Anju Goel, MD, is board-certified in internal medicine. She has over 10 years of experience in the California public health system addressing communicable disease, health policy, and disaster preparedness.
A vaccine is a major component of preventing COVID-19. In an unprecedented effort to curb the pandemic, scientists from around the world have come together to condense a 10-year research and development timeline into roughly 10 months. There are over 200 vaccines in development, and dozens are in clinical trials. In the United States, two vaccines have received emergency use authorization from the Food and Drug Administration (FDA).
To move at such a rapid pace, researchers explored new vaccine platforms, like mRNA. Manufacturers produced batches of vaccines without waiting for final clinical trial results in order to have them immediately ready if proven safe and effective. In spite of the speed, safeguards like data and safety monitoring boards remained in place throughout the process. A vaccine is only FDA-authorized once it is proven to be safe.
In the U.S., there are currently two vaccines with Food and Drug Administration (FDA) emergency use authorization: the Pfizer-BioNtech vaccine and Moderna vaccine. There are large-scale Phase 3 clinical trials in progress or being planned for three additional COVID-19 vaccines in the U.S.: AstraZeneca’s vaccine, Janssen’s (Johnson & Johnson's) vaccine, and Novavax’s vaccine.
The available COVID-19 vaccines underwent extensive safety and regulatory processes. In order for the vaccines to receive FDA emergency use authorization, each clinical trial was subjected to review from a panel of scientists who are independent of Pfizer and Moderna. These scientists are members of data and safety monitoring boards (DSMB) that review clinical trials of drugs and vaccines. DSMBs have vetted drugs and vaccines for decades.
The COVID-19 vaccine will be distributed in phases. The first phase prioritizes healthcare workers, residents of assisted living facilities, essential workers, older adults, and adults with certain medical conditions. Phase 1 distribution has already begun, and experts believe it may run until April, May, or June 2021. Phase 2 will prioritize schools, correctional facilities, homeless shelters, and more. Phase 3 will include children and young adults.
While more research still needs to be done, experts believe that the COVID-19 vaccines will be able to offer protection against new strains of the virus. Scientists say the virus would have to mutate extensively to escape this response. They believe the vaccines will still be protective against new strains that are not significantly different from the original virus.
Public health officials say to expect largely mild side effects. You may feel pain and redness at the injection site, fatigue, a headache, joint and muscle aches, and/or a fever. New reports suggest if you have a history of severe vaccine reactions, you may experience a similar reaction if you get the Pfizer COVID-19 vaccine. A very rare symptom may include a temporary weakness or paralysis of the facial muscles called Bell’s Palsy.
Experts believe it’s unlikely the government will institute a COVID-19 vaccine mandate to protect public health. Instead, the government will likely release recommendations and national standards for the vaccine. Vaccination requirements may be implemented through employers and schools—both of which have instituted vaccine requirements in the past.
Vaccines take an average of 10.71 years to develop from the preclinical research phase to final regulatory approvals. In order to compress this timeline to under a year, researchers had to overlap development phases, rely on existing vaccine platforms, and produce vaccines “at-risk” ahead of safety data, even if that meant throwing them away later.
Centers for Disease Control and Prevention. Different COVID-19 Vaccines. Updated December 28, 2020.
Pronker ES, Weenen TC, Commandeur H, Claassen EH, Osterhaus AD. Risk in vaccine research and development quantified. PLoS ONE. 2013;8(3):e57755. doi:10.1371/journal.pone.0057755