YCLOAK

New Zealand will adopt what is being called a “traffic light” system to curb the spread of COVID-19 and limit the use of lockdowns.

New Zealand’s planned traffic light system has red, amber and green categories, and gives more freedoms to the fully vaccinated. The biggest city, Auckland, is a red zone, mainly because of its high number of COVID-19 cases. Residents there are allowed into cafes, gyms and hairdressers, but there are limits on capacity and proof of vaccination is mandatory.

Much of the country is under the less stringent amber traffic light. The settings will be reviewed in two weeks.

Michael Baker, a public health and epidemiology professor at the University of Otago in Wellington, said the new system is designed to boost vaccination rates.

“There is a band across the central North Island of districts with relatively low vaccine coverage,” he said. “They are automatically going into the red-light classification. This system has two main purposes. One is really to limit transmission of the virus, so it means that if you are indoors, you are indoors with other vaccinated people. But the other thing it does it is sending a very strong message to the unvaccinated, a very strong nudge — you need to get vaccinated. So, I think it will be effective at doing that.”

New Zealand’s Health Ministry estimates that about 86% of the eligible population has received two vaccine doses.

New Zealand has had some of the world’s toughest pandemic controls.

The country’s international borders are expected to remain closed to most foreign nationals until well into next year.

Prime Minister Jacinda Ardern said the omicron variant is a reminder of why New Zealand needs to maintain its “careful approach” to the virus.

With 5 million people, the South Pacific country has recorded 12,000 coronavirus cases and 44 deaths since the pandemic began.

The traffic light system replaces previous coronavirus alert levels. A recent delta variant outbreak forced New Zealand government to abandon its COVID-zero strategy in favor of a strategy that prioritizes containment. The previous approach was designed to eliminate the virus in New Zealand through border closures and strict lockdowns. 

 

 
…

Multiple cases of the omicron coronavirus variant have been detected in New York, health officials said Thursday, including a man who attended an anime convention in Manhattan in late November and tested positive for the variant when he returned home to Minnesota.

In addition to the conventioneer, tests showed five other people recently infected with COVID-19 had the variant, health officials said. They included a person in the city’s Long Island suburbs who had recently traveled to South Africa, residents of Brooklyn and Queens, and another case possibly linked to travel.

“No cause for alarm. We just want to make sure that the public is aware of information when we receive it,” said Governor Kathy Hochul.

New York City Mayor Bill de Blasio said the geographic spread of the positive tests suggested the variant was undergoing “community spread” in the city and wasn’t linked to any one event.

The news came a day after the U.S. announced its first case of the variant had been detected in California, in a person who had recently traveled to South Africa.

Officials reported another case Thursday in a Colorado woman who had recently traveled to southern Africa.

The Anime NYC 2021 convention Nov. 19-21 drew about 50,000 people, according to event organizers, and attendees were required to wear masks and show proof of having received at least one dose of a COVID-19 vaccine.

Officials in New York said they were working to trace attendees of the convention, which was held at the Jacob K. Javits Convention Center as New York City prepared to host the annual Macy’s Thanksgiving Day Parade and braced for throngs of tourists to return after the U.S. opened up to vaccinated international travelers.

Infections were expected

Officials in the city of 8.8 million said they expected it would be only a matter of time before the new variant was reported in the city. City Health Commissioner Dave Chokshi urged people who attended the event to get tested.

“We should assume there is community spread of the variant in our city,” de Blasio said in a statement.

The Minnesota man began experiencing mild symptoms Nov. 22. He had been vaccinated and received a booster shot in early November, according to health officials in his home state. He sought COVID-19 testing Nov. 24, and his symptoms have subsided, officials said.

Minnesota Health Commissioner Jan Malcolm said the man had not traveled outside the U.S. recently.

“Just given the timing … it seems quite possible, perhaps the most likely, that this transmission happened at the arena convention in New York City, but that’s not definitive,” Malcolm said.

Nov. 22 was the same day the person infected in the California case returned to the U.S. from South Africa. The California traveler, who was vaccinated, developed mild symptoms and tested positive Monday.

Much remains unknown about the new variant, including whether it is more contagious, as some health authorities suspect, whether it makes people more seriously ill, and whether it can thwart the vaccine.

Omicron is classified by the World Health Organization as a “variant of concern” as scientists work to determine how it may compare with the predominant delta variant in terms of transmissibility and severity. Scientists also are studying the degree to which existing vaccines and therapies protect against omicron.

Scientists in South Africa first reported it, but the samples came from several countries in southern Africa. And health officials in the Netherlands now say it was found there prior to the South Africa detection.

