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- The first results show initial evidence of ability to prevent Covid-19
- The CEO of the company says it is a fundamental milestone at a time when it is most needed
- Phase 3 trials are still ongoing around the world.
Pfizer said Monday that its experimental Covid-19 vaccine was more than 90% effective, a major victory in the fight against a pandemic that has killed more than a million people, hit the global economy and disrupted daily life.
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Pfizer and German partner BioNTech SE are the first drug manufacturers to publish successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have found no serious safety concerns so far and hope to apply for US authorization this month for emergency use of the vaccine.
If authorized, the number of doses will initially be limited and many questions remain, including how long the vaccine will provide protection. However, the news provides hope that other Covid-19 vaccines in development may also prove effective.
“Today is a great day for science and humanity,” said Albert Bourla, Pfizer president 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 approaching overcapacity and economies struggling to reopen.”
Pfizer hopes to obtain a broad US authorization for the emergency use of the vaccine in people ages 16 to 85. To do so, you will need two months of safety data from about half of the 44,000 study participants, which you expected at the end of this month.
“I’m almost ecstatic,” Bill Gruber, one of Pfizer’s leading vaccine scientists, said in an interview. “This is a great day for public health and for the potential to lift us all out of the circumstances we are in now.”
1.3 billion doses
Pfizer and BioNTech have a $ 1.95 billion contract with the United States government to deliver 100 million doses of vaccines starting this year. They have also reached supply agreements with the European Union, the United Kingdom, Canada and Japan.
To save time, companies started making the vaccine before they knew if it would be effective. They now hope to produce up to 50 million doses, or enough to protect 25 million people this year.
Pfizer said it expects to produce up to 1.3 billion doses of the vaccine in 2021.
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The US pharmaceutical giant said the interim analysis was conducted after 94 trial participants developed Covid-19, examining how many of them had received the vaccine compared to a placebo.
The company did not break down exactly how many of those who became ill received the vaccine. Still, an effectiveness greater than 90% implies that no more than 8 of the 94 people who contracted Covid-19 had received the vaccine, which was administered in two injections approximately three weeks apart.
The efficacy rate is well above the 50% effectiveness required by the US Food and Drug Administration for a coronavirus vaccine.
To confirm the efficacy rate, Pfizer said it would continue the trial until there are 164 cases of Covid-19 among the participants. Given the recent spike in infection rates in the United States, that number could be reached as early as December, Gruber said.
The data has not yet been peer-reviewed or published in a medical journal. Pfizer said it would do it once it has the results of the entire test.
Global career
The global race for a vaccine has seen richer countries forge multi-billion dollar supply deals with pharmaceutical companies such as Pfizer, AstraZeneca Plc and Johnson & Johnson, raising questions about when poorer and middle-income nations will have access. to vaccines.
Dozens of pharmacists and research groups around the world have been racing to develop vaccines against Covid-19, which surpassed 50 million infections on Sunday since the new coronavirus appeared late last year in China.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which is based on synthetic genes that can be generated and manufactured in weeks, and produced at scale faster than conventional vaccines.
Moderna, whose vaccine candidate employs similar technology, is expected to report the results of its large-scale trial later this month.
The mRNA technology is designed to trigger an immune response without using pathogens, such as real virus particles.
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Image Credit: Getty Images
