FDA Announces Standards to Approve COVID-19 Vaccines

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The Food and Drug Administration (FDA) will tighten the standards for emergency approval of a vaccine against COVID-19 to increase the confidence of the population, but making it difficult for the possibility of a vaccine being announced with the guarantees enough before November 3, the day of the general elections.

According to The Washington Post, the FDA may release the new regulations this week to increase transparency and build public confidence in the approval and distribution process of a COVID-19 vaccine, which President Donald Trump has promised that It will be available to the population before the end of the year.

Some analysts and health security experts feared that regulators were giving in to pressure from the White House to announce the success of a vaccine before the November election, so that the news propped up Trump’s chances of an electoral victory.

The new regulation, which attempts to put an end to the mistakes and confusion caused by emergency authorizations to accelerate the use of treatments and vaccines against COVID-19, is much stricter and would include monitoring of clinical trials of the vaccine during, at least two months after the administration of the second dose.

The agency also seeks clear evidence that the vaccine candidates work in severe cases of COVID-19 and in older patients, more than 50% effective compared to those who received the placebo.

The new rules, which will require a new bureaucratic process and longer data collection, make it highly unlikely that some of the candidates will be able to confirm their success before the beginning of November.

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FDA Approves Drug Remdesivir to Treat Coronavirus

Also, the Centers for Disease Control (CDC) have decided to cancel a committee that had planned to decide which groups would be the first to receive the vaccine once it was approved by the regulator, according to the Wall Street Journal reported today.


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