‘Get vaccinated’

As comfort over air travel returns, it’s inevitable that new variants like omicron will spread from country to country and state to state, said professor Danielle Ompad, an epidemiologist at New York University’s School of Global Public Health.

“We shouldn’t panic, but we should be concerned,” she said.

Hochul said the case involving the Minnesota visitor underlined the need for everyone who is eligible to get vaccinated against COVID-19 or receive a booster shot if they have not already.

“There is one way to address this — New Yorkers, get vaccinated, get boosted, and get ready,” the Democrat said.

Japan’s consul general in New York, Kanji Yamanouchi, delivered the opening remarks at the convention.

A spokesperson for the consulate said Yamanouchi was vaccinated and received a booster shot about three weeks ago. He said staffers at the consulate underwent testing as a precaution.

“He had absolutely no problem in his health condition,” said the consulate’s spokesperson, Kenju Murakami, noting Thursday it had been nearly two weeks.

A website for the convention says that Anime NYC is mounted by Leftfield Media, an event company based in Shelton, Connecticut. A company spokesperson did not immediately respond to an email requesting comment.

Peter Tatara, its founder and event director, referred questions to company spokespeople. He said he had been tested “multiple times” since the event.

New York City Council Ben Kallos, who appeared at the event with the Japanese ambassador, said a rapid antigen test taken Thursday showed he was negative for the virus.

“I can attest to the fact that my vaccine was checked and I got a wristband, and the person who tested positive for omicron was also fully vaccinated,” Kallos said, urging his “fellow anime fans” to get tested. “So it goes to show you, even when you follow all the precautions, we’re still seeing breakthrough cases.” 
…

Omicron is unlikely to have completely outsmarted the vaccines, experts say, even with its unusual array of mutations. 

There are a lot of unknowns, but they expect that the shots will still do what they do best: Keep people out of the hospital and out of the grave.

Omicron raised alarms when it was first identified during a sharp spike in cases in South Africa. The World Health Organization added it to its list of variants of concern last week.

The virus contains dozens of mutations, including several that are thought to make it more infectious and others that appear to help it evade the immune system.

“But I think it’s still very possible that vaccines will hold up against severe disease, even with those mutations,” said Dr. Carlos del Rio, a professor of medicine at Emory University and president-elect of the Infectious Diseases Society of America.

That’s what has happened with every variant so far. With delta, he noted, “breakthrough” infections among vaccinated people have increased, but those cases are mostly mild.

Omicron seems to be better able than other variants to infect people who have already had COVID-19, according to early data from South Africa. But people with reinfections generally have not been seriously ill.

Experts are recommending boosters for people who can get them. U.S. officials have authorized them for everyone age 18 and older. 

Open questions 

Researchers will have more questions than answers about omicron for the next few weeks while they study the variant. They don’t yet know for sure how the virus stacks up against other variants in terms of how easily it infects or how sick it makes its victims.

Hospitalizations have increased in South Africa during the omicron surge, but it’s not clear if that’s because the virus causes more severe infections or because more people are getting infected. Most of the country is not vaccinated. 

Scientists need to figure out whether the rise in infections is “vaccine failure or failure to vaccinate,” said Dr. Walter Orenstein, associate director of the Emory University Vaccine Center.

“If it’s vaccine failure, is it a problem of time since the last dose and waning immunity?” Orenstein said. 

Though it does not yet seem to be necessary, some companies are working on modifying their vaccines to better protect against the new variant.

Moderna and the Pfizer-BioNTech partners say they can have a new vaccine ready in about three months. Johnson & Johnson says it is working on a new version but did not give a timeline. Oxford University told Reuters news agency that the vaccine it produces with AstraZeneca is still highly effective but that it can quickly update it if necessary. 

Many companies have started developing modified vaccines against previous variants, but none has gone to regulators for approval.

The U.S. Food and Drug Administration says it will not require drugmakers seeking approval for their updated vaccines to go through a process as lengthy as the one for the original versions. Much like with the annual flu vaccine, a few tests for safety and immune response will do. 

 
…

Two astronauts with the U.S. space agency, NASA, left the International Space Station (ISS) Thursday to conduct a spacewalk to replace a broken antenna system, two days after the walk was postponed over concerns about space debris.

NASA astronauts Thomas Marshburn and Kayla Barron stepped out of the ISS airlock early Thursday to replace the faulty antenna, used to communicate voice and data to ground control. The operation was expected to last six-and-a-half hours.

The spacewalk had originally been scheduled for Tuesday but was postponed late Monday after NASA said it had received a notification of space debris that it needed to assess. The space agency said once it determined the debris did not pose a risk, the operation was rescheduled for Thursday.

