Health and Human Services Secretary Alex Azar said on ABC’s “Good Morning America” that the U.S. Food and Drug Administration will grant emergency use authorization to the COVID-19 vaccine developed by Pfizer and German partner BioNTech.
“We could see people getting vaccinated Monday, Tuesday of next week,” Azar said.
The news comes a day after an independent committee voted in an eight-hour public hearing Thursday to recommend authorization.
Mass vaccinations could begin within days for hundreds of thousands of frontline heath care workers and nursing home residents, a potential turning point in the country’s bitter battle against the virus. The vaccine authorization process is taking place as U.S. death toll from the novel coronavirus moves closer to 300,000.
On Thursday, the nation topped 292,000 total deaths from COVID-19, several hundred more than the number of battlefield deaths in World War II, according to the U.S. Department of Veterans Affairs. The U.S. surpassed 3,000 deaths in a single day for the first time on Wednesday, a count higher than the 9/11 terrorist attacks.
I could’ve gone home to my family for Thanksgiving. I’m glad I didn’t: One reporter recounts what it was like to call his mom about his positive COVID test amid a holiday gathering.
? Today’s numbers: The U.S. has reported nearly 15.6 million cases and more than 292,000 deaths, according to Johns Hopkins University data. The global totals: 69.6 million cases and more than 1.5 million deaths.
? What we’re reading: It may not have started here, but the novel coronavirus became a U.S. tragedy. In the earliest days of a historic pandemic, the virus had unfettered access into and throughout the country.
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Sanofi and GSK announce delay in its COVID vaccine as older people fail to show immune response
Sanofi and GlaxoSmithKline (GSK) announced Friday a delay in their COVID-19 vaccine program after study results found older patients failed to demonstrate a sufficient immune response against the virus.
The companies said in a joint statement the low immune response was likely due to an insufficient concentration of the antigen. Phase 1/2 trial interim results showed participants between 18 and 49 years old showed an immune response comparable to patients who recovered from COVID-19.
“The results of the study are not as we hoped,” Roger Connor, president of GSK Vaccines, said in the press release. “Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to make a meaningful contribution to prevention COVID-19.”
French company Sanofi and U.K.-based GSK said a Phase 2b study with the improved vaccine will start in February 2021 and will be available to the public by the end of next year pending its success.
- Adrianna Rodriguez
HHS Secretary Azar says Pfizer vaccine will get FDA authorization
Health and Human Services Secretary Alex Azar said on ABC’s “Good Morning America” the U.S. Food and Drug Administration will grant emergency use authorization to Pfizer COVID-19 vaccine and expects Americans could start getting vaccinated as soon as next week.
“We could see people getting vaccinated Monday, Tuesday of next week,” Azar said.
The news comes a day after the independent Vaccines and Related Products Advisory Committee voted in an eight-hour public hearing Thursday to recommend authorizing the vaccine made by Pfizer and its partner BioNTech called BNT162b2.
Other countries have already approved the vaccine, including Canada and the United Kingdom, with the latter already rolling out the first doses and vaccinating its population.
The FDA’s thorough review has prompted some backlash from President Donald Trump, who called the agency “a big, old slow turtle,” in a tweet Friday morning.
“Get the dam vaccines out NOW, Dr. Hahn… stop playing games and start saving lives!!!” he tweeted.
– Adrianna Rodriguez
Stark numbers show COVID’s vice-like grip on the US
The United States has now reported more deaths from COVID-19 than combat deaths in World War II. Johns Hopkins University shows 291,929 coronavirus deaths, several hundred more than the U.S. Department of Veterans Affairs says were lost in battle in World War II. South Dakota on Thursday became the second state to have 1 of every 10 of its people test positive, Johns Hopkins University data shows. North Dakota hit that mark on Thanksgiving.
The place with the most cases per person is Crowley County, Colorado, where about 22.7 percent of the people have tested positive, Johns Hopkins University says. Most of those cases came in a month. Additionally, a county in Hawaii became the United States’ final county to have a resident test positive for COVID-19, the Maui News reported Thursday. In the last month, the U.S. has seen more deaths from COVID-19 (51,518) than battle deaths from Vietnam (47,434).
– Mike Stucka
Leaked reports: Feds secretly pulled toy police from ports amid COVID
The federal safety inspectors who protect kids from dangerous and deadly toys were not standing guard for nearly six months while this year’s holiday gifts entered the U.S. by the shipload due to the threat of COVID-19. Princess palaces and playhouses, water guns and tricycles landed on store shelves and front doorsteps without the usual security checks for lead, chemicals or choking hazards.
The Consumer Product Safety Commission pulled its inspectors from ports around the country in mid-March because of the threat of COVID-19. Leaders of the federal agency made the decision in private, without a warning to consumers or full disclosure to Congress, then continued the shutdown at the ports and a government testing laboratory until September, USA TODAY has found. That included spring and summer months that were their inspectors’ busiest last year. Read more.
