In a statement, the Food and Drug Administration (FDA) said it reviewed data from around 44,000 people before granting approval for Pfizer’s vaccine, which will now be marketed as Comirnaty. It was found to be 91% effective in preventing COVID-19 disease. You may be wondering what this means for you and your family. Here’s what you need to know.
Is the COVID-19 Vaccine Safe?
All three vaccines authorized or approved by the FDA have undergone—and continue to undergo—rigorous testing. They have all been found to be safe and effective in preventing severe COVID-19. According to the FDA, full approval of the Pfizer vaccine means that it meets the agency’s high standards for safety, effectiveness, and manufacturing quality. In order to receive full approval, the FDA required six months of follow-up safety data as well as inspections of the vaccine production centers to ensure product quality and safety. A Gallup survey released in early August 2021 found that about one in five Americans remains “vaccine-resistant,” and many of them have concerns about its safety. Many experts hope full FDA approval will give hesitant parents the reassurance they need to vaccinate their kids and themselves. “Protecting your children with the now FDA-approved COVID-19 vaccine is a decision that just got easier for parents,” says Carol Winner, MPH, a public health expert and founder of social distancing brand Give Space. “The approval of the Pfizer vaccine can provide parents the science-based reassurance they need to feel comfortable vaccinating their age-appropriate children.” Remember, children younger than 12 years old cannot currently receive any COVID-19 vaccine, but Pfizer and Moderna are currently testing in kids ages 6 months and older. Johnson & Johnson has announced its own pediatric clinical trial plans. Pfizer still has emergency use authorization for kids ages 12 to 15. This means the FDA and Centers for Disease Control and Prevention (CDC) have reviewed data from clinical trials and determined that the vaccine is safe and effective for this age group. “I would expect FDA approval will eventually be extended to the 12 to 15 age group,” says Charles Bailey, MD, medical director for infection prevention at Providence St. Joseph Hospital and Providence Mission Hospital in Orange County, California.
Will There Be a COVID-19 Vaccine Mandate?
The federal, state, and local governments have different regulations and policies. The federal government can mandate vaccines, but only to prevent transmission of a dangerous infectious disease across state lines or international borders. On the other hand, states and cities can require vaccines if it is considered necessary for public health. In November 2020, the New York State Bar Association passed a resolution urging lawmakers to consider implementing a vaccine mandate for residents. “FDA approval will increase vaccination through vaccine mandates for continued employment by various government (e.g. the military and government agencies) and private (healthcare and non-healthcare) entities,” Dr. Bailey says. In August, California became the first state to mandate vaccinations for teachers in public and private schools, kindergarten through 12th grade. If teachers do not get vaccinated, they will have to get tested at least once per week. Cities like Washington D.C. have also announced a vaccine mandate for teachers and staff, requiring that they be fully vaccinated or submit to weekly testing instead. New York City is the first city to have a no-option mandate, meaning teachers cannot use the weekly testing option as an alternative to getting vaccinated. And it could happen for kids, too. “Vaccine mandates are not new!” says Florencia Segura, a pediatrician at Einstein Pediatrics in Vienna, Virginia. “There is already some form of vaccine mandate in all 50 states for K-12 students. Think of your child’s yearly school health form and how the most critical part of that document is the updated vaccine record.” Other vaccines typically mandated by schools include varicella (chickenpox), polio, DTap (diphtheria, tetanus, and pertussis), and MMR (measles, mumps, and rubella). If vaccine mandates become part of the school system, people who are vaccine-hesitant or vaccine refusers will have limited options, Dr. Segura warns. “They will either have to be subjected to frequent testing or will need to remain virtual.”
Will Family Activities Be Affected?
It is fair to wonder if your family’s favorite indoor play area, store, or restaurant will require proof of COVID-19 vaccination. Regardless of any government mandates, businesses are permitted to set their own policies. For example, an employer can require their employees to show proof of vaccination before they are allowed to work in person at offices, even if the state hosting those offices doesn’t have a mandate. Businesses can also require vaccination among customers. New York City is currently requiring proof of COVID-19 vaccination at indoor dining establishments, some indoor entertainment venues like stadiums, bowling alleys, aquariums, and indoor fitness centers. Winner sees only the benefits of the latest development. “The FDA approval of the Pfizer vaccine will dramatically improve the lifestyle of the average American family by protecting their health and safety and that of others,” she says. “Community-wide protection comes with each vaccine, working toward a return to and enhancement of life’s privileges, such as healthcare, education, and social engagement.”
An approved vaccine for adults means that vaccine mandates may be enforced by local governments. Also, businesses can choose to require proof of COVID-19 vaccination from their customers. This may mean your favorite store, restaurant, or entertainment venue may be off limits unless you are fully vaccinated. Check your city’s and state’s guidance to learn more.
