Big news from the US – The US Food and Drug Administration has given approval to BioNTech and Pfizer vaccine for emergency use, the first COVID-19 vaccine to get FDA approval for use in the US.
This was confirmed by FDA commissioner, Dr Stephan Hahn on Friday night. He said that this FDA approval for emergency use of the first COVID19 vaccine is a significant milestone in combating the pandemic that has affected millions in the United States and around the world.
As of today, covid cases rise up to 170 Million and deaths are above 3.52 Million globally.
Earlier on Friday, the White House was demanding vaccine approval or resignation from the FDA commissioner. This news was circulating all over electronic and social media. The news comes a day after the FDA advisory voted 17 to 4 to recommend the vaccine; with one abstention.
So now Pfizer COVID vaccine got FDA approval in the US after getting approval for broader public use in the UK, Canada and Mexico.
Donald Trump was repeatedly seen to push for early vaccine development. On Friday he told to FDA in a tweet “Get the dam Vaccines out NOW.”
Pfizer Vaccine BNT162B2 got FDA Approval
The FDA authorized the vaccine, known as BNT162b2. Innovative messenger RNA technology is used to make this vaccine that introduces the human body to the spike protein on the surface of the coronavirus. Trial results were published in the New England Journal of Medicine on Thursday.
It happened after a trial that involves more than 43,000 volunteers and they found it to be effective at preventing the covid-19 95% of the time. The majority of the participants were US nationals. Of these participants, 18,801 received the vaccine while 18,785 received the saline placebo. They were followed for the duration of average of 2 months after the administration of the second dose. The most commonly reported side effects were headache, tiredness, pain at the injection site, chills and fever.
The US states will receive 2.9m doses soon from Pfizer. US Center for Disease Control and Prevention (CDC) will prioritize healthcare workers and long term care residents for the administration of the vaccine. To achieve 95% efficacy, these people will receive a second booster dose after the states another 2.9m doses next week.
Now about the distribution and administration of the Pfizer COVID vaccine to the general public, experts say it may take mid to late 2021. That means pandemic risk is not over. Individuals will still have to wear masks, observe physical distancing, hand wash and avoid crowds.
The United States need to vaccinate 80% of all adults to achieve so-called herd immunity. Scientists believe this is an exceptionally high level of vaccination that has never been achieved so far.
The federal health authorities aimed to vaccinate 20 million people before the year is out. If achieved, that number would still fall short of vaccinating 21 million healthcare workers and 3 million long-term care residents of all of the nation’s states.
Another FDA approval for the COVID-19 Vaccine is coming?
Next week, FDA advisory panel will be hearing evidence on a second COVID-19 vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases and called mRNA-1273.
Scientists are still finding the answer to most asked question after vaccine development i.e., How long the COVID-19 vaccine would provide immunity? At this time there is no evidence about immunity duration and the prevention of transmission of SARS-Cov-2 person to person.
The EUA (Emergency Use Authorization) was issued to Pfizer Inc. for BioNTech and Pfizer vaccine. This vaccine is authorized for 16 aged people and older. The company is studying for children age 12-15.
The company has submitted a pharmacovigilance plan to FDA to monitor the safety of the BioNTech – Pfizer vaccine for COVID-19. The safety of participants on-going trial is very important, so this plan follow-up for participants enrolled. It includes other activities aimed to enhance the safety profile of the BioNTech – Pfizer vaccine and also ensures that any safety concerns are identified will be quickly executed.