Pfizer will apply for emergency permission to distribute its covid-19 vaccine in the US and is ready to start shipping the shots within “hours” of getting a government green light, the firm said today. It is the first such application from any of the makers of covid-19 vaccines that are currently in development.
If it is approved, the first people to get the shot are likely to be doctors, nurses, and other front-line workers, and that could happen before Christmas, according to the drug giant. Pfizer is also sharing information with regulators in Canada, the European Union, and Japan.
In a statement, Pfizer’s CEO, Albert Bourla, said the vaccine's development took “248 long days and nights,” involving 43,661 volunteers at 150 locations in the US, Turkey, and South Africa. Pfizer claims its vaccine has proved to be 95% effective in its final trials.
Pfizer and its partner, German firm BioNtech, believe they can produce about 50 million doses by January, and as many as 1.3 billion doses by the end of 2021. Each recipient needs two doses, spaced weeks apart. “The companies will be ready to distribute the vaccine within hours after authorization,” Pfizer said.
While Pfizer’s vaccine may be the first to win authorization in the US, vaccine organizations say shots from several other companies will still be needed. That’s because no one company, or technology, can meet global demand for vaccination.
Other vaccines include one being developed by Moderna Pharmaceuticals, based in Massachusetts; another from AstraZeneca and Oxford University that’s in late-stage testing; and vaccines already authorized in China and in Russia.
The development of a vaccine for a new disease in less than a year has shattered all records, yet it won’t come soon enough to intercept the current winter wave of covid-19 cases in the US and Europe, where infections have reached an all-time high. The US alone is recording more than 170,000 coronavirus cases per day. If undetected infections are accounted for, that could mean half a million Americans are catching the coronavirus every 24 hours.
Because vaccines supplies will be limited at first, most people will have to wait until the middle of 2021, or beyond, to get vaccinated with the Pfizer shot or one from another company. That means for now, avoiding the virus still means avoiding other people. This week, the US Centers for Disease Control began discouraging Americans from traveling for the Thanksgiving holiday next Thursday.
Pfizer's request to market its vaccines now means it is up to the Food and Drug Administration whether to issue a type of fast-track approval called an “emergency-use authorization.” A committee of advisors will meet in December to assess Pfizer’s data documenting how well the shots worked.
Some experts still question whether a vaccine should be rushed out, saying a formal, somewhat longer approval process would create more confidence in the product among the general public.
Since March, the FDA has used it emergency authorization power to allow the sale of four medical treatments for covid-19 (hydroxychloroquine, donor blood plasma, the antiviral remdesivir, and an antibody), each time on the basis of limited evidence. In every case, it remains disputed whether any of those drugs actually prevent patients from dying.
The Pfizer vaccine employs a novel technology in which part of the virus’s genome is packaged inside fatty nanoparticles. A person’s own cells then use that information to manufacture a single viral protein, called a “spike,” which trains the immune system to recognize the pathogen.
Pfizer said that it is able to manufacture and distribute its vaccine from several locations in the US and Europe and will use special ultra-cold shipping boxes tracked by GPS devices, since its product needs to be kept at a temperature of -70 °C.
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