FDA Meeting 9 Hours Discuss Permit for Emergency Use of Covid-19 Vaccines
, Jakarta - The Vaccines and Biological Products Advisory Committee (VRBPAC) at the United States Food and Drug Administration ( FDA) is involved in a nine-hour virtual meeting discussing permits for the wide-scale use of the Covid-19 vaccine with only minimal evidence of efficacy and safety. Emergency use authorization (EUA), a term that has recently become popular, can only use preliminary data from clinical trials of vaccines.
Because it would cut the months-long process of awarding standard approvals, the bypass policy was left by the FDA to VRBPAC for pros and cons.
The hearing meeting, which can be attended via YouTube, is attended by committee members consisting of academics, consumer representatives and government scientists. They argue tough but send a pretty clear message to the FDA: hold back.
Some VRBPAC members are concerned that granting emergency permits could contribute to growing public doubts about the Covid-19 vaccine. This is because there is a growing perception that the FDA has compromised its well-known high standards.
Sheldon Toubman, a lawyer representing consumer interests on the committee, called on the FDA not to issue an EUA for the Covid-19 vaccine . The reason is that the FDA must stick to existing approval procedures to avoid increasing the problem of the public's lack of trust in vaccines.
"There's only one chance to do it right," he said at the meeting on Thursday, October 22, 2020. He added, "And if we do it wrong, then it will be all over for the next few years that makes it difficult for us to get out again."