FDA Approves Pfizer Covid-19 Vaccine

A nurse prepares to administer the Pfizer-BioNTech COVID-19 vaccine at Guy’s Hospital in London, Tuesday, Dec. 8, 2020. (AP Photo/Frank Augstein, Pool)

(CN) — The U.S. Food and Drug Administration on Friday evening approved a Covid-19 vaccine developed by Pfizer and German partner company BioNTech, setting a plan in motion to begin distributing the shot as early as next week. 

The news comes one day after an independent panel of experts held an eight-hour hearing on the vaccine’s safety and voted to endorse its use to help end a pandemic that has now killed nearly 300,000 Americans. 

The decision could not have come at a more dire time. The United States recorded an all-time, one-day record of more than 3,100 virus-related deaths Thursday, breaking the previous single-day record set on Wednesday. 

With the FDA’s approval secured, states may begin the vaccine roll-out as soon as Monday or Tuesday. Healthcare workers and nursing home residents and staff will be at the front of the line to get the first of the two-dose vaccine. 

Individual states will make their own determinations on who else gets the first shots and where they will be administered. 

Federal officials have said 2.9 million doses could be distributed nationwide within days.

Data released by the FDA on Pfizer’s clinical trials shows that the vaccine is 95% effective at preventing Covid-19 across age groups, genders, and racial lines at least seven days after the second dose.

The trial data showed that the two-dose vaccine “met the prescribed success criteria” in a study with 38,000 participants aged 16 years and older.  

Although the vaccine requires two doses for full protection, the first dose alone has been shown to prevent severe bouts of the respiratory illness about 89% of the time. 

The United States is the fifth country to begin distribution of the Pfizer-BioNTech shot, after the United Kingdom, Canada, Bahrain and Saudi Arabia.  

Experts noted during Thursday’s committee meeting that more research is needed to determine the safety and efficacy of the vaccine for pregnant women, people who are immunocompromised and children under the age of 16. Pfizer plans to continue clinical trials even after distribution of the vaccine begins. 

The most common side-effects observed during the trials were skin reactions at the injection site, fatigue, headaches, muscle and joint pain, chills and fever.  

Although few serious side effects were observed in the participants, twelve experienced appendicitis and four developed cases of Bell’s palsy, a temporary form of facial paralysis. According to documents released by the FDA, those numbers are in line with the frequency seen in the general population. 

Two people who received the vaccine in the U.K. this week suffered allergic reactions, prompting British health officials to warn that individuals with a history of anaphylaxis should not get the shot. 

The White House announced Friday that the government will purchase 100 million more doses of another Covid-19 vaccine developed by Moderna which will be delivered between April and June. The government previously signed deals with both Moderna and Pfizer to deliver 200 million doses of their vaccines by March. 

The purchase means 150 million Americans can receive the two-step vaccination, leaving almost 180 million Americans still to be inoculated. 

An FDA advisory committee is scheduled to review the Moderna vaccine Thursday. 

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