Pfizer ($PFE) is the first company to release late-stage research results showing that a vaccine candidate shows a very high positive response. Pfizer and German partner BioNTech ($BNTX) now want to discuss the results with global regulatory authorities as soon as possible.
Pfizer climbs up after another milestone
A great start to the week for Pfizer, which announced positive results from a late-stage vaccine study earlier this morning. The company said research has shown the vaccine candidate to be more than 90% effective in preventing the disease with trial volunteers who have not previously contracted a coronavirus infection. It means that protection against Covid-19 is achieved 28 days after the first vaccination, which consists out of two doses. No serious safety issues were identified during the investigation.
Half of the candidates received two doses of the candidate vaccine, while the other half received a placebo. The first analysis was based on 94 volunteers who developed Covid-19. With an effectiveness of more than 90%, most should be in the placebo group. That is why various experts are now extra positive about this development, because with such a high percentage it can be established that the development of the vaccine candidate can be very effective.
The Food and Drug Administration is next
Experts previously assumed a percentage around 50% to 60%, which is now well exceeded by the 90% that Pfizer published. Earlier, the Food and Drug Administration (FDA) said it will not approve a vaccine unless it is at least 50% effective. Now is the time to do more research on the vaccine candidate to get it to market as soon as possible. The company has made a promise that this will only be done in a way that our science allows.
Pfizer plans to submit a request to the FDA for an emergency authorization for the two-dose vaccine in late November. The company will have collected the necessary two-month security data around that time. An application for an emergency authorization (EUA) will also be submitted after the required safety milestone has been reached. By the end of 2020, its researchers are expected to have produced sufficient doses to immunize 15 to 20 million people.
Political pressure is not a factor for Pfizer
Earlier this year, Operation Warp Speed was established, a federal effort to get a Covid-19 vaccine to market as soon as possible. With this, Pfizer was promised $1.95 billion with the goal of producing 100 million doses to be distributed to Americans for free. But unlike the other big companies in the vaccine race, Pfizer didn’t take federal money to boost its research developments.
“Warp Speed was not in the company’s plans, and no money was ever taken from the US government or any other party.”
For Pfizer, the motto is that science determines how people work and not politics. The world is still waiting for the actual data and the long-term results are not yet needed, something that has already been discussed in political debates. For example, Donald Trump made various statements about a deadline for the marketing of a vaccine, which until now could not be fulfilled time and time again. The company stressed that it does not want to endanger public health in any form, especially if forced by political or financial disputes.
Based on current forecasts, Pfizer and BioNTech expect to produce up to 50 million doses of vaccine by 2020, which will increase significantly to 1.3 billion doses in 2021.
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