Pfizer and German partner BioNTech have requested authorization for their COVID-19 vaccine booster shot for anyone 18 or over living in the U.S., a move that would greatly expand the program and boost protection levels.
filed for the authorization from the U.S. Food and Drug Administration mid-afternoon, after a report in the Washington Post that they would do so.
The report said the FDA is likely to support the application, which would effectively fulfill President Joe Biden’s goal expressed in the summer of getting boosters to all adults to address waning vaccine protection. The news comes exactly a year after Pfizer unveiled the vaccine and said it was effective at protecting against the virus.
The U.S. is still averaging about 1,200 deaths a day, according to a New York Times tracker, an undesirably high level almost two years into the pandemic. And, while cases are declining, they are still averaging more than 70,000 a day, and almost 50,000 people are being hospitalized a day.
Hot spots remain, too, including California and Colorado, and experts are worried that cases could surge again during the winter months when people are likely to gather in indoor settings.
Many states have mostly abandoned the public safety measures implemented last year, and there are still millions of eligible Americans who have opted not to get vaccinated. Experts lament that so many deaths are among that group, and that those people are dying what are preventable deaths.
The Centers for Disease Control and Prevention’s vaccine tracker is showing that 194 million Americans are fully vaccinated, equal to 58% of the overall population. That number has barely budged in weeks and is well below the 70% needed to stop the spread. Some 24.8 million people have had booster shots, which are outpacing primary doses on a daily basis.
A college in Colchester, Vt., is blaming Halloween parties for an outbreak of cases that have led the state to record numbers in the last week, according to a New York Times report. New daily cases have increased 51% in the past two weeks, according to the Times tracker, and hospitalizations are also climbing and raising concerns about the state’s hospital capacity as winter approaches.
The Biden administration framed its vaccine mandate for private employers in life-or-death terms Monday in a legal filing that sought to get the requirement back on track after it was halted by a federal circuit court, the Associated Press reported.
Its filing in response to a stay issued over the weekend by the New Orleans–based 5th U.S. Circuit Court of Appeals said there is no reason to rush into a ruling on whether the halt should be made permanent because the vaccine mandate won’t take effect until Jan. 4. Stopping the mandate from taking effect will only prolong the COVID-19 pandemic and would “cost dozens or even hundreds of lives per day,” lawyers for the Justice and Labor departments said.
The White House has been sued by more than two dozen Republican state attorneys general and others over its vaccine mandate for companies with more than 100 employees.
Travelers who meet certain requirements will be allowed to enter the U.S. beginning Nov. 8. WSJ’s Allison Pohle explains what these new rules mean. Photo: Joe Raedle/Getty Images
In other medical news, Moderna
is seeking an update to the conditional authorization of its COVID-19 vaccine in Europe so that it includes children between the ages of 6 and 11.
Moderna delayed filing for authorization in this age group in the U.S. until the Food and Drug Administration’s review of the myocarditis risk in teens is resolved, likely by January. Moderna’s clinical data show that its shot has an efficacy rate of 80% at preventing infection, including symptomatic and asymptomatic cases, among children in this age group two weeks after they received a second dose.
and its partner, privately held Ridgeback Biotherapeutics, said the U.S. government will exercise options to buy 1.4 million additional courses of the companies’ antiviral pill molnupiravir for $1 billion if the COVID-19 treatment is either granted emergency-use authorization or approved by the Food and Drug Administration.
That brings the total commitment from the U.S. government to 3.1 million courses of molnupiravir for $2.2 billion, between authorization and early 2022.
Beximco Pharmaceuticals Ltd. said Tuesday that it has launched the first generic version of molnupiravir in Bangladesh, Dow Jones Newswires reported.
Elsewhere, Singapore will no longer cover the medical bills of people who are “unvaccinated by choice” after Dec. 8, according to the Ministry of Health.
“Currently, unvaccinated persons make up a sizeable majority of those who require intensive inpatient care, and disproportionately contribute to the strain on our healthcare resources,” the ministry said in a statement.
In China, the city of Heihe is offering thousands of dollars for anyone giving clues in tracing the source of its latest outbreak, as part of a “people’s war” to stamp out one of the country’s largest resurgences in months, AFP reported. China reported 43 local cases on Tuesday in a delta-variant-driven surge that has fanned out to 20 provinces and regions, keeping new case numbers in the double digits over the past three weeks.
Russia said the decision to close down workplaces for a week has helped turn the tide on its wave of COVID cases, the Guardian reported. The health minister told a televised government meeting on Tuesday that the increase in the number of patients receiving medical care had slowed last week for the first time since the beginning of August, though he said it remained “quite high.”
However, the country reported a record one-day death toll of 1,211 on Sunday.
The global tally for the coronavirus-borne illness climbed above 250.6 million on Tuesday, while the death toll edged above 5.06 million, according to data aggregated by Johns Hopkins University.
The U.S. continues to lead the world with a total of 46.6 million cases and 755,988 deaths.
India is second by cases after the U.S. at 34.4 million and has suffered 461,389 deaths. Brazil has the second highest death toll at 609,573 and 21.9 million cases.
In Europe, Russia has recorded the most fatalities at 244,588, followed by the U.K. at 142,555.
China, where the virus was first discovered late in 2019, has had 110,331 confirmed cases and 4,809 deaths, according to its official numbers, which are widely held to be massively understated.