On Friday Emergency Use Approval (EUA) by the United States Food and Drug Administration (FDA) was granted that allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the U.S. The FDA commissioner, Dr Stephen Hahn, confirmed the news on Friday night. ‘The FDA’s authorization for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around he world.’ he said.
The FDA is an agency within the United States Department of Heath and Human Services which protects the health of the public by assuring the safety, effective and security of human and veterinary drugs, vaccines and other biological products for human use. The FDA have stated that EUA is not the same as full approval for the vaccine, which to achieve would require that Pfizer file a separate application in order to secure it.
Dr Peter Marks head of the FDA’s Centre for Biological Evaluation and Research has said that the few reactions that have recently occurred in the United Kingdom (UK).. ‘were not seen in the larger trial data sets, but we still need to know more and we’ll be taking precautions.’ Marks also said that he was ‘comfortable giving the vaccine to patients who have had other allergic reactions other than severe allergic reactions to a vaccine or its components.’ He did advise that those previously affected with allergies should consult a doctor.
The U.S. has been particularly hard hit during the Pandemic with over 305,000 deaths. The vaccine is set to be distributed out of Pfizer’s main facilities in Michigan with the intention of being administered as soon as possible to the first highest-priority recipients.
The U.S. approval of the Pfizer/BioNTech vaccine follows the lead of other countries which include Canada, Mexico and the U.K.
The Pfizer/BioNTech vaccine is a new type of inoculation called an mRNA that utilizes a tiny fragment of the genetic code from the coronavirus to instruct the body how to fight the virus and build immunity to it. The FDA has said that; ‘When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against (Covid-19)
The vaccine is given as two injections approximately three weeks apart with the full effect said to be reached seven days after the second dose. Pfizer is planning on having 6.4 million doses ready for the U.S. speed warp vaccination program by late December.
In a video posted to Twitter on Friday night, President Donald Trump praised the vaccine as ‘one of the greatest scientific accomplishments in. history,’ also advising that the first dose of the vaccine would be administered in less than 24 hours. Although Trump also said that the vaccine ‘will vanquish the virus and return life back to normal.’ officials have warned that it could take till the spring of 2021 for enough people to be vaccinated before that scenario could occur and that in the meantime it is vitally important to practice good hygiene, wear masks and observe social distancing to help control the infection rate.
Researchers are still investigating how long the duration of immunity triggered by the vaccine will last and whether the vaccine can prevent transmission of Covid-19. The vaccine has been authorized for use in the U.S. for people aged 16 years or older. Studies on vaccination for children aged 12-15 are still continuing.
A Pew Research Center survey which was conducted in November found that 60% of American adult respondents were willing to get vaccinated if a “vaccine to prevent COVID-19 were available today” Eighteen percent said they would “definitely not” take the vaccine, with 21% saying they would “probably not” take it. Experts in the U.S. believe that for vaccination levels to achieve “herd immunity” that 80% of all adults would need to be vaccinated. That is an ambitious and extremely high level of vaccination results never before achieved in the U.S.
The FDA’s decision on Friday night could perhaps fuel the public perception that the development of the vaccine has been rushed This is combined with conspiracy theories and general distrust of vaccines from some people in general. To alleviate any concerns that people may have in having the vaccine, three ex U.S. presidents; Barack Obama, Bill Clinton and George W. Bush have offered to publicly get vaccinated to help persuade those against receiving the vaccine that it is safe. ‘I promise you that when it’s been made for people who are less at risk, I will be taking it. I may end up taking it on TV or having it filmed, just so that people know that I trust this science,’ Obama stated in an interview on Sirius XM’s the Joe Madison Show.
Amid some reports of White House pressure in receiving the go ahead for the EUA for the vaccine, President-elect Joe Biden stated that; ‘There is no political influence.’ and reiterated that the public should have confidence in the vaccine with a reported 95% success rate. This reassurance comes after the EUA was given the green light on Friday night after Trump tweeted that the FDA is a ‘big, old, slow turtle.. ‘ It was also reported by the Washington Post that White House chief of staff Mark Meadows told FDA Commissioner Dr. Stephen Hahn that he should submit his resignation if Hahn did not approve the vaccine on Friday. However Mr Hahn has refuted these allegations as “untrue.” He stated that he had only been ‘encouraged to continue working expeditiously’ on approval of the vaccine.
Biden has continuously called for American citizens to practice social distancing and wear facemarks in an effort to curb the out of control spread of the coronavirus. He has vowed to supply 100m vaccinations for the U.S. in his first 100 days of office and also urged Americans to “mask-up for 100 days” Biden is consistently seen donning a mask where as Trump who has already had coronavirus and recovered is rarely spotted wearing one.