypertension, kidney disease, diabetes, heart disease, those with auto antibodies to interferon alpha. Etc

    Come on could we please have sensible EVIDENCE based policy that acknowledges that everything in life has RISK. Take the course of action with LESS risk and reduce morbidity and mortality. Isn’t that what public health agencies are supposed to do.

  • The US has commitment from Pfizer to provide doses for 50 million through 2021. There is the “option” 250 million more. If Moderna is the only other vaccine to receive approval, then how realistic is it to vaccinate the US population by spring 2021?

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