To date, the data suggests the vaccines are very safe.
The FDA has evaluated the data from clinical trials prior to approving each vaccine. In the clinical trials, more than 30,000-40,000 persons received the vaccine. In order to receive Emergency Use Authorization by the FDA, the company who manufactured the vaccine must have followed at least half of study participants for two months or longer, after receiving both doses of vaccine, and the vaccine must be proven safe and effective.
In addition to the safety review by the FDA, the Advisory Council on Immunization Practices (ACIP) also convened a panel of vaccine safety experts who independently evaluated all safety data. This means two panels of experts have carefully reviewed the data for each vaccine.
In addition, the Centers for Disease Control and Prevention (CDC) continue to carefully monitor the vaccine safety and will regularly share clear and accurate information with healthcare providers and the public.
Is The J&J Vaccine Safe?
The FDA and CDC have confidence that the J&J vaccine is safe and effective in preventing COVID-19. The FDA has determined that the available data shows that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older. At this time, the available data suggests that the chance of blood clots with low platelets occurring is very low. However, according to the CDC, women younger than 50 years of age should be aware of this rare risk of blood clots with low platelets following vaccination, as well as the availability of other COVID-19 vaccines where this risk has not been observed.
The COVID Vaccine Was Developed Very Quickly. Did They Cut Any Corners On Safety?
The COVID vaccines are going through the same rigorous safety assessments as have other vaccines, and corners are not being cut. The COVID vaccine uses a new technology where messenger RNA is injected, as opposed to a piece of the virus. Messenger RNA contains the instructions for your body to make a protein related to the virus, but not the actual virus. Your immune system will then make antibodies to that protein. If you are then exposed to COVID infection, your body will rapidly recognize the protein, and will be primed to fight off infection very early, preventing you from developing severe illness.
This vaccine has been developed more quickly than previous vaccines, leading some people to worry that this was rushed. Advances in genetics allowed scientists to determine the genetic code of the COVID-19 virus very early, which was critical to making the messenger RNA for the vaccine. These vaccines have been carefully studied, and large numbers of volunteers who received the vaccines have been closely followed for side effects. The data suggests these vaccines are very safe.
Does The J&J Vaccine Cause Seizures?
The CDC’s ACIP, an independent panel of medical experts who reviewed data following concerns with the J&J vaccine, confirmed that seizures may be seen in persons who develop blood clots to the brain, which are very rarely associated with the J&J vaccine. On April 23, 2021, ACIP voted to reinstate the original emergency use authorization of J&J’s vaccine given that the benefits outweigh the risks. There is currently no evidence that persons with epilepsy are at higher risk of side effects after vaccination.
When people have a blood clot that disrupts blood flow to the brain, this can lead to seizures; however, these seizures are not equivalent to epilepsy. As with any vaccine, some people may develop a fever that could lower their seizure threshold for the short term, but rarely could result in a break-through seizure. There is currently no evidence that the J&J vaccine (or any of the other vaccines currently available under EUA) results in worsening of the epilepsy, or brain injury.