Pfizer, partner ask FDA for green light on vaccine
Pfizer and its German partner BioNTech applied Friday for emergency authorization of their coronavirus vaccine, a landmark moment and a signal that a powerful tool to help control the pandemic could begin to be available by late December.
The U.S. race to develop a vaccine has set scientific speed records since it launched in January, and the submission of a first application to regulators cements that. Now, that effort will move to its next, deliberative phase — a weeks-long process in which career scientists at the FDA scrutinize the data and determine whether the vaccine is safe and effective to be used in a broad population.
“It is with great pride and joy, and even a little relief that I can say our request for emer
gency use authorization for a covid-19 vaccine is now in the FDA’s hands,” Pfizer Chief Executive Albert Bourla said in a video message shared by the company. “This is a historic day — a historic day for science and for all of us.”
Only after the FDA has given the green light will a first, limited group of highrisk people be able to access the shots. Government officials anticipate having enough vaccine to inoculate about 20 million people with the two-dose regimen in the United States in December, between Pfizer and BioNTech’s vaccine and a second shot likely to be considered for emergency authorization soon, from biotechnology company Moderna. The United States will receive about half of the 50 million doses Pfizer is aiming to produce by the end of the year.
There will probably be enough vaccine for 25 million to 30 million people a month in early 2021, said Moncef Slaoui, chief scientific adviser of Operation Warp Speed, the federal government initiative to speed up vaccine development. He did not specify how many doses each company would contribute.
Glimpses of the Pfizer data through news releases have so far exceeded expectations: The two-dose vaccine regimen was 95% effective at preventing disease in clinical trials and had no major safety problems, according to the company. It was 94% effective in people older than 65, a group of critical concern because older people are more likely to develop life-threatening illness after contracting the virus.
The companies are also submitting two months of follow-up data on 38,000 people of the 44,000 in the trial. They will present safety data on 100 children between 12 and 15, a group they only recently began to include in their trial.
Those findings will be scrutinized by regulators — including at a full-day advisory committee meeting in which external scientists will meet to make recommendations to the agency on whether it should clear the vaccine for broader use.
The companies have started applications that are updated continuously with other regulators, including those for the European Union and the United Kingdom. The drugmakers said they will submit applications in other countries within days. They are poised to distribute the first doses of vaccine within hours of a regulatory decision.
WORRIES PERSIST
The hope that many scientists and physicians feel about unprecedented scientific success in developing an effective vaccine has been tempered by a grim reality. No vaccine will arrive in time to alter the current surge of virus, as hospitals are overwhelmed, testing capacity is stretched and intensive care units fill with sick people — right before holidays that may seed even more outbreaks.
“My message to the American people is to hang in there with us. Take the simple steps that the doctors have talked about today because there is a light at the end of the tunnel. This isn’t forever,” Health and Human Services Secretary Alex Azar said in a briefing Thursday.
On Wednesday, Pfizer announced its 44,000-person vaccine trial had hit the necessary endpoints for safety and efficacy and that it could file for emergency authorization within days. The vaccine was 95% effective at preventing disease in the large clinical trial, and Pfizer and BioNTech
had gathered sufficient safety data to support an application, with no major safety problems identified.
Half of the participants in Pfizer’s trial received two doses of the study vaccine, and half received two shots of saline. Then, the investigators waited to see which participants fell ill as they were exposed to the virus in their normal lives.
Out of 170 cases of covid-19 so far, 162 were in the placebo group — a strong signal that the vaccine protected people. Nine in 10 cases of severe illness were in the placebo group, another strong sign the vaccine protected against mild and serious cases. The most common adverse event rated as “severe” in the trial was fatigue, in 3.7% of participants after the second dose.
An emergency authorization for a vaccine is typically a lower standard than full approval. Still, FDA guidelines sought to set a high standard for a vaccine, even under emergency authorization. That guidance required a vaccine be at least 50% effective, with a minimum of two months of safety data on half the participants.
