Doses for three vaccines are ready for distribution following an FDA approval, as health experts raise concern over emergency authorization.
Already manufactured in thousands, the vaccines are ready for distribution on receiving clearance from the Food and Drug Administration. Each late-stage study will have to enroll at least 30,000 individuals and show that 50 percent of its participants are protected from contracting COVID-19 for six months to get the federal agency's approval.
Meanwhile, the National Academies of Sciences, Engineering, and Medicine, an advisory panel, released a draft plan this week proposing how the first vaccine doses should be distributed. With the initial supply expected to be limited to 15 million people, the panel proposed giving the first doses to high-risk health care workers and first responders, followed by older residents of nursing homes and other crowded facilities. Constituted by a group of top health officials, the panel said Operation Warp Speed could spend on up to seven phase three trials, from which at least four would fail.
As three vaccines head into final stages of the trial, FDA Chief Stephen Hahn told Financial Times he would consider granting a vaccine emergency authorization before the full completion of phase three testing. While Hahn said expediting the approval process will be measured and not under pressure from the Trump administration ahead of November's elections, health experts say the vaccine should be put through a complete testing process. Concerns over increasing vaccine hesitancy combined with ensuring full assessment of its side effects and efficacy are being raised.
Additionally, the Center for Disease Control and Prevention's directive to states to speed up approval for vaccine distribution sites by November 1 has caused additional concern in the scientific community. Some vaccine experts say a clinical trial can typically take between eight to 12 months and are accusing the White House of politicizing a public health crisis ahead of November 3 elections, according to the New York Times.
The COVID-19 pandemic has given rise to a lot of potentially dangerous misinformation. For reliable advice on COVID-19 including symptoms, prevention and available treatment, please refer to the World Health Organisation or your national healthcare authority.