Pfizer and German partner BioNTech plan to submit for approval their COVID-19 booster shot to the Food and Drug Administration this week for people over the age of 16, the companies said in a joint statement Wednesday.
Phase 3 trial data shows a third dose of their vaccine – called Comirnaty – produced more than three times the neutralizing antibodies against the coronavirus compared to a second dose, the companies said.
A booster shot has not been authorized in the U.S. for broad use. However, the FDA authorized a third dose of Pfizer’s vaccine for people 12 or over who had undergone organ transplantation, or who are diagnosed with conditions that make them immunocompromised.
The announcement comes just days after Pfizer-BioNTech’s COVID-19 vaccine became the first to earn FDA approval for people 16 and older, eight months after it received emergency use authorization.
Johnson & Johnson also said Wednesday studies show a booster dose of its vaccine offered a ninefold increase in antibodies compared with the vaccine on its own.
The company said it was working with federal officials, including the FDA and Centers for Disease Control and Prevention, on next steps to boost the effects of the vaccine and ready a possible booster shot.
A CDC study released Tuesday showed protection from the vaccines may decline over time as the delta variant surges across the country. Once delta became the dominant strain in the U.S., vaccine effectiveness against infection decreased from 91% to 66%.
A second CDC study found that a quarter of COVID-19 infections between May and July in Los Angeles were breakthrough cases, but hospitalizations were significantly lower for those who had been inoculated. Unvaccinated people were more than 29 times more likely to be hospitalized than vaccinated people, and about five times more likely to be infected.
Also in the news:
►Tennessee surpassed 1 million COVID-19 cases Tuesday amid a rise in hospitalizations and the rapid spread of the virus among the unvaccinated and school-age children. It’s the 12th state to hit the milestone, according to Johns Hopkins University data.
►Delta Air Lines plans to charge workers who refuse to get a COVID-19 vaccination an extra $200 per month for their health insurance.
►New York Gov. Kathy Hochul said requiring vaccination or weekly testing for K-12 teachers and staff and mandating masks inside schools will be among her first actions after being sworn in as governor Tuesday.
►More than 1,000 attendees at the Latitude Festival, a U.K. music festival, tested positive for COVID-19, the BBC reported.
►China warned residents in at least 12 cities they may face punishments for refusing a COVID-19 vaccine if they are later connected to an outbreak, the New York Times reported.
►Health officials are warning people to not use a drug called ivermectin, an animal dewormer, to treat or prevent COVID-19 after several hospitalizations.
📈Today’s numbers: The U.S. has recorded nearly 38 million confirmed COVID-19 cases and more than 630,000 deaths, according to Johns Hopkins University data. Global totals: More than 213 million cases and 4.45 million deaths. More than 171 million Americans – 51.6% of the population – have been fully vaccinated, according to the CDC.
📘What we’re reading: COVID-19 vaccines for young children: When are they coming? And what’s the status of clinical trials? Here’s what you need to know.
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About 89% of federal rental assistance approved by Congress remains unspent, despite President Joe Biden’s efforts to encourage states and cities to get the money out faster as a potential eviction crisis looms.
The Treasury Department on Wednesday released updated payout figures that show states and cities distributed $1.7 billion to landlords and renters in July, a modest increase from the $1.5 billion distributed in June.
All told, states and cities spent $5.2 billion out of $46.5 billion in rental relief authorized from COVID-19 rescue packages since December – $4.7 billion of which has gone directly to households and the rest toward administrative costs. About 11% of the total allotment of federal funds has now been dispersed.
One of six renters is estimated to be behind on their rent, according to the U.S. Census Bureau’s Household Pulse Survey. Yet in many states, landlords and renters have struggled to get approval for funds designed to help renters unable to make payments during the pandemic.
– Joey Garrison
For most of this year, the drugs President Donald Trump credited for his quick recovery from COVID-19 have sat unused on government shelves. But now, demand is skyrocketing.
Regeneron, the Tarrytown, New York, company which makes a monoclonal antibody, shipped more than 150,000 doses of REGN-COV2 natiowide this week. In mid-July, it sent out less than 25,000 doses a week.
Demand for sotrovimab, another monoclonal antibody authorized for use against COVID-19, has spiked almost 300% over the last month.
The extra push, said Dr. Howard Huang, who has led Houston Methodist Hospital’s monoclonal antibody effort, likely comes from the surge of COVID-19 cases, better public awareness of the drugs and doctors’ successful experiences with them earlier in the pandemic.
– Karen Weintraub
Shortly before noon Friday, Jacquelyn Graham-Townes leaned over a white casket containing another person who ended up in her care because of the coronavirus.
