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Dec. 2, 2021, 7:52 a.m. EST

U.S. to tighten testing requirements for travelers in light of omicron variant, and analysts expected limited authorization of Merck antiviral

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By Ciara Linnane

The U.S. is planning to beef up testing requirements for international travelers entering the country in the light of the new omicron variant of the coronavirus that causes COVID-19, including shortening the time a test must be taken prior to travel.

The move comes as the Centers for Disease Control and Prevention confirmed that a first case of omicron has been detected in the U.S. The individual was a traveler who returned from a visit to South Africa on Nov .22 and tested positive on Nov. 29. Omicron was first reported by scientists in South Africa and was declared a “variant of concern” by the World Health Organization last Friday.

 Dr. Anthony Fauci, President Joe Biden’s top medical adviser, announced the news during a briefing on Wednesday for reporters.

“The individual is self quarantining, and all close contacts have been contacted and all close contacts thus far have tested negative,” Fauci said. “The individual was fully vaccinated and experienced mild symptoms, which are improving at this point. So this is the first confirmed case of COVID-19 caused by the omicron variant detected in the United States.”

The precise new travel protocols are still being finalized ahead of a speech by President Joe Biden planned for Thursday on the country’s plan to control the COVID-19 pandemic during the winter season, the Associated Press reported, citing a senior administration official who said some details could still change.

Among the policies being considered is a requirement that all air travelers to the U.S. be tested for COVID-19 within a day of boarding their flight, compared with the current regimen that allows for a test to be taken within three days of boarding.

“CDC is evaluating how to make international travel as safe as possible, including pre-departure testing closer to the time of flight and considerations around additional post-arrival testing and self-quarantines,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Tuesday.

Other possibilities include requiring testing after arrival and even forcing people to quarantine. The U.S. reopened its border to fully vaccinated travelers on Nov. 8.

For now, further testing is required to determine whether omicron is more transmissible, more lethal or resistant to current vaccines and treatments.

The WHO is urging leaders to step up surveillance and sequencing, and encouraging people to get their vaccine shots and stick with mitigation measures like wearing a face mask in public, socially distancing and washing hands frequently.

The strain has been found in more than 20 countries, and many have moved to restrict or outright ban travel from South Africa and neighboring countries. Dr. Anthony Fauci, the top U.S. government infectious-disease expert, said more would be known about omicron in two to four weeks as scientists grow and test lab samples of the virus.

In other medical news, a U.S. Food and Drug Administration advisory panel ended a meeting Tuesday by narrowly voting to recommend Merck’s COVID-19 pill  for adults at high risk of hospitalization and death. The panel voted 13-10 in favor of authorizing the treatment, called molnupiravir.

But analysts said they now expect nothing more than a “tepid” authorization from the FDA, which is not obliged to follow the panel’s recommendations, although it often does, after doctors raised questions about the drug’s efficacy and safety profile, particularly among people who are pregnant, as MarketWatch’s Jaimy Lee reported.

“The near split vote reflects concerns over molnupiravir’s modest clinical efficacy, with results in the post-interim period contrasting with the more positive interim results that led to early study stoppage,” SVB Leerink analysts told investors on Wednesday. “We expect these concerns to follow the therapy and limit uptake particularly when alternative therapies become available.”

Merck /zigman2/quotes/209956077/composite MRK -0.50% first shared interim data back in October showing molnupiravir can reduce the risk of hospitalization and death by 50%. The news brought widespread exhilaration.  Markets soared , and physicians applauded the arrival of a  promising new tool  for curbing the pandemic. 

But then two things happened: Pfizer /zigman2/quotes/202877789/composite PFE -0.37% shared interim data in November for its own COVID-19 pill that showed Paxlovid reduced the risk of hospitalization and death by a  remarkable 89% , and then Merck released full data the day after Thanksgiving that demonstrated its drug doesn’t work as well as we thought — it can reduce hospitalization and death by 30%, not 50%. 

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