Manufacture Of Coronavirus Vaccine To Begin Within Weeks, Senior Administration Official Says

KEY POINTS

The federal government has spent more than $4 billion so far on the development of a coronavirus vaccine and therapeutics

It was unclear what impact a UK study showing antibody protection is fleeting will have on the approach

There are four vaccine candidates federal officials say are promising and deals are underway for other options

A senior Trump administration official said Monday the government expects manufacture of a coronavirus vaccine to begin within four to six weeks so that hundreds of millions of doses will be available before phase 3 trials are complete.

In the meantime, a Food and Drug Administration official urged people who have recovered from the coronavirus infection to donate blood plasma for use in treating those suffering from COVID-19.

The federal government has invested nearly $4 billion in what are believed the most promising candidates, the official told a conference call with reporters, and deals for other candidates are in the works.

Contracts have been announced for vaccines under development by Johnson & Johnson ($456 million), Moderna ($483 million), Astra Zeneca ($1.2 billion) and Novavax ($1.6 billion). The vaccines employ several approaches: messenger RNA, adenovirus and proteins.

Regeneron has received $450 million from the government to support clinical trials of its REGN-COV2 antibody cocktail while the federal government has secured most of Gilead’s complete production run of its antiviral remdesivir.

“We believe we will have new options for saving Americans this fall” without lowering regulatory standards, the official told reporters. “We feel very confident by yearend we will have tens of millions of doses of vaccine. … Once the FDA gives approval, we want to start shipping and distributing.”

He said equipment and supplies already are being delivered to speed the manufacturing process.

The official said both vaccine and therapeutic candidates were chosen based on four criteria: promising science, stage of development, evidence that manufacture could scale up rapidly and whether the treatment or vaccine was likely to succeed.

It was unclear what impact a study released Monday by U.K. researchers indicating antibody protection fades quickly would have on the approach.

Dr. Janet Woodcock, director of the center for drug evaluation and research at the FDA and who is leading the effort to develop therapeutics, said though the hope is that treatment with monoclonal antibodies will prove effective, a national awareness campaign needs to be launched for the collection the convalescent plasma. She said plasma collected so far has not been tested to determine how much protection is provided.

“With so many people infected [across the West and South], we can speed enrollment. These are high quality registration trials” and there will be no “cutting corners on the evidence,” Woodcock said.

Clinical trials for monoclonal antibodies will include both single antibodies and antibody cocktails. Therapeutic studies are complicated by the number of scenarios created by the disease from patients who show no symptoms to those hospitalized with cytokine storms and blood clots.

The senior administration official said hospitals are moving toward daily reporting of cases to enable the government to allocate supplies of both plasma and therapeutics effectively.