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The U.S. Food and Drug Administration authorized Merck’s COVID-19 antiviral for adults who have tested positive for the virus and are at high risk of disease progression early Thursday, granting it a more limited use than the rival one from Pfizer that was authorized on Wednesday.
The Merck
MRK,
antirival called molnupiravir can only be prescribed for adults 18 and older and can only be given “when alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”
The regulator on Wednesday authorized Pfizer’s
PFE,
antiviral paxlovid for people who are at least 12 years old, have confirmed mild or moderate cases of COVID-19, and are at high risk for disease progression. That authorization did not include any prescription limitations relating to other treatments.
The news came amid a flurry of positive news on COVID treatments, with Novavax
NVAX,
saying late Wednesday that its booster showed immune responses against the highly transmissible omicron variant, which is fast becoming dominant in the U.S. and elsewhere.
While scientists are still working to learn more about omicron, early data show it is far more infectious than other variants and reduces the effectiveness of vaccines, but several studies suggest that it creates mostly mild symptoms and that far fewer patients require hospitalization than with other variants.
“We are encouraged that boosted responses against all variants were comparable to those associated with high vaccine efficacy in our Phase 3 clinical trials, suggesting that NVX-CoV2373 can play an important role in the ongoing fight against new variants,” said Gregory Glenn, Novavax’s president of research and development, in a statement.
Separately, AstraZeneca
AZN,
AZN,
said its COVID vaccine significantly increased levels of antibodies against the omicron variant as a third-dose booster shot in a study, as Dow Jones Newswires reported.
The news comes as omicron continues to push case loads higher across the U.S., putting them at levels last seen late in the summer. The nation is averaging 168,409 new cases a day, according to a New York Times tracker, which is close to where it was on Sept. 1 and up 38% from two weeks ago.
The U.S. is averaging more than 1,300 COVID deaths a day, the tracker shows. Caseloads are highest in the Northeast, and are up more than 80% in New York in the past two weeks.
For now, two vaccine doses plus a booster appear to offer the best protection against omicron infection, making it more important than ever that the unvaccinated get their shots.
President Joe Biden said earlier this week that the U.S. was in a “critical moment.”
“We also have more tools than we’ve ever had before. We’re ready. We’ll get through this,” Biden said, as he gave a speech at the White House and confirmed plans to distribute 500 million rapid at-home tests to Americans.
That will be too late for people planning to gather with family and friends over the holiday period, and experts are urging individuals to put safety over any other consideration.
See now: To detect omicron, take an rapid COVID-19 test right before a holiday gathering, experts say
Dr. Anthony Fauci, Biden’s chief medical adviser, said at a White House briefing on Wednesday that it’s not safe to attend large gatherings over the holidays, including for people with boosters.
“There are many of these parties that have 30, 40, 50 people in which you do not know the vaccination status of individuals. Those are the kind of functions in the context of omicron that you do not want to go to,” Fauci said at a White House briefing.
A day after Israel announced plans to offer fourth vaccine doses to vulnerable groups, the head of the World Health Organization said blanket booster programs in rich countries risk prolonging the world’s battle with COVID and said “no country can boost its way out of the pandemic.”
WHO Director General Tedros Adhanom Ghebreyesus said the priority must be to reduce deaths and help all countries meet minimum vaccination targets that many haven’t reached. And he noted that “the vast majority of hospitalizations and deaths are in unvaccinated people, not unboosted people, as the Associated Press reported.
The agency has long urged wealthier nations to do more to get primary shots to those parts of the world that remain largely unvaccinated as new variants are likeliest to emerge among such populations.
Elsewhere, China ordered the lockdown of as many as 13 million people in neighborhoods and workplaces in the northern city of Xi’an following a spike in coronavirus cases, setting off panic buying just weeks before the country hosts the Winter Olympics, the AP reported separately. State media reported that city officials had ordered all residents to stay home unless they had a pressing reason to go out and suspended all transport to and from the city apart from special cases.
Spain is mandating face masks outdoors again as omicron fuels a surge in cases. Prime Minister Pedro Sánchez also announced a raft of other measures, including an offer to deploy the armed forces to help Spain’s regions step up their vaccination rollout and put military hospital beds at their disposal if they are needed.
South Korea set a record for COVID deaths, and officials said omicron will soon be the dominant strain there, the AP reported. The Korea Disease Control and Prevention Agency said a record 109 people died in the latest 24-hour period, raising the country’s total number of pandemic fatalities to 5,015.
Australia has reintroduced some of its restrictions including face mask mandates indoors, capacity limits and Q4 code check-ins as cases set another one-day record, Reuters reported. The country recorded more than 8,200 new cases, by far its biggest daily rise since the pandemic began, from a previous record of 5,600, mostly in the states of New South Wales and Victoria.
Latest tallies
The global tally for the coronavirus-borne illness climbed above 277.3 million on Thursday, while the death toll edged above 5.38 million, according to data aggregated by Johns Hopkins University.
The U.S. continues to lead the world with 51.5 million cases and 812,283 deaths.
India is second by cases after the U.S. at 34.8 million and has suffered 478,759 deaths. Brazil has had the second highest death toll at 618,091 and 22.2 million cases.
In Europe, Russia has the most fatalities at 295,296, followed by the U.K. at 148,038.
China, where the virus was first discovered late in 2019, has had 113,299 confirmed cases and 4,809 deaths, according to its official numbers, which are widely held to be massively understated.
