FDA may give quick OK for virus vaccine

The number of novel coronavirus cases reported in the United States passed 6 million on Monday — with at least 183,000 dead — as the head of the Food and Drug Administration (FDA) said he is willing to bypass the normal approval process and give emergency authorization for a COVID-19 vaccine as soon as possible.

Dr Stephen Hahn told the Financial Times in an interview that his agency was prepared to authorize a vaccine before phase three clinical trials were complete, as long as health officials believed the benefits outweighed the risks.

But Hahn insisted he wouldn't rush a vaccine to please President Donald Trump amid reports that Trump wants a vaccine to be available before November's election to help improve his chance of victory.

"Science and data drive our decisions," Hahn said. "We have terrific, terrific scientists, doctors, nurses, pharmacists. They make the decisions on the ground … and they're science driven. We need to make sure that the American people know that and have confidence in that."

Former FDA chief Scott Gottlieb said Sunday on CBS' Face the Nation that the emergency authorization could allow use of the vaccine for high-risk populations.

"Full approval for the general population, where people can go to CVS and get a shot, that's really a 2021 event," Gottlieb said. "Maybe the first quarter of 2021, probably more likely the first half.

The chief scientist at the World Health Organization (WHO), Soumya Swaminathan, on Monday warned that while countries have the right to use emergency authorizations to approve vaccines without full trials, "it is not something that you do lightly".

British drugmaker AstraZeneca announced Monday it has started phase three trials of its coronavirus vaccine candidate in the US. It is the third vaccine to enter large-scale trials in the country after vaccines made by Moderna and Pfizer-BioNTech.

For the US trial, AstraZeneca said that that it is "recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus".

The number of confirmed US coronavirus cases on Monday was 6,026,488 with 183,488 deaths, according to data from Johns Hopkins University. The US Centers for Disease Control and Prevention (CDC) now projects 200,000 COVID-19 deaths by Sept 19.

One of President Trump's top medical advisers, Dr Scott Atlas, on Monday denied a Washington Post report that he is urging the White House to embrace a "herd immunity" strategy to combat the pandemic.

"There is no policy of the president or this administration of achieving herd immunity. There never has been any such policy recommended to the president or to anyone else from me," Atlas said in a statement.

The herd immunity approach calls for allowing the coronavirus to spread through the population to quickly build resistance to the virus while taking steps to protect vulnerable populations, as in nursing homes.

The Post cited five unidentified people it said are familiar with discussions at the White House about implementing the herd immunity approach.

"That this approach is even being discussed inside the White House is drawing concern from experts inside and outside the government who note that a herd immunity strategy could lead to the country suffering hundreds of thousands, if not millions, of lost lives,'' the newspaper said.

Atlas, a neuroradiologist with Stanford University's conservative Hoover Institution, joined the White House earlier this month as a pandemic adviser.

Meanwhile, coronavirus infections in the US over the past week have increased in the Midwest, including Iowa, Kansas, Nebraska, Minnesota and the Dakotas.

California on Monday become the first US state to record more than 700,000 confirmed coronavirus cases, although the number of new cases posted Monday was the lowest in more than 10 weeks.

California reported 4,176 additional coronavirus infections Monday, bringing California's total since the pandemic began to 704,085. There have been 12,933 deaths attributed to the virus, up 28 versus the prior day.

Iowa averaged about 500 cases a day until last week, when daily totals rose to more than 1,000 cases for several days straight. Outbreaks at the University of Iowa and Iowa State University are probably major contributing factors, epidemiologists say.