Pfizer Vaccine Approved for Use in the United States

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Pfizer begins vaccination in the United States
Source: YAY Images
  • The United States is the latest country to approve the Pfizer coronavirus vaccine for emergency use.
  • The CDC gave its final recommendation on Sunday following FDA’s authorization on Friday.
  • Healthcare workers in New York are among the first group of people receiving the Pfizer vaccine.

Today, the United States began its COVID-19 vaccination drive following an official CDC recommendation. Pfizer and BioNTech submitted data from its joint vaccine’s phase 3 trials to the FDA in late November. The U.S. Food and Drug Administration (FDA) approved the vaccine for emergency use on Friday. Thus, the U.S has joined Canada, UK, Saudi Arabia, and Bahrain as the only countries to have approved the Pfizer vaccine for emergency use.

This official CDC recommendation follows Friday’s FDA decision to authorize the emergency use of Pfizer’s vaccine. As COVID-19 cases continue to surge throughout the U.S., CDC’s recommendation comes at a critical time.

CDC Director Dr. Robert Redfield

The FDA gave its approval after an evaluation of the vaccine’s safety, effectiveness, and manufacturing quality information. A panel comprising of 23 experts decided the known and potential benefits outweighed the potential risks of the vaccine. Therefore, approving the vaccine for emergency use in individuals aged 16 years and above.

United States Expecting 2.9 Million Doses of Pfizer Vaccine

Government authorities have ordered 2.9 million doses of the Pfizer vaccine for 636 sites across the U.S. The country aims to vaccinate 100 million people by March of next year.

We expect 145 sites across all the states to receive the vaccine on Monday, another 425 sites on Tuesday, and the final 66 sites on Wednesday, which will complete the initial delivery of the Pfizer orders for vaccine

Gustave Perna, chief operating officer of Operation Warp Speed
Healthcare workers are among the first people to receive the Pfizer vaccine in the United States.
Sandra Lindsay is one of the first group of people to receive the Pfizer vaccine in the United States
Source: AP

Although the FDA approved the vaccine for use in individuals over 16 years of age, the CDC recommends healthcare workers and nursing home residents receive it first. On Monday, Sandra Lindsay, an ICU nurse in New York City, became one of the first few individuals who received the newly authorized COVID-19 vaccine.

December’s Target: 1% of the Population

Further 2.9 million doses are expected to arrive for the second batch of vaccinations in the U.S. According to Pfizer and BioNTech, the US will likely receive a total of 6.4 million doses this month.

The vaccine is given in two doses, three weeks apart. Earlier results of the vaccine’s phase 3 trials reported a vaccine efficacy of 95%. Furthermore, the FDA did not find any major safety concerns for the Pfizer vaccine. Other than pain at the injection site, headaches, and fatigue, the participants did not report any major side effects.

Following an incident where two recipients of the Pfizer vaccine suffered allergic reactions, the U.K. warned people to avoid the vaccine if they have a history of serious allergic reactions. However, the FDA has only issued a warning for those allergic to the vaccine’s ingredients. Or, those who suffer an allergic reaction to the first dose.

Reference:

Commissioner, Office of the. FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine. 11 Dec. 2020, www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.

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