– Letitia Stein and Brett Murphy
Key committee endorses Pfizer vaccine for FDA authorization
A committee of leading U.S. vaccine scientists recommended Thursday that the Food and Drug Administration authorize the first COVID-19 vaccine for Americans. The endorsement paves the way for a final decision by the FDA.
Mass vaccinations may begin within days in thousands of frontline heath care workers and nursing homes residents.
After a day-long public hearing, the independent Vaccines and Related Biological Products Advisory Committee voted 17 to 4, with 1 abstention, to recommend the vaccine made by Pfizer and its partner BioNTech called BNT162b2. The FDA is expected to clear the vaccine for emergency use as early as Friday. Once it authorized, it will begin shipping to all 50 states.
– Elizabeth Weise and Karen Weintraub
Will the vaccine be required? Any side effects? USA TODAY answers questions
More than 2,000 reader questions have been submitted to USA TODAY in the past two weeks as a vaccine rollout inches ever closer. USA TODAY’s editor-in-chief Nicole Carroll rounds some of them up in her latest column:
Yes, it is safe. The approval process for vaccines is stringent and heavily reviewed. The FDA on Tuesday released a 53-page report summarizing data from Pfizer/BioNTech’s COVID-19 candidate vaccine trial.
What are potential side effects? All three vaccine makers have reported mild to moderate reactions, including pain at injection site, fatigue and sore muscles and joints. Doctors say this is normal.
The vaccine itself will be free, but health care providers can charge a fee for administering it, which can be paid for by insurance or a government relief fund.
The vaccines require two doses, and they must be from the same manufacturer, as the composition and timing of vaccines differ.
It is not known if you can still get sick or spread the virus to others after you’ve been vaccinated. However, the vaccines are at least 95% effective. It’s not known yet how long the vaccination lasts.
The vaccines weren’t tested on children, so school-age kids won’t be getting vaccinated at first. But college students are eligible, and colleges are debating whether they will, or when they will, be required.
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Boston Biogen conference was likely superspreader, study says
A study published Thursday suggests 205,000 to 300,000 COVID-19 cases across the U.S. and globally can be traced back to a two-day Boston conference.
The Biogen conference, held Feb. 26-27, is responsible for roughly 1.6% of all U.S. cases since the start of the pandemic, researchers estimated.
The study says that the conference is an example of what happens when the virus spreads unchecked, as the outbreak likely created “major outbreaks among individuals experiencing homelessness, spread[ing] throughout the Boston area including to other higher risk communities, and were exported to other domestic and international sites.”
Missouri police chief: ‘No more warnings’ for mask deniers
A Missouri police chief has vowed to crack down on people who refuse to wear face coverings following an informational campaign to curb the spread of the coronavirus.
“Writing a citation has always been an option… but we’ve taken a primarily ‘education and warning’ approach,” Springfield Police Chief Paul Williams told Ozarks First on Thursday.
But with compliance plateauing about 90%, and cases on the rise, Williams said it’s time to penalize offenders.
“No more warnings. No more pamphlets being handed out,” Williams said. “We’re really encouraging officers to take that next step and write the citation, as provided for in the ordinance.”
Williams said people can “have their day in court” if they choose to fight the citation.
New Hampshire House Speaker Dick Hinch dies of COVID-19
The speaker of the New Hampshire House of Representatives died of COVID-19, a medical examiner ruled Thursday, a day after the Republican’s unexpected death, raising concerns that other members of one of the world’s largest legislative bodies might have been exposed at their swearing-in last week.
Dick Hinch, who was sworn in Dec. 2 as leader of the state’s newly Republican-led, 400-member Legislature, died Wednesday. He was 71 and had been starting his seventh two-year term in the state House.
His death was announced Wednesday night by his office, which did not give details of what it called “this unexpected tragedy.”
Every US county has now had at least one COVID-19 case
An adult resident of Kalaupapa, Hawaii, has become the first person to contract COVID-19 in Kalawao County, reportedly the last county in the U.S. without a case in eight months of the pandemic, according to the Hawaii Department of Health, the Maui News said.
The person received a positive test result after returning on a local flight to Kalaupapa and is now in self-isolation with no symptoms.
Ellen DeGeneres tests positive but ‘feels fine’
Ellen DeGeneres has tested positive for COVID-19 but is “feeling fine right now,” she announced Thursday. Production on “The Ellen DeGeneres Show” has been paused until January, a Telepictures spokesperson confirmed to USA TODAY. The television host, 62, said in a tweet that “anyone who has been in close contact with me has been notified, and I am following all proper CDC guidelines.” In October, “The Ellen DeGeneres Show” became one of the first TV productions to return to inviting a limited number of in-studio audience members. On Oct. 28, 40 fans attended the “Ellen” taping in person in a studio generally holds about 300.
“I’ll see you all again after the holidays,” DeGeneres said. “Please stay healthy and safe.”
