Axios

An FDA advisory panel on Tuesday voted 13-10 to endorse an antiviral pill developed by Merck and Ridgeback Biotherapeutics to treat adults at high risk of becoming severely ill from COVID-19, despite concerns over its effectiveness and safety.

Why it matters: Oral antiviral drugs designed to prevent or treat COVID-19 could be key pandemic-fighting tools, if proven effective, especially as new variants emerge. If authorized, the Merck drug, known as molnupiravir, would be the first treatment of its kind to be made available in the U.S.

The World Health Organization on Tuesday advised those 60 or older and other vulnerable people to postpone travel plans in response to the emergence of the COVID-19 Omicron variant.

Driving the news: The WHO said on Monday that the Omicron variant poses a "very high" risk and may be more transmissible than other strains of COVID-19.

Dutch health officials announced Tuesday that they have discovered two cases of the new Omicron variant in the country dating back to Nov. 19 and Nov. 23, days before the variant's detection was announced by South African scientists.

Why it matters: Although the Netherlands announced that it had discovered more than 10 Omicron cases last Sunday, the discovery of these new, older cases means the variant was already spreading in Western Europe before Omicron's existence was publicly known.

New York City will authorize two supervised injection sites to begin operating as soon as Tuesday as part of an effort to prevent drug overdose deaths, which are at record levels in the city and across the U.S., Mayor Bill de Blasio announced.

Why it matters: New York is now the first U.S. city to start operating overdose prevention centers, trained staff at which will provide clean needles, reverse overdoses with naloxone and help people find addiction treatment services, according to the New York Times.

Moderna's stock soared 12% Monday, putting its market cap just shy of $150 billion.

Driving the news: The Omicron variant of the coronavirus has raised a lot of questions, including whether the vaccines will remain as effective.

The emergence of the Omicron COVID variant is turbocharging the push for vaccine boosters, and experts say a booster may soon become a requirement to be considered "fully vaccinated."

Why it matters: Booster uptake has been sluggish so far, and adding a third shot to vaccine mandates would be highly controversial.

New York City officials issued an advisory Monday "strongly" recommending that people mask up indoors regardless of vaccination status to curb the spread of the newly-discovered Omicron variant.

Why it matters: Dave Chokshi, commissioner of the New York City Department of Health and Mental Hygiene, announced the advisory in response to concerns of the new strain's potential implications.

A federal court in Missouri has blocked the Biden administration from enforcing a coronavirus vaccine mandate for health care workers at federally funded facilities in 10 states.

Why it matters: Monday's decision is the first victory for opponents of the rule, which requires health care workers to get vaccinated by Jan. 4, 2022. The case is one of four lawsuits challenging the Centers for Medicare & Medicaid Services' (CMS) rule and argues that the mandate will exacerbate staffing shortages.

The Centers for Disease Control and Prevention (CDC) on Monday strengthened its previous recommendation for booster shots, saying that everyone 18 and older "should" receive a booster dose.

Why it matters: Last month, CDC director Rochelle Walensky accepted a key advisory committee's recommendation that adults "may" get the shot. The slight, but strengthened, change in wording comes amid the emergence of the Omicron coronavirus variant.

President Biden on Monday said that the new coronavirus variant, Omicron, is "a cause for concern, not a cause for panic."

Driving the news: Biden said later this week the administration will be releasing a strategy on how "we're going to fight COVID this winter. Not with shutdowns or lockdowns, but with more widespread vaccinations, boosters, testing and more."

The Transportation Security Administration screened 2,451,300 people at airports across the U.S. on Sunday, making it the busiest day for air travel since the beginning of the pandemic.

Driving the news: Nearly 20.9 million passengers passed through TSA checkpoints from Nov. 19 through Nov. 28, more than double the number of air travelers screened during the same period last year, TSA said.

The World Health Organization said Monday in a new risk assessment that it believes the COVID-19 Omicron variant poses a "very high" risk to the globe because it may be more transmissible than other strains of the virus.

Why it matters: Though the WHO acknowledged there are still many uncertainties associated with the variant, the agency said it believes the likelihood of potential further spread of Omicron around the world is "high."

An Ohio man appears to have been cured of his Type 1 diabetes after participating in an early-stage clinical trial of a stem cell treatment by Vertex Pharmaceuticals, the New York Times reports.

Why it matters: If ultimately successful, the development could offer hope to millions of Americans who suffer the life-altering symptoms of the disease.

Box office ticket sales over the Thanksgiving holiday show that consumer confidence in moviegoing is slowly improving but not enough to bring the struggling theater industry back to pre-pandemic levels anytime soon, if ever.

Why it matters: "We may have to temper expectations a bit" for next year, said Comscore senior media analyst Paul Dergarabedian.

The emergence of the Omicron variant is bringing new urgency to global vaccination efforts.

Why it matters: New variants can emerge anywhere, and can spread everywhere. Getting doses to the developing world — and getting those doses into people's arms — is essential, and that effort has so far been lagging.

A bipartisan group of U.S. House members chided the Biden administration for repealing a rule that would have required Medicare to pay for any medical device deemed a "breakthrough" by the FDA.

The big picture: Medical device manufacturers really wanted the rule enacted, in part, because it would have led to higher sales. Now many members of Congress who receive sizable campaign donations from the industry want the federal government to revive the rule.

The first two cases of the new Omicron variant have been detected in North America, the Canadian government announced Sunday evening.

Driving the news: The World Health Organization has named Omicron a "variant of concern," but cautioned earlier on Sunday that it is not yet clear whether it's more transmissible than other strains of COVID-19.

The World Health Organization called on countries Sunday not to impose travel bans on southern African nations amid concerns over the COVID-19 Omicron variant.

Why it matters: The U.S. and countries in Europe and the Asia-Pacific announced travel restrictions in response to Omicron, which was first detected in South Africa. It's since been identified in several European countries, Canada, Israel, Australia and Hong Kong. The WHO noted in a statement that only two southern African nations have detected the new strain.