The vaccine safety system in the United States is working to ensure that all vaccines are as safe as possible. Safety has been a top precedence as federal agencies work with vaccine producer to develop and allow a COVID-19 vaccine. Here are a few key areas that are fraction of the growth, corroboration, and endorsement of a COVID-19 vaccine:
All vaccines are clinically tested to verify safety and efficacy. For the COVID-19 vaccine, the Food and Drug Administration (FDA) has set strict standards that vaccine developers must meet. This infographic from the National Institutes of Health shows the four phases that a vaccine must go through before it is released.
Permission for emergency use
Vaccines that meet FDA safety and efficacy standards may be available in the United States with an Emergency Use Authorization (EUA) approval or authorization. The EUA provides temporary authorization for a vaccine or drug in emergencies such as the corona virus pandemic.
Continuous monitoring of problems and side effects
Once a vaccine is approved, monitoring continues and systems are in place to track problems or side effects that were not detected in clinical trials. In terms of the COVID-19 vaccine, the FDA and the Centers for Disease Control and Prevention (CDC) are expanding vaccine monitoring. If there are problems with the vaccine, they are likely to show up early in the testing process, when they can be identified and corrected.
Were there any concerns about the safety of the COVID-19 vaccine?
So far, none of the vaccine trials have reported any major safety issues. Trials of the first two vaccines – from Pfizer and Modern – were conducted by fully independent safety monitoring commissions, and safety data are continually reviewed by the FDA and expert panels.
The CDC reports that people with allergies to certain foods, insects, latex, and other common allergens can receive the COVID-19 vaccine. Those with a history of a severe allergic reaction (anaphylaxis) to injections or other vaccines should discuss vaccination with their doctor, who can assess the person and assess their risk. According to the CDC, at this time, anyone with a serious allergy (such as anaphylaxis) to any of the ingredients in the Pfizer / BioNTech vaccine should not receive this vaccine.
How was the COVID-19 vaccine developed so quickly?
In the past, it took many years to develop vaccines. However, the relatively rapid development of this vaccine does not mean that safety measures have been overlooked. There are several reasons why COVID-19 vaccines have been developed faster than other vaccines:
- The mRNA technology used to develop vaccines against COVID-19 has been developed over the years to prepare for outbreaks of infectious viruses. Thus, the production process was ready very early for the pandemic.
- China shared genetic information about the SARS-CoV-2 corona virus when it was available, giving vaccine developers an early start in their search for a vaccine.
- Vaccine testing processes did not skip any steps, but vaccine developers went through multiple steps of the process at the same time to collect as much data as possible.
- Governments gave money in advance to vaccine developers so that companies had the resources they needed.
- Several types of COVID-19 vaccines have been created using messenger RNA (mRNA), a new technology that allows for a faster approach than the traditional method of producing vaccines.
- Social media allowed companies to connect with volunteers for research and recruit them, and many people wanted to help, so there were enough study participants to test the COVID-19 vaccines.
- Because the SARS-CoV-2 corona virus is so contagious and widespread, many of the volunteers who received the vaccine were exposed to the virus, and with so many exposures, testing took a shorter time to make sure the vaccine worked.
- Companies have started producing vaccines prior to approval or approval, so some supplies will be ready if permission is obtained.
How effective are COVID-19 vaccines?
The Pfizer vaccine was approved on December 12, 2020, and the Moderna version is under FDA review. Both manufacturers report that their vaccines are approximately 95% effective in preventing both mild and severe symptoms of COVID-19. This level of effectiveness appears to be applicable to age groups, racial and ethnic groups, and both genders, as reported in the Pfizer study.
Will I still have to wear a mask and take COVID-19 precautions if I get the vaccine?
Yes, everyone still needs to follow these precautions for the foreseeable future. If you are among the roughly 5-10% of people for whom the vaccine is ineffective, you can still get infected and spread the corona virus. Research is examining whether a vaccine, even if it is effective in preventing disease, keeps a person from getting the virus and passing it on to others.
What are the side effects of the COVID-19 vaccine?
Vaccine developers report side effects that include pain at the injection site, fever, muscle aches, fatigue, and headaches that usually last for about one or two days. If symptoms persist, see your doctor. If you have an allergy, especially a severe one, that requires an EpiPen, discuss the COVID-19 vaccine with your doctor, who can assess your risk and provide more information on whether and how to get vaccinated safely.