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Vaccines for the novel coronavirus: How they are approved, who would get one first and other key things to know

A vaccine could mean a turning point in the fight against a novel coronavirus that has infected at least 7.8 million people in the United States, killed more than 214,000 nationwide and unraveled aspects of most everyone’s lives.

But approving a vaccine quickly is complex. And distributing it to some 330 million Americans, and to other countries, will require a feat of logistics.

Here’s what you need to know about the COVID-19 vaccine effort.

What’s the timeline?

It depends on two main factors: how long the vaccines take to develop and get approved, and how quickly they can be manufactured and distributed.

Experts say multiple vaccines are needed to immunize the U.S. population. Clinical trials on several vaccine candidates could soon have produced enough data to assess whether they’re effective.

Moderna and Pfizer are farthest along, with vaccines deep into phase 3 clinical trials involving tens of thousands of people, according to Moncef Slaoui, the scientific head of Operation Warp Speed, a federal program working toward immunizing Americans as quickly as possible.

Both are mRNA vaccines, which introduce genetic code for viral antigens that could teach the body’s immune system to respond to the virus. This new platform has yet to produce an approved vaccine of any kind. 

Slaoui, who spoke Oct. 6 at a virtual event co-hosted by the University of Washington and Johns Hopkins University, said he expected “efficacy outcomes” — data on whether the vaccines work — within the next seven weeks.

The federal government also is investing in three other platforms besides mRNA, including adenovirus-based vaccines and adjuvanted protein vaccines, which could reach efficacy sometime next year.

Scaling up the manufacture of vaccines is “equally important and, frankly, even more complicated” than clinical development of them, Slaoui said. He discouraged vaccine makers from filing for emergency approval until their vaccines are available to distribute.

The mRNA vaccines already are being stockpiled, pending trial results and regulators’ approval.

Slaoui said he felt comfortable that within two months, one or both mRNA vaccines would reach efficacy and would have enough already stored to vaccinate 30 million Americans by year’s end and 50 million more in January. 

That’s an optimistic timeline.

Dr. Robert Kadlec, Health and Human Services (HHS) Assistant Secretary for Preparedness and Response, said the U.S. can expect vaccine delivery starting in January.

And Dr. Anna Wald, a UW professor of medicine, epidemiology and laboratory medicine, said that even if limited quantities are shipped later this year, she didn’t expect vaccines to impact the pandemic’s course until spring 2021.

“Why don’t we wait and do it right?”
— Dr. Larry Corey

Because the trials are so large, data accumulates quickly, and scientists stand to learn more about how effective the vaccines are the longer they wait to review results, said Dr. Larry Corey, former director of the Fred Hutchinson Cancer Research Center and co-leader of a national network coordinating clinical trials on vaccines.

“We will learn a hell of a lot more” by waiting until December, Corey