It was not immediately clear whether the debris field that prompted the spacewalk to be postponed was related to a Russian anti-satellite missile test two weeks ago. That event created a debris field that forced ISS crew members to seek shelter in their escape capsules as a precaution.

Some information for this report came from The Associated Press and Reuters. 
…

U.S. Vice President Kamala Harris on Wednesday criticized an “irresponsible” Russian test that endangered the International Space Station with debris, and the Biden administration laid out a new strategy for responsible use of space. 

Harris convened the inaugural meeting of the National Space Council and asked members of the government body to promote responsible civil, commercial and national security-related behavior in space, where there are growing commercial interests and concerns about Chinese and Russian competition. 

“Without clear norms for the responsible use of space we stand the real risk of threats to our national and global security,” Harris said. 

She said Russia’s “irresponsible act” of testing anti-satellite technology last month created debris that endangered the International Space Station (ISS). 

U.S. officials have fretted over rising security activity by Washington’s major rivals in space. China’s test of hypersonic weapons this year raised the prospect of an arms race over Earth-orbiting systems that could dodge current missile defenses. 

Meanwhile, a growing number of companies, including SpaceX, Blue Origin and Virgin Galactic, are seeking to usher in a new era of private commercial space flights following years of private firms working alongside the U.S. government’s National Aeronautics and Space Administration (NASA) in rocket launches. 

President Joe Biden also signed an executive order on Wednesday adding the heads of the Education, Labor, Agriculture and Interior Departments as well as his national climate adviser to the National Space Council. 

The administration also wants the group’s work to increase space climate data and enhance scientific-related efforts that could aid job creation and U.S. competitiveness, it said in a statement. 

The National Space Council is separate from the U.S. Space Force military branch created under former President Donald Trump. 
…

Marking the 33rd annual World AIDS Day on Wednesday, the Biden administration announced it would ramp up its domestic and international efforts to fight the HIV virus, which has killed 36 million people worldwide in four decades.

President Joe Biden also released Wednesday the domestic-focused National HIV-AIDS Strategy, which aims for a 90% reduction in new HIV cases in the U.S. over the next nine years. Currently, about 1.2 million Americans are thought to be living with the virus. The epidemic peaked in the U.S. in the 1980s.

The administration has said that racism that leads to unequal medical care is itself “a public health threat” that needs to be acknowledged in the battle against the virus. 

The president offered two new measures aimed at ending the epidemic in the United States by 2030 and boosting U.S. efforts to end the spread of HIV, the virus that can progress to AIDS, around the world.

“Today, we once more raise a two-story-tall red ribbon from the North Portico of the White House to remember how far we have come,” Biden told an audience of American activists, politicians and medical experts, including AIDS research pioneer Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “And the work we have left to finish, so we never forget the prices paid all along the way.” 

Internationally, where the bulk of new infections occur, the U.S. seeks to increase donor funding. On Wednesday, Biden said the U.S. would host the Global Fund to Fight AIDS replenishment conference next year. The U.S. is the fund’s largest donor, contributing about $17 billion to it last year. That’s in addition to a commitment Biden made earlier this year in which he sent $250 million of American Rescue Plan funding to the President’s Emergency Plan for AIDS Relief (PEPFAR), a program established in 2003 by President George W. Bush to combat the disease internationally.

Slow, unequal response 

Still, it’s not clear whether even that infusion of funds will right the ship. The United Nations’ AIDS organization said Wednesday that the global goal to end the epidemic by 2030 has been derailed — and not just by the coronavirus pandemic that upended global health policy and practices.

“Even before the COVID-19 pandemic hit, many of the populations most at risk were not being reached with HIV testing, prevention and care services,” said Tedros Adhanom Ghebreyesus, director-general of the World Health Organization. “The pandemic has made things worse, with the disruption of essential health services and the increased vulnerability of people with HIV to COVID-19. Like COVID-19, we have all the tools to end the AIDS epidemic, if we use them well. This World AIDS Day, we renew our call on all countries to use every tool in the toolbox to narrow inequalities, prevent HIV infections, save lives and end the AIDS epidemic.” 

Tedros has warned that discrimination and inequality are at the root of the epidemic, and that inattention to these problems would lead to 7.7 million AIDS-related deaths in the next 10 years. 

Other critics have knocked Biden for not moving fast enough on his promises to fight HIV. In August, the world’s premier medical journal, The Lancet, published a critique of Biden’s pace in nominating a new leader for PEPFAR. Biden announced his pick for the job, Cameroon-born John Nkengasong, a U.S. citizen who heads the Africa Centers for Disease Control and Prevention, in late September. The Senate received the nomination in mid-October and referred it to the Committee on Foreign Relations, where it remains.

