Federal health advisers predict four US-backed coronavirus vaccine trials could fail


A senior group briefing U.S. health officials predicted on Tuesday that four U.S.-backed advanced coronavirus vaccine trials may not yield positive results.The National Academies of Science, Engineering, and Medicine have released a draft report that outlines a federal plan for distributing a coronavirus vaccine in the United States if and when it is approved for public use. The vaccine would be distributed in four phases to healthcare workers and vulnerable Americans, such as the elderly and people with underlying health conditions, first.

The group said it expects all volunteers participating in vaccine trials in the United States to quickly obtain an approved vaccination regardless of its stepwise guidelines, because “this is a typical standard of the trial protocol of vaccine ”. He said the Trump administration’s Operation Warp Speed ​​expects to support up to seven phase three trials of 30,000 people and assumes four of them will fail.

“Four of the trials will fail and all subjects in those trials will have access to an approved vaccine,” the group wrote in the draft report. “Three of the trials will be successful and, at a 1: 1 ratio between members of the treatment groups versus the placebo group, 15,000 participants in each of these trials who have been assigned the placebo condition will be offered and approved for the vaccine. . ”

According to a study published in the scientific journal Biostatistics, vaccines against infectious diseases have a 33.4% success rate through clinical trials and regulatory approval.

In phase three trials, vaccines are typically given to thousands of people and tested for effectiveness and safety, according to the Centers for Disease Control and Prevention.

The United States, as part of Operation Warp Speed, has already invested billions of dollars in six potential vaccines last month, including pharmaceutical companies Pfizer, Moderna and AstraZeneca, which have all entered phase trials. three.

Some candidate vaccines are in the process of being manufactured prior to regulatory approval. Due to the pandemic, US health officials have accelerated the development of vaccine candidates by investing in several stages of research, although it could be pointless if the vaccine ends up being ineffective or safe.

U.S. health officials have said they are optimistic that they will find at least one safe and effective vaccine by the end of the year and possibly more than one by early 2021.

Although it is hoped that scientists will find a safe and effective vaccine, there is never a guarantee, say the scientists. They warn that questions remain about how the human body reacts once it has been infected with the virus.

For example, scientists expect antibodies to provide some degree of protection against Covid-19, but they cannot yet say definitively since the discovery of the coronavirus about eight months ago.

Researchers in Hong Kong reported last month what appears to be the first confirmed case of re-infection with Covid-19, a man who was first infected with the virus at the end of March then, 4 months and half later, seems to have contracted the virus again.


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