The FDA Has Authorized The Emergency Pfizer-BioNTech Covid-19 Vaccine In The US
The United States FDA on Friday (11th December 2020) evening granted the EUA (emergency use authorization) to the Pfizer-BioNTech COVID-19 vaccine, making it the first-ever approved COVID-19 vaccine in the United States to make its way outside the clinical trials.
The first 6.4 million doses of this vaccine can ship within a few days.
The announcement came after a Food and Drug Administration advisory committee – the Vaccine and Related Biological product Advisory Committee, voted 17 to 4 for recommending and emergency use authorization to the Pfizer-BioNTech COVID-19 vaccine. The committee voted on if this vaccine’s benefits outweigh the risk in people age 16 and above.
The highly anticipated authorization for this potentially life-changing vaccine means that the healthcare workers facing the highest exposure to the disease and residents of long-term care facilities can now begin to receive the first of the two doses of this vaccine.
The most remarkable thing about the Pfizer-BioNTech COVID-19 vaccine is that the scientists working on creating this drug have come up with a working solution to fight a disease only discovered late last year. This unmatched scientific feat is also impressive because the vaccine creation used a new technology that yielded 95% efficacy in preventing COVID-19.
FDA Commissioner Stephen Hahn said in a statement that the tireless work scientists have put in towards the development of a new vaccine to prevent this novel, severe, and life-threatening disease is remarkable. The researchers achieved this feat in an expedited time-frame after the virus’s emergence – it is a true testament to scientific innovation and collaboration worldwide.
About 20 million people could get the vaccine in the next weeks, which is an essential step towards turning the tide of the ongoing pandemic that has taken the lives of more than 300,000 people in the United States. However, experts reckon that it will take a while before everyone in the country gets vaccinated, so in the meantime, people should keep on following the pandemic guidelines. That means wearing masks, practicing social distancing, and hygiene is still vital to slow down the spread of COVID-19.
How Does The Vaccine Work?
Pfizer-BioNTech COVID-19 vaccine called BNT162B2 is an mRNA vaccine that people can get in two shots administered 21 days apart. The first dose help prime the body, and the second one, given a few weeks later, will boost the vaccine’s response.
The mRNA present in the vaccine codes contains codes for a structure called the “spike glycoprotein” of the virus. It is the part that the SARS-CoV-2 uses to attach to cells. The vaccine triggers human boy to produce copies of that spike protein, eliciting an immune response that protects against coronavirus infection.
The mRNA method used in the vaccine is the newest approach to vaccine technology.
The team that developed and tested the Pfizer-BioNTech COVID-19 vaccine has published the New England Journal of Medicine’s safety and efficacy data.
The data consists of reports from more than 43000 participants; 21720 randomly received the vaccine, while 21728 participants randomly got a placebo. The data indicate that there were only eight COVID-19 cases among those who received the vaccine, compared to 162 instances of COVID-19 infection in the group that received placebo.
The published results also noted that a two-dose administration of the vaccine has an efficacy of 95% for people aged 16 or older.
FDA official Dr. Marion Gruber said in the FDA advisory committee meeting that fact sheet and prescribing information provided with the COVID-19 vaccine would warn people with severe allergic reaction history to any of its components should not take it.
The Pfizer-BioNTech vaccine will get distributed across the country. The state and local officials will oversee the distribution process and logistics in their states.
Healthcare workers and long-term care facilities residents are the first in line to receive the vaccine.
During the vaccine’s initial rollout, states will not get a fixed amount of the doses; some states will receive less than they previously anticipated.
In almost every case, the vaccine’s first shipment will arrive from Pfizer’s Kalamazoo, Michigan facility to hospital systems and pharmacies.
As instructed by the federal government, the production facility’s distribution method to individual hospitals and pharmacies in each state is different for every state. State health department officials coordinate with the federal officials in an effort codenamed “Operation Warp Speed.” However, there is a lack of a specific roadmap that explains how this process will succeed in working simultaneously in all 50 states.
With the first phase of vaccination in effect, we can expect to see more and more people getting the first shot of the Pfizer-BioNTech vaccine. In the meantime, the FDA will test and approve other vaccine candidates who will potentially speed up the vaccination process.