Pfizer is requesting FDA emergency use for its COVID-19 vaccine in the US
Last week, we wrote about Pfizer after the pharmaceutical giant announced that its COVID-19 vaccine offers 90% protection. Today, Pfizer and partner BioNTech announced that they are submitting a request to the U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate.
According to the announcement, 80% of all 2020-2021 doses already sold to rich countries and 50 million doses of the vaccines are expected in 2020, half to the U.S. In a statement, Pfizer said it is submitting a request to the US Food and Drug Administration for emergency use authorization of the vaccine it developed with BioNTech. The news comes days after the pharmaceutical company released positive initial findings from their phase three trials.
Pfizer said that the vaccine has been tested on 43,500 people in six countries, with no safety concerns raised. This is a major victory in the fight against a pandemic that has killed more than a million people.
In a joint announcement, Pfizer and its partner BioNTech conducted human trials on 43,500 people in six countries, with no safety concerns raised. The two companies plan to apply for an emergency approval from the FDA by the end of the month to use the vaccine.
Back in July, we wrote about Pfizer after the drug giant, and the biotech firm BioNTech reportedly improves immune responses in healthy patients. According to the study documented in a 16-page paper, researchers randomly assigned 45 patients to get one of three doses of the vaccine or placebo. Twelve receive a 10 microgram dose, 12 a 30 μg dose, 12 a 100 μg dose, and nine a placebo. The 100 μg dose caused fevers in half of the patients; a second dose was not given at that level.