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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

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 (NYS:MRK) 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 (NYS:PFE) 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%. 

Read now: ‘Don’t freak out’: Omicron is bound to disrupt supply chains. The question is, how bad will it be?

The WHO’s 194 member countries agreed unanimously to adopt a resolution to develop a new accord for handling future pandemics, AFP reported. The agreement came at a special meeting in Geneva.

“The adoption of this decision is cause for celebration and cause for hope that we all need,” WHO chief Tedros Adhanom Ghebreyesus said in closing the three-day gathering.

The U.S. is still averaging almost 900 deaths a day from COVID, according to a New York Times tracker, and cases and hospitalizations are undesirably high. Michigan continues to lead other states by new cases measured on a per capita basis. It’s averaging more than 8,000 cases a day.

The CDC’s vaccine tracker, meanwhile, is showing that 197 million people living in the U.S. are fully vaccinated, equal to 59.4% of the overall population. That number is crawling higher after being static for weeks.

See: Confused about whether to get a COVID booster? Here’s what to know.

Elsewhere, the head of the European Commission, Ursula von der Leyen, said Wednesday that the EU must consider mandatory vaccination because of the omicron variant, the Guardian reported. Von der Leyen said the EU’s 27 member states should rapidly deploy booster doses and a commission communiqué backed countries that are temporarily enforcing pre-travel PCR tests even within the bloc’s borders.

The EU will roll out Pfizer and BioNTech’s (NAS:BNTX) COVID-19 vaccine version for 5- to 11-year-old children on Dec. 13, one week earlier than previously planned, Germany’s health ministry said on Wednesday, as Reuters reported.

Marcus Lamb, head of U.S. Christian television network Daystar, who railed against COVID vaccines, has died after contracting the illness, the Washington Post reported. The 64-year-old Lamb’s network made the virus a huge focus during the pandemic, calling it a satanic attack that should not be treated with vaccines.

Saudi Arabia became the first country in the Persian Gulf to detect a case of omicron, Al Jazeera reported. The case was in a Saudi national who had traveled home from a North African country.

Japan’s main airlines halted new reservations from overseas on Wednesday until the end of December after detecting a second omicron case, reported Reuters. The move came at the request of the transport ministry, which has also requested foreign airlines to halt all such reservations.

Don’t miss:   ‘Vaccine’ chosen as word of the year by Merriam-Webster

Latest tallies

The global tally for the coronavirus-borne illness climbed above 263 million on Tuesday, while the death toll edged above 5.21 million, according to  data aggregated by Johns Hopkins University .

The U.S. continues to lead the world with a total of 48.6 million cases and 780,244 deaths. 

India is second by cases after the U.S. at 34.6 million and has suffered 469,247 deaths. Brazil has the second highest death toll at 614,681 and 22.1 million cases.

In Europe, Russia has reported the most fatalities at 271,091, followed by the U.K. at 145,414.

China,  where the virus was first discovered late in 2019,  has had 111,353 confirmed cases and 4,809 deaths, according to its official numbers, which are widely held to be massively understated.

Link to MarketWatch's Slice.