Yesterday was a monumental day in the once-in-a-century pandemic that has killed nearly 300,000 American in less than one year. The Food and Drug Administration late last evening granted emergency authorization to Pfizer/BioNTech’s covid vaccine for people 16 and over. The FDA found clinical trial data (with 44,000 participants) from Pfizer’s vaccine to be not only highly effective but also safe. The FDA authorizes treatments including vaccines based on safety and efficacy data. The vaccine requires two doses and is 94.8% effective after seven days of the second dose. United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine.
The vaccine from Pfizer and BioNTech must be kept at an ultracold, minus-94 degrees Fahrenheit. The company has created its own GPS-tracked coolers filled with dry ice to distribute it. Each vial of the Pfizer vaccine has five doses when diluted. Once thawed, the undiluted vial can be kept in a refrigerator for only five days. A diluted vial can be kept for only six hours.
The Pfizer vaccine is the first vaccine using messenger RNA technology ever approved for human use by the Food and Drug Administration. It is different from more traditional vaccines, which often use a weakened or dead version of a virus, or a laboratory-generated protein. Pfizer’s vaccine uses a snippet of the virus’s genetic code to instruct cells to build the spike protein on the surface of the coronavirus, teaching the immune system to recognize the spike protein and destroy the virus in infected individuals.
The side-effects profile of the Pfizer vaccine includes pain at the injection site, as well as fatigue, chills and fever. FDA said there were four cases of Bell’s palsy (temporary weakness or paralysis of muscles of the face on one side) in the vaccine group and none in the placebo group. Intensive safety monitoring will continue after the vaccines begin to be used.
Health-care workers and first responders are likely to be among those prioritized for vaccination. People who have essential jobs, such as teachers and food workers; those who are at higher risk because of their age; and those who have underlying conditions that increase their risk for severe disease are also likely to receive earlier access. Healthy younger adults who don’t have medical conditions or high-risk jobs are likely to begin to get vaccinated starting March-April. The great challenge will be persuading the majority of people in the U.S. to get vaccinated. In order to get a herd immunity in the country, roughly 70% or more of the population will need to be vaccinated against the virus.
Even after a vaccine is approved, people will need to wear masks and socially distance — in part because the vaccine doses will be limited, and it will take time to immunize enough of the population to stop the virus from spreading. It is extremely important that we bring this pandemic under control as quickly as possible by taking the vaccine. This will save thousands of lives and bring back normalcy in our lives once again.