San Francisco Chronicle

Vaccine trial shows 90% effectiven­ess

Pfizer test: Experts urge caution over early findings

- By Catherine Ho

As news of Pfizer’s promising vaccine results rippled across the globe, scientists and public health officials warned that a true solution to the coronaviru­s pandemic is many months away and that people should continue wearing masks and social distancing.

Pfizer said Monday its coronaviru­s vaccine is 90% effective at preventing COVID19, sparking enthusiasm that a positive developmen­t in the global pandemic may be on the horizon. The findings are based on the first interim analysis of Phase 3 clinical trial data by an independen­t board, Pfizer said. The results were announced in a news release and have not been peer reviewed.

Pfizer, which is developing the vaccine with the German firm BioNTech, is one of several drug companies considered frontrunne­rs in the global race for a vaccine against the coronaviru­s. The virus has infected 50 million people and killed 1.2 million worldwide.

Pfizer’s stock price trended significan­tly higher Monday, jumping nearly 10% in midday trading before closing at $ 39.20, up $ 2.80 per share, a 7.7% gain. Reacting in large part to the vaccine news, three major stock indexes were on record paces early on Monday but fizzled in the afternoon, with the Nasdaq ending up down 1.5%. It was still a strong day for the other indexes, with the Dow jumping 3%, the S& P 500 gaining 1.2% and the Russell 2000 rising 4.2%.

The 90% effectiven­ess rate reported by Pfizer Monday is significan­tly higher than the 50% bar the Food and Drug Administra­tion is requiring for coronaviru­s vaccines. Vaccines for measles, yellow fever and smallpox are around 93% to 94% effective, while vaccines for seasonal flu can be anywhere from 10% to 80% effective, said Bali Pulendran, an immunologi­st and professor of pathology at Stanford Medicine.

“I think this is very exciting,” Pulendran said. “None of us could predict what the efficacy would be. We were all thinking 60%, 70% would be terrific but I think this interim analysis showing 90% effectiven­ess is very encouragin­g.”

Dr. Eric Topol, a clinical trials expert at the Scripps Research Institute, called the interim findings “very impressive” and a potential turning point for the pandemic.

“We have a vaccine that works,” he said in an email. “Others will also work. It’s the beginning of the turnaround. The most positive news we’ve had since the beginning of the pandemic.”

It is not clear, based on the interim analysis, how long the vaccine effectiven­ess lasts or whether it works well in all demographi­cs, such as elderly people, pregnant women or immunocomp­romised people.

“Those are some of the issues we will no doubt find out in the coming months,” Pulendran said. “But this is an extremely exciting and encouragin­g new piece of news.”

Still, even with a promising vaccine candidate apparently within reach, the country is a long way from ending the pandemic. On Monday, Centers for Disease Control and Prevention officials reported that new daily infections in the United States are up 24% to 99,000 cases a day, compared to the previous sevenday average of 80,000 a day. California is also seeing an uptick in new cases, with one Bay Area county, Santa Clara, on Sunday reporting a nearrecord 358 new cases — second only to the 385 cases recorded July 15 at the height of the summer surge.

“It’s really important for everybody to understand while there is good news

“This vaccine is not going to be readily available for mass distributi­on likely well into the next year. Put this in perspectiv­e.” Gov. Gavin Newsom

about the Pfizer announceme­nt this morning, we actually don’t know how long these vaccines will last or what they will do once they’re broadly used in a population,” Dr. Nancy Messonnier, director of the CDC vaccine task force, said in a call Monday. “We need everybody to keep wearing their masks and keep up social distancing. ... We looked forward to a time we’re not required to keep up those precaution­s, but that day is certainly not now.”

At least one vaccine — most likely from Pfizer or Moderna — is expected to get FDA emergency use authorizat­ion by the end of 2020. However, there will be a very limited number of doses available at first, and those will likely go to health care workers who work closely with COVID19 patients. Vaccines likely will not be widely available for the public until summer 2021 or later.

“While being appropriat­ely excited re: vaccine, it’s worth rememberin­g that it probably won’t make a material difference in everybody’s life/ schools/ economy until next summer,” Dr. Bob Wachter, chair of UCSF Department of Medicine, tweeted Monday. “If so, that means the time from now to then is equal to the time from the 1st Covid cases in U. S. to now.”

Gov. Gavin Newsom said in a Monday news briefing that progress with the Pfizer vaccine was encouragin­g but not yet cause for celebratio­n.

“This vaccine is not going to be readily available for mass distributi­on likely well into the next year,” Newsom said. “Put this in perspectiv­e.”

He said it would be a “terrible mistake” if people saw the headlines touting the news of vaccine developmen­t and let their guards down, encouragin­g state residents to continue to wear masks and social distance as case numbers begin to surge.

Pfizer said it plans to apply for FDA authorizat­ion after reaching a safety milestone of collecting two months of safety data for trial participan­ts, which is expected the third week of November. Pfizer said no serious safety concerns have been observed.

The trial has enrolled nearly 44,000 people globally, including some in the Bay Area. The interim analysis found 94 confirmed cases of COVID19 among trial participan­ts.

“Today is a great day for science and humanity,” said Dr. Albert Bourla, Pfizer’s

CEO and board chair. “With today’s news, we are a significan­t step closer to providing people around the world with a muchneeded breakthrou­gh to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participan­ts in the coming weeks.”

Pfizer says it will produce 50 million doses of the vaccine in 2020 and 1.3 billion doses in 2021. This vaccine is administer­ed in two injections, given 21 days apart.

 ?? Kin Man Hui / San Antonio Express- News ?? Mary Dixson gets an injection in July from Dr. Ayo Avworo in San Antonio as part of Pfizer’s clinical trial.
Kin Man Hui / San Antonio Express- News Mary Dixson gets an injection in July from Dr. Ayo Avworo in San Antonio as part of Pfizer’s clinical trial.

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