INFECTIONS RELENTLESS
The overall U.S. death toll has reached about 254,000, by far the most in the world. Confirmed infections neared 11.9 million, after the biggest oneday gain on record Thursday — almost 188,000. And the number of people in the hospital with covid-19 hit another alltime high at more than 80,000.
With health experts deeply afraid Thanksgiving travel and holiday gatherings next week will fuel the spread of the virus, many states and cities are imposing near-lockdowns or other restrictions. California ordered a 10 p.m.-to 5-a.m. curfew starting Saturday, covering 94% of the state’s 40 million residents.
The Texas border county of El Paso, where more than 300 people have died from covid-19 since October, is advertising jobs for morgue workers capable of lifting bodies weighing 175 pounds or more. Officials are offering more than $27 an hour for work described as not only physically arduous but “emotionally taxing as well.”
The county had already begun paying jail inmates $2 an hour to help move corpses and has ordered at least 10 refrigerated trucks as morgues run out of room.
Covid-19 deaths in the U.S. are at their highest level since late May, when the Northeast was emerging from the first wave of the crisis. They peaked at about 2,200 a day in late April, when New York City was the epicenter and bodies were being loaded onto refrigerated trucks by forklift.
Among the newly infected was President Donald Trump’s eldest son, Donald Trump Jr., who a spokesman said Friday has no symptoms and has been quarantining since learning of his diagnosis this week.
Efforts to slow the spread of the coronavirus in Oklahoma are “too little, too late” and hospitalizations in the state are likely to continue rising, a University of Oklahoma medical center doctor said Friday.
“I think some of the new restrictions that have been put into place may have some benefit for reducing spread of the disease, but quite honestly … I think it’s too little, too late right now,” said Dr. Dale Bratzler of the University of Oklahoma.
Bratzler said anything to mitigate the virus’s spread helps, but that it will take two to three weeks for restrictions to reduce infections, and hospitalizations are likely to reach 2,000 to 3,000 during that time.
The state health department reported 1,428 hospitalizations Friday after reporting a one-day record of 1,434 on Wednesday.
On Thursday, Gov. Kevin Stitt implemented measures including a mask mandate in state buildings and closing bars and in-person restaurant service at 11 p.m.
The department reported 2,915 new cases and 18 additional deaths due to the virus for totals of 164,340 cases and 1,588 deaths since the outbreak began.
COLLEGE CONCERNS
Meanwhile, as college students prepare to go home for the holidays, some schools are quickly ramping up covid-19 testing to try to keep infections from spreading further.
Thousands of cases have been connected to campuses since some colleges reopened this fall, forcing students to quarantine in dorms and shifting classes online. Now, many students are heading home for Thanksgiving, raising the risk of the virus spreading among family, friends and other travelers.
“The responsibility and the reach of the impact is not just to the student body anymore, it’s to those close contacts,” said Emily Rounds, a student who helps collect data on college testing plans nationwide for the Crisis College Initiative at Davidson College.
Colleges’ pandemic plans vary widely. About one-third of four-year colleges started primarily in person this fall, the initiative’s researchers found as they tracked about 1,400 schools.
Only about 100 colleges initially tested all students once or twice a week, regardless of symptoms, as part of their back-to-school plans. Many more tested random samples of students or tested those with symptoms — neither of which is considered enough to stop the spread of the disease, said Christopher Marsicano, an education professor at Davidson who founded the project.
Since early November, though, the researchers have seen a noticeable uptick in schools requiring or encouraging students to get tested before Thanksgiving. For many colleges, the holiday marks the end of in-person learning for the year, whether moving classes online was always the plan to keep students from bringing the virus back to campus or it became the response to soaring infections nationwide.
Some colleges are turning to states for help paying for the extra tests, while others are relying on those developed by their own researchers.
The University of Notre Dame announced a testing mandate after thousands of football fans, many without masks, stormed the field in South Bend, Ind., and threw parties to celebrate a double-overtime upset over Clemson this month. Those who don’t complete the test can’t register for future classes.
Vanderbilt University in Nashville, Tenn., has a similar requirement, as does the public university system in New York.