New FDA Guidelines Likely to Delay Coronavirus Vaccine Approval

Recently, the U.S. Food and Drug Administration has issued new guidelines for the emergency authorization for the potential coronavirus vaccine approval and its launch into the market for usage and distribution purposes. On Tuesday, the agency finalized the instructions, which are much stricter in comparison with the previous ones. This means that a coronavirus vaccine is unlikely to get approval anytime soon.

A few weeks ago, the president of the US, Donald Trump had stated that a coronavirus vaccine will likely be available before the presidential elections in early November. Although clinical trials on the tested formulas reported positive results, the comment by the president received a lot of criticism from the medical community.

A number of health experts, including those who are a part of the White House task force, did not agree with President Trump. In fact, the task force only stated that they will ensure the vaccine launched in the future will not only be effective but will be safe for usage without any adverse effects.

However, the politicization of the race of developing a coronavirus vaccine had convinced many people that vaccination will be available in the market before the month of November even if it has not passed mandatory scientific processes and is harmful.

Prior to the statement on vaccines, President Trump along with a number of prominent political leaders has also played a part in neglecting fundamental advice on controlling the coronavirus pandemic from the medical community.

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In addition, in many instances, the sudden change in decisions by the FDA or the U.S. Centre for Disease Control and Prevention has been linked with the Trump administration. Any guidelines that go not go with the narrative promoted by the current government have been changed repeatedly in the past six months.

Earlier in the pandemic, the emergency approval by the FDA had been used for approval of drugs including Remdesivir and hydroxychloroquine.

The approval of these drugs, especially hydroxychloroquine, which has been touted by the president was deemed to be a result of political pressure. Later on, the approval for the drug was also revoked due to reports from clinical trials that clearly show that hydroxychloroquine caused life-threatening side effects and offered no benefits for coronavirus patients.

The recent change in guidelines regarding coronavirus vaccine approval, though, is a positive change and shows a victory of science and medicine over politics and vaccine nationalism.

According to the new instructions, the time of observation of the effects of the formula being tested in participants has to be at least two months. Although two months is the minimum time to look out for any adverse effects associated with a potential vaccine, the time period is longer than before.

This will allow the vaccine to be safer than before and help in knowing at least the immediate side effects of the vaccine.

Currently, there are a total of three formulas that are in the final phase of their clinical trials but stricter guidelines for coronavirus vaccine approval means they may also be launched in the market after several weeks from now.