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All Potential COVID-19 Vaccines Must Pass These FDA Requirements

A COVID-19 vaccine is big news right now. Politicians like President Donald Trump are pushing for a vaccine to be approved by November 3rd. This has caused worries about whether these vaccines will be tested thoroughly enough. Even an expedited vaccine or one given an emergency approval will still have to meet certain FDA requirements before they can be used.

What is Normally Required for a Vaccine to be Approved by the FDA?

Under normal circumstances, any potential vaccine or any drug requires multiple phases of testing to prove safety and then efficacy.At minimum, there are 3 phases that a vaccine goes through to be approved. In Phase 1, small groups receive the vaccine. After it passes that trial, it goes to Phase 2. The clinical study is expanded to include members of the group the vaccine is intended for. In Phase 3, thousands receive the vaccine to be certain the vaccine is both safe and effective.

Many vaccines will also have a continuing Phase 4 trial to be sure of long-term safety and efficacy. Even after approval, the Vaccine Adverse Event Reporting System exists to report side effects and ensure that vaccines are safe for patients. This process normally takes several years.

Will the COVID-19 Vaccine Go Through All of This?

The short answer is yes, but on an accelerated timeline. Currently, any vaccine for COVID-19 will need to prove to be 50% effective in order to be approved. Anyone who received the vaccine during the trial will need to be monitored for 2 months after their last dose to ensure there are no adverse reactions. The initial trial won’t include children or pregnant people, later trials will determine if the vaccine is effective for these groups. Other groups that weren’t included in the original trial will also need to be tested.

Besides following participants for 2 months, any approved vaccine will need to see at least 5 severe COVID-19 cases in the group that received the placebo.

To prove 50% efficacy, a person who received the vaccine during the trial needs to be proven to have a 50% lower risk of developing symptomatic COVID compared to those in the placebo group.

These guidelines are meant to ensure safety. While the process for developing a vaccine may be accelerated, the goal is for it not to be rushed through and cause more harm than good.

Can a COVID-19 Vaccine be Pushed Through Any Faster?

A vaccine could be approved through an Emergency Use Authorization (EUA). This would allow the vaccine to be used quickly in situations such as the pandemic our society is currently experiencing. However, even if an EUA is given, trials would still continue.

This happened earlier this year with hydroxychloroquine. However, this EUA was revoked when it was proven that there were few benefits according to further testing. This could happen if a COVID-19 vaccine were given an EUA. The FDA has stated that any vaccine given an EUA would be considered experimental until a Phase 3 trial was successfully completed.

Phase 3 trials are intense to go on as long as possible even with an EUA to ensure as many results are gathered as possible. This is because some adverse events may not be seen until large numbers of people from many groups are tested. The FDA has indicated that granting an EUA will not be a valid reason to suspend Phase 3 trials.

Drugmaker Pfizer indicated that if its vaccine receives an EUA, it intends to give the vaccine to patients who received the placebo during the trials. However, this move has been criticized by a deputy director of the FDA’s Division of Vaccines and Related Products since this removes a controlled follow-up study as a possibility.

Further Trials Required

The current trial does not include groups such as pregnant people and children. In order to ensure the vaccine is effective, further Phase 3 trials for these groups are required. Pfizer has announced that it will be enrolling children as young as 12 in a trial already.

While these trials are ongoing, it will be unknown if these vaccines are safe and effective in these populations. Other groups that have been noted as absent in initial trials will have their own trials done as well.

In addition to these, studies on how effective the vaccine is based on coverage in a population will occur. This means that researchers will look at how many people are vaccinated in a given area versus the rates of COVID-19 in these areas.

Other scientists will monitor the virus itself for changes that could make the vaccine less effective. Many viruses do mutate over time in ways that make vaccines less effective over time. This is also true of any medication developed to counteract COVID-19.

Monitoring for continued safety will be carried out by the FDA and CDC. This is standard for any vaccine given that some adverse reactions are incredibly rare or only found in certain specific groups like young children or people with certain underlying conditions.

Concerns Over the Vaccine Continue

Because of a number of factors like the speed of the development of the vaccine and distrust for the government have left many members of the public unsure if the vaccine will be as safe as those currently on the market.

Many marginalized groups surveyed have concerns over whether they are represented in the trials to ensure safety. They worry that if they aren’t considered, they could be given a vaccine that isn’t as safe or effective for them.

Distrust of the speed of the process is another big hurdle as well as distrust of the healthcare system. While neither of these types of concern are entirely easy to remedy, it has been proposed that transparency is important to gain public trust.

This would include measures such as holding online meetings. Allowing people to see for themselves how the process works can increase trust in the system.

The content on this page is for informational and educational purposes only and does not constitute professional medical advice. Patients should not use the information presented on this page for diagnosing a health-related issue or disease. Before taking any medication or supplements, patients should always consult a physician or qualified healthcare professional for medical advice or information about whether a drug is safe, appropriate or effective.