It’s a historic day for science and for us, said Albert Bourla, chairman and CEO of Pfizer, after the two companies filed for marketing authorization for their vaccine on Friday.
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According to the two companies’ projections, more than 50 million doses could thus be produced in 2020 alone. By the end of 2021, that figure will rise to more than 1.3 billion, Bourla said.
The announcement had been expected for several days, after the publication of the results of the clinical trial carried out since July on 44,000 volunteers in multiple countries, and according to which the vaccine would be 95% effective to prevent COVID-19 without serious side effects.
Demand in the United States represents a critical step in our quest for a COVID-19 vaccine for the world, and we now have a more complete picture of the efficacy and safety of our vaccine, which gives us confidence in its potential.
The vaccine has also been continuously evaluated for weeks by the European Union, Australia, Japan, the United Kingdom and Canada, where the government of Justin Trudeau has reserved 76 million doses of this candidate vaccine.
Companies will be ready to distribute the vaccine within hours of authorization, they said in their statement.
The FDA has not said how long it will take to review the data, but the US government expects a green light in the first two weeks of December.
Europe could follow quickly: from the second half of December for the European Medicines Agency, according to Commission President Ursula von der Leyen. Another vaccine – this one from the American company Moderna –, also effective, is followed very closely by Pfizer.
Donald Trump’s administration already plans to vaccinate 20 million people in December, and then 25 to 30 million people per month thereafter.
A vaccine developed at high speed
The speed of these procedures is unprecedented in the history of vaccines. Authorized vaccines have taken eight years of development on average over the past decade in the United States.
BioNTech only offered its groundbreaking messenger RNA technology to Pfizer in March as the world went through its first lockdown.
The first volunteer received the vaccine on April 23 in Germany, in the first phase of the trials. The third phase, the last, began on July 27 and has since recruited 44,000 participants on several continents.
Half of these volunteers received a placebo, and the other half the experimental vaccine, without knowing which one. They lived their lives normally, with the same cautionary advice as the rest of the population.
Gradually, with the outbreak of the pandemic in the United States in the fall, the number of COVID-19 cases jumped in the placebo group, but not in the vaccinated group.
Of 170 cases among the participants, 162 were in the placebo group and 8 in the treated group, according to statements from the manufacturers. The statistic is clear: a vaccinated person was 95% less likely to catch COVID-19 than an unvaccinated person.
Better still, the vaccine seems effective in preventing severe forms of the disease, and it would be as effective in young people as in those over 65.
As a first step, the FDA will grant an emergency use authorization; a conditional green light, linked to the health emergency, and probably restricted to certain groups.