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WASHINGTON: Pfizer is “very close” to applying for emergency use approval for its COVID-19 vaccine after collecting safety data to send to US regulators, the company’s chief executive said on Tuesday (November 17), according to a report.
The pharmaceutical giant announced last week the preliminary results of a late-stage clinical trial showing that the injections it had developed in conjunction with Germany’s BioNTech were more than 90 percent effective after the second dose.
“We are very close to applying for an emergency use authorization,” Albert Bourla told the Stat medical news site. “We will announce it as soon as we are doing it.”
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Pfizer has previously said that it expects to contact the US Food and Drug Administration to request an Emergency Use Authorization before the third week of November, which means the announcement could take a few days.
The FDA had imposed a requirement on COVID-19 vaccine manufacturers to have at least two months of follow-up with volunteers after their second dose, taken 28 days after the first, to ensure the drugs are safe.
On Monday, Moderna and the US National Institutes of Health announced similar preliminary results from their own trial, and found that their vaccine was nearly 95 percent effective.
They both use mRNA (messenger ribonucleic acid) technology to deliver genetic material to the body that causes human cells to create a protein from the virus.
This trains the immune system to be ready to attack if it encounters SARS-CoV-2.
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Other vaccines that are in late-stage trials, such as one being developed by Johnson & Johnson and another by the University of Oxford and AstraZeneca, use modified viruses to deliver genetic material for the same purpose.
No mRNA vaccines have ever been approved, but Anthony Fauci, America’s leading infectious disease scientist, told AFP on Tuesday that the technology had been “established.”
Bourla told Stat that he was relieved that another vaccine was also successful and that he hoped many more would enter the fray because the global need was so dire.
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Moderna has previously said that it hopes to apply for an EUA before November 25.
After companies submit their application, the US could follow in a matter of weeks.
Moncef Slaoui, head of the US government’s Operation Warp Speed for the development of vaccines and treatments, said he awaits approval in the first half of December.
Given that companies that have been funded by the government have already been manufacturing their doses before approval, Slaoui says there will be enough between Pfizer and Moderna to immunize 20 million Americans in December.
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