US may tighten COVID-19 vaccine requirements

By | September 23, 2020
US may tighten COVID-19 vaccine requirements

The Food and Drug Administration (FDA) may soon tighten emergency approval requirements for COVID-19 vaccines, delaying vaccine development in the United States, the Washington Post reported.
New conditions for emergency approval are expected to include observation of participants in the last phase of a vaccine trial for at least two months after receiving a second dose, as well as a regulatory review of at least five severe COVID-19 cases in the placebo group and cases among the elderly. It was previously noted that the vaccine should be at least 50% more effective than a placebo.

It is noted that innovations will be announced in order to increase the openness of the authorities and build confidence in coronavirus vaccines in the population.
Once the new rules are announced, it is expected that it will be unlikely that the vaccine will be available in the United States before the November 3 presidential election, as authorities had previously anticipated.
“It’s hard to imagine how (emergency approval) it could happen before December,” FDA vaccine advisory board member Paul Offit said.
vaccine requirements
The new requirements may be announced this week.
Several coronavirus vaccines developed by companies such as Moderna, Pfizer, and AstraZeneca are being clinically tested in the USA. Earlier, President Donald Trump said that the COVID-19 vaccine could be ready in the U.S. by presidential election day on November 3. Stephen Khan, head of the U.S. Food and Drug Administration (FDA), told the Financial Times that he is ready to approve the coronavirus vaccine before the end of Phase 3 of clinical trials if the benefits exceed possible risks.
Earlier, the New York Times reported that the U.S. Centers for Disease Control and Prevention (CDC) had asked states to prepare for Coronavirus vaccine distribution in late October or early November. Political opponents of Republican President Trump then accused the administration of trying to artificially speed up vaccine preparation before elections. U.S. chief infectious disease officer Anthony Fauci also expressed skepticism about the possible spread of the vaccine in November.