Within 11 months of the reporting of the virus to the world, the FDA has approved the Pfizer Covid-19 Vaccine.
On Friday, the Food and Drug Administration (FDA) said it authorized the first emergency vaccine of Pfizer Covid-19 in the United States, which is the first major, tedious indication for the Americans that the pandemic days are calculated.
- The Covid-19 vaccine of Pfizer has shown to be highly efficient and safe.
- The U.S. is the fourth country to release the Pfizer vaccine, after the UK, Canada and Bahrain.
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A letter from the FDA to Pfizer states that “the known and potential benefits of the Pfizer and BioNTech COVID‑19 vaccine” outweigh its potential risks to those 16 years of age and older.
“It is no less a medical miracle that the FDA has approved the Pfizer vaccine for Covid-19 within 11 months of the virus being reported to the world,” Health and Human Services Secretary Alex Azhar said in a statement Friday night.
In a statement, the FDA Commissioner Dr Stephen Hahn called the authorization “this is a significant milestone in the fight against this devastating epidemic that has affected many families in the United States and around the world.”
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The vaccine, produced by Pfizer and its partner BioNTech, is expected to be shipped nationwide soon this weekend and is targeted at leading health care workers and staff working in long-term care facilities.
Those two groups in the first phase of the vaccine roll represent about 24 million people – 3 million long-term care residents and 21 million health workers who are in the front line to treat Covid-19 patients.
With FDA approval, vaccine exports are expected to move rapidly so that the first vaccine dose can be managed on Monday or Tuesday. An official confirmed the news to NBC on Friday.
The covid-19 vaccine from Pfizer has demonstrated its safety and efficacy.
Phase 3 clinical trials of the vaccine reveal that when given in two doses at three-year intervals, it is 95 per cent effective in different age groups and races.
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There were a few opponents on the advisory board, however, some of them said there was not enough data to recommend scenes for teens 16 and 17, although there were participants at that age in clinical trials.
Dr Archana Chatterjee, dean of the Chicago Medical School and vice president of medical affairs at Rosalind Franklin University in Chicago, was one of the consultants for emergency use.
“We have limited safety and efficacy data on how the vaccine affects infant populations,” Chatterjee wrote in an email to CNBC.
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“Since most of them are ineligible to be vaccinated in the future, I hope we have time to gather and study additional data between this and the younger generation because they are not in the high-risk group.”
Otherwise, Chatterjee said Pfizer would support emergency use authorization for the vaccine.
Another member who voted no, Dr David Kim, director of the immunization division at the Office of Infectious Diseases and HIV / AIDS Policy of the Department of Health and Human Services, said in an email to CNBC that he would have voted yes “If voting is limited in recommending recognition to those 18 years of age and older.
In conclusion, the FDA determined that the data support the use of the vaccine in millions of people aged 16 and over, including healthy individuals.
So far, there is no indication that those with Covid-19 should not be vaccinated.
Covid-19 remodelling is considered rare, but if natural antibody levels decline over time, a person may become infected more than once.
The U.S. is the fourth country to release the Pfizer vaccine, after the United Kingdom, Canada and Bahrain.
Earlier this week, two health workers in the UK experienced severe allergic reactions immediately after receiving the Pfizer vaccine, prompting British regulators to warn people with a history of severe allergic reactions not to receive the vaccine.
Under the FDA guidelines, the company stated that people with a history of “severe allergic reaction” or anaphylaxis should not be vaccinated.