Coronavirus update: Pfizer announces 95% vaccine efficacy, FDA approves at-home test

Anjalee Khemlani
·Senior Reporter
Updated ·4 min read

Pfizer (PFE) is poised to apply for emergency use authorization of its COVID-19 vaccine within days after announcing early Wednesday that the final results of its Phase 3 trial conclude the vaccine is 95% effective.

That puts the pharmaceutical giant, and partner BioNTech (BNTX), at the top in efficacy rankings of vaccine candidates thus far. Rival Moderna (MRNA) announced Monday its vaccine was 94.5% effective— just 0.5% less than Pfizer. In its interim results reading, Pfizer had initially said its vaccine was more than 90% effective.

We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world Pfizer CEO Albert Bourla

The news bodes well for both vaccine companies as well as the U.S., which can expect both to receive emergency use authorization, pending regulatory review by the Food and Drug Administration (FDA).

Pfizer CEO Albert Bourla said in a statement the company will also be applying for approval in other countries.

“We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” he said.

The vaccine proved effective in all age groups, including in the high-risk 65 and older group, and the only major side effects reported were headaches and fatigue, according to Pfizer. The data comes from a first look after the trial met the FDA’s protocol of the number of infected individuals. Of the 170 who were infected, 162 were in the placebo group, indicating the vaccine is largely effective in blocking the virus by comparison.

The data has yet to be released, and a peer review for journal publication will take place once the full analysis is complete. The company expects to produce 50 million vaccine doses for 2020, and up to 1.3 billion by the end of 2021.

If a vaccine is authorized before the end of the year, it will be given to priority individuals first, such as frontline health workers and the elderly. But that isn’t the end of the road, according to Dr. Celine Gounder, an infectious disease specialist in New York City and a member of President-elect Joe Biden’s COVID-19 advisory committee.

“We will continue to collect data on these vaccines, even afterwards,” Gounder said, as the authorization is not a full approval.

Testing delays begin again

Testing has fallen under pressure once again as cases are spiking nationwide.

Daily cases remain above 100,000, pushing the national aggregate to 11.3 million, and deaths are beginning to climb, reaching 248,000 Wednesday. Globally, cases have surged to nearly 56 million and more than 1.3 million have died.

In a statement Tuesday, Quest Diagnostics (DGX) said turnaround times could increase from the two days that have been standard in the past couple of months. The nationwide surge also limits the ability of the company to screen large groups of samples.

“Orders for our COVID-19 molecular testing have increased by approximately 50% compared to the last week of September. The average positivity rate of specimens across our served regions has also increased and is now above 10%, which limits our ability to pool specimens,” Quest said.

Quest said it is adding even more testing equipment to try and manage the influx, but it is also looking at other solutions.

“We also intend to expand our lab referral partner program. And we will continue to strive to provide the fastest testing for priority patients, which includes those who are hospitalized, pre-surgical or receiving care in congregate settings, such as nursing homes,” Quest said.

In an attempt to alleviate this pressure, the FDA has been approving a number of rapid tests — which have mixed accuracy ratings, though they are convenient for point-of-care use— and at-home swab collections. But the FDA also approved the first complete at-home COVID-19 test late Tuesday.

The Lucira All-In-One Test Kit, a molecular test that provides results in about 30 minutes, is authorized for use by prescription only.

U.S. Health and Human Services Sec. Alex Azar said the approval will help increase the ability for Americans to find a test when needed.

“Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options,” he said.

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