Even though more than 60% of Americans have received at least one dose from the Covid vaccine, many Americans are still reluctant to get vaccinated. This is despite the fact that the highly contagious Delta variant continues to spread. Doctors and epidemiologists believe that full approval will convince some Americans that the vaccines are safe. A Kaiser Family Foundation survey found that 3 out 10 adults who are not vaccinated would prefer to have one of the vaccines fully approved.
Janet Woodcock, acting FDA Commissioner, stated that Pfizer's vaccine met FDA's "high standards of safety, effectiveness and manufacturing quality". We recognize that while millions have received COVID-19 vaccines safely, some may feel more confident about getting vaccinated now that the FDA has approved a vaccine.
According to the U.S. agency, FDA scientists reviewed "hundreds upon thousands of pages" vaccine data from 40,000 trial participants. The vaccine was 91% effective in preventing Covid, slightly less than the 95% efficacy rates trial data showed at the time the shot was approved late last year. This was before the Delta variant became available in the U.S.
Since the submission of the vaccine application by Pfizer and BioNTech to the FDA in May, federal health officials have been under increasing pressure from advocacy groups and the scientific community to approve the vaccine. On May 7, the FDA approved a Biologics License Applications by the companies. This allows patients 16 years and older to receive full approval.
The mRNA vaccine, now known as Comirnaty by its brand name, was available on the U.S. marketplace under an FDA Emergency Use Authorization granted in December. According to data from the Centers for Disease Control and Prevention, more than 200 million Pfizer shots were administered since then.
Monday's Food and Drug Administration approval granted Pfizer and BioNTech Covid-19 the full approval. This makes them the first vaccine companies in America to be awarded this coveted title. It also gives more schools and businesses confidence to accept vaccine mandates.
Full approval is "more psychologically than any other," Dr. Paul Offit, a voting member on the agency's Vaccines and Related Biological Products Advisory Committee said. "It means that you have already administered more than 320,000,000 doses. Vaccines have a high safety and efficacy profile.
U.S. approval will likely spur a new wave in vaccine mandates from corporations America. Some or all employees of major companies, from Walt Disney to Walmart, have been told by their managers that they must be fully vaccinated against Covid in the fall. Despite having the legal authority, some private companies may not have been able to require the shots without prior approval. Dorit Reiss, a professor at UC Hastings College of the Law, stated that this is despite the fact that they were legally authorized.
According to the Pentagon, vaccinations will be mandatory for military personnel "no later than September middle" or sooner if FDA gives full approval.
When asked by Dr. Anthony Fauci, chief medical officer of the White House, about the full approval of vaccines, Dr. Fauci stated Aug 8 that "You're going see the empowerment of local enterprise, giving mandates that could include colleges, universities or places of business a whole variety, and I strongly support that." "It's now. "We have to do more to get people vaccinated."
Pfizer's shot of Covid is the first to be approved by the U.S. regulatory authorities. Federal regulators previously stated that they would speed up the process to remove Pfizer vaccines.
Standard vaccine reviews take several months to a full year to determine if they are safe and effective enough to be used in the public. The pandemic that has claimed the lives of more than 620,000 Americans led to FDA authorizing the use of shots under the EUA.
Emergency authorizations allow for the expedited approval and manufacturing of vaccines in a state of public health emergency. Alex Azar, former Health Secretary, declared a public emergency on January 31, 2020. This health emergency was renewed multiple times, the most recent in July. FDA approved the use of the shots after receiving only two months of safety data from an EUA. This is not the same as a Biologic Licence Application or a Request for Full Approval, which require at least six months' of data.
FDA scientists must carefully review the clinical trial data of each company before granting approval. This includes any safety concerns or discrepancies. Offit is also the director of the Vaccine Education Center at Children's Hospital Philadelphia.
Offit stated that it's a lot data. Offit previously stated that Merck's data from its 70,000-person Rotavirus vaccine trial was so large that the pages generated could have surpassed the height of the Sears Tower, a Chicago skyscraper measuring 1,450 feet.
He stated that "the FDA will do whatever it needs to ensure that the American people are safe."
Companies that submit an application for full approval are also greatly benefited, Dr. Robert Califf, ex-FDA Commissioner, said in a May phone interview.
Pfizer and BioNTech can now market the shots directly to American consumers with this agreement. He said that companies cannot promote their products within an EUA. The EUA allows for the shot to remain on the market after the pandemic has ended and the U.S. no longer considers itself an "emergency".
Califf stated that the vaccines would still need to be administered by a qualified professional. They cannot send vaccines directly to the homes of people. They can however advertise on TV and promote the products, but they must be under the strict supervision of the FDA.
Pfizer and BioNTech both stated that they expect the vaccine to bring in billions of dollars. Health experts warn that the companies may also decide to charge more for vaccines if they receive full approval.
According to the Financial Times, the companies have raised the price for their vaccine in Europe. According to the report, they now charge $23 per dose compared to their $18.40 price previously.
BioNTech and Pfizer also plan to request the FDA approval for a third dose of booster shots after full approval. The Biden administration announced last week that it would begin offering booster shots to all eligible Americans starting Sept. 20.
This is still a developing story. Keep checking back for more updates.