She echoed what doctors and nurses at local hospitals have been saying for weeks: What’s happening in Jacksonville now is worse than anything the city experienced in 2020.
Last year the mortuary handled funeral arrangements for about five COVID-19 deaths.
“I’ve done four in one day,” she said. “It’s like the floodgates broke open.”
Florida is awash in COVID-19 infections, and Duval County is struggling to keep its head above water. The 1,486 Floridians reported dead the week ending Friday is almost 15 percent higher than the previous worst week, in January. Hospitalizations as of Saturday were almost 70% higher than last winter’s peak.
It was all on display in Jacksonville. More than 70 people have died this month alone of COVID at trauma center UF Health Jacksonville. People have been lining up to receive the REGEN-COV antibody cocktail from the company Regeneron in efforts to prevent serious illness. At schools, parents, teachers and students worry about the potential for the virus’ spread. Read more here.
– Mark Woods, Nada Hassanein, Emily Bloch and David Bauerlein
Last year’s influenza season turned out to be the mildest on record, but health experts have renewed warnings that a ‘twindemic’ – in which flu and COVID-19 cases simultaneously rise and overwhelm hospitals – may be possible this year, and they urge Americans to get their flu shot.
Health experts say this year may resemble a more typical flu season, as students get back to in-person learning and states loosen mask and social distancing mandates amid a return to social gatherings. That is especially concerning as COVID-19 cases driven by the delta variant rise throughout the country.
“We were worried about the ‘twindemic’ last year and we face the same threat this year,” said Dr. Daniel Solomon, a physician in the division of infectious diseases at Brigham and Women’s Hospital. “COVID-19 is likely to continue, and we face the threat of dual respiratory viruses that could put a strain on our health care system.”
– Adrianna Rodriguez
The Food and Drug Administration’s full approval of the Pfizer-BioNTech COVID-19 vaccine launched a flood of vaccination mandates across the United States that will push millions of Americans to either get vaccinated or face serious consequences.
The range of people covered by vaccine requirements on the heels of Monday’s action now includes the U.S. military, New York City public school teachers and staffers, all New Jersey teachers and state employees, students at multiple university systems, corporate employees and pharmacists at CVS Health, and 30,000 unionized workers at Disney World.
Defense Secretary Lloyd Austin said in a memo Wednesday he was ordering service leaders to “impose ambitious timelines for implementation” of vaccine requirements.
That adds to millions of Americans for whom putting off COVID-19 vaccination could mean anything from having to get tested for the virus every week to losing their job or being barred from school.
The White House received a new classified intelligence report about the origins of the coronavirus on Tuesday, but it did not come to a solid conclusion as to whether the virus originated in animals before transferring to humans or was released from a lab, according to news reports.
Biden had asked the intelligence community in May to step up efforts to investigate COVID-19’s origins after officials could not agree on a conclusion. According to The Washington Post, intelligence officials will seek to release portions of the report publicly.
The Wall Street Journal reported that U.S. officials said part of the reason for inconclusiveness was a lack of information about China.
“It was a deep dive, but you can only go so deep as the situation allows,” a U.S. official told The Wall Street Journal. “If China’s not going to give access to certain data sets, you’re never really going to know.”
The World Health Organization and China concluded back in March that it was “extremely unlikely” the virus escaped from a lab, a theory that emerged from a series of sources with circumstantial evidence, including repeated assertions from former President Donald Trump and his allies, without citing specific evidence.
A handful of schools are charging unvaccinated students thousands of dollars in COVID-19 testing fees to remain on-campus this fall during the pandemic.
And some schools are imposing extra punishments: Quinnipiac University in Hamden, Connecticut, announced that along with fining unvaccinated students, it would cut off their campus Wi-Fi access.
Now, schools are starting to disenroll unvaccinated students.
Last week, the University of Virginia disenrolled 49 students who didn’t comply with the school’s vaccine mandate. Xavier University of Louisiana, a private Catholic HBCU in New Orleans, confirmed to USA TODAY that it had also started disenrolling unvaccinated students on Monday, the first day of classes.
Rowan University, a public school in Glassboro, New Jersey, announced Monday that with the full FDA approval of the Pfizer vaccine, students have until Sept. 7 to get their first shot. After that day, students who can’t prove vaccination or have valid declination form are at risk of having their “accounts put on hold, removal from residence halls (if applicable) and eventually, removal from the University.” Read more here.
— Lindsay Schnell
Contributing: Adrianna Rodriguez, USA TODAY; The Associated Press