“During his candidacy, U.S. President Joe Biden committed to prioritizing the global AIDS response,” the authors — two American and two African activists — wrote in the medical publication. “This promise has been contradicted by a 6-month delay in nominating an ambassador-at-large to lead PEPFAR, which has functioned without a presidentially appointed health diplomat since Ambassador Deborah L. Birx was detailed to the White House Coronavirus Task Force in February 2020.”

On Wednesday, as he recognized Nkengasong among the crowd gathered at the White House, Biden was hopeful.

“We can do this,” he said. “We can eliminate HIV transmission. We can get the epidemic under control in the United States and in countries around the world. We have a scientific understanding. We have treatments. We have the tools we need. We’re going to engage with people with lived experience with HIV and ensure that our efforts are appropriate and effective and centered around the needs of the HIV community.”
…

The Biden administration in its new HIV/AIDS strategy calls racism “a public health threat” that must be fully recognized as the world looks to end the epidemic.

The strategy released Wednesday on the annual commemoration of World AIDS Day is meant to serve as a framework for how the administration intends to shape its policies, research, programs and planning over the next three years.

The new strategy asserts that over generations “structural inequities have resulted in racial and ethnic health disparities that are severe, far-reaching, and unacceptable.”

New HIV infections in the U.S. fell about 8% from 2015 to 2019, but Black and Latino communities — particularly gay and bisexual men within those groups — continue to be disproportionately affected, according to Centers for Disease Control and Prevention data.

African Americans make up about 13% of the U.S. population but accounted for more than 40% of new infections. The Latino population accounted for nearly 25% of new infections but makes up about 18.5% of the U.S. population.

Historically, gay and bisexual men have been the most disproportionately affected group. They account for about 66% of new HIV infections, even though they account for only 2% of the population, according to the CDC. In 2019, 26% of new HIV infections were among Black gay and bisexual men, 23% among Latino gay and bisexual men, and 45% among gay and bisexual men under the age of 35.

To reduce the disparities, the strategy includes calls for focusing on the needs of disproportionately affected populations, supporting racial justice, combating HIV-related stigma and discrimination and providing leadership and employment opportunities for people with or at risk for HIV.

Besides addressing racism’s impact on Americans battling the virus or at risk of contracting it, the new strategy also puts greater emphasis on harm reduction and syringe service programs, encourages reform of state laws that criminalize behavior of people with HIV for potentially exposing others and adds focus on the needs of the growing population of people with HIV who are aging.

More than 36 million people worldwide, including 700,000 in the U.S., have died from AIDS-related illnesses since the start of the epidemic more than 40 years ago. Nearly 38 million people are living with HIV, including 1.2 million in the U.S.

President Joe Biden’s administration recently announced it will host the Global Fund to Fight AIDS replenishment conference next year. The United States has contributed about $17 billion to the fund, about a third of all donor contributions.

A giant red ribbon, a symbol of support for people living with HIV, was also displayed on the North Portico of the White House to mark World AIDS day. The two-story ribbon display has become an annual tradition at the White House since 2007.

“Honored to continue this tradition on #WorldAidsDay, remembering the lives lost to HIV/AIDS and supporting those living with the virus across the world,” first lady Jill Biden said in a Twitter posting that included a photo of her posing in front of the ribbon display. 
…

European Union leaders said Wednesday they are considering a number of public health options, including vaccine mandates, to address the growing threat posed by the omicron variant of the virus that causes COVID-19. 

Speaking to reporters in Brussels, European Commission President Ursula von der Leyen said little is currently known about the variant, but enough is known to be concerned. She said they expect scientists to have a handle on the nature of the variant in about two to three weeks, but in the meantime are hoping for the best and preparing for the worst. 

Von der Leyen said the best use of that time is to get more people vaccinated, and those who are inoculated should get booster shots. She said more than one-third of the European population — 150 million people — are not vaccinated.

The European Commission president said that while not everyone can be vaccinated, the majority of people can.

“This needs discussion. This needs a common approach, but it is a discussion that I think has to be had,” she said. 

Von der Leyen said Pfizer-BioNTech has indicated it can accelerate the production and distribution of its children’s vaccine, which will be available to European children beginning December 13.

She also said Pfizer and Moderna are set to deliver 360 million more doses of their vaccines by the end of March 2022, and that boosters are available to those who received their initial shots. 

The commission also urged EU members to commit to a day-by-day review of travel restrictions and a readiness to impose all necessary controls, including decisive action, if clusters of the omicron variant are found. 

Some information for this report was provided by The Associated Press, Reuters, and Agence France-Presse. 

 
…

The World Health Organization (WHO) Wednesday began a lengthy process to develop an international agreement on the prevention and control of future pandemics.

The WHO’s World Health Assembly – the organization’s decision-making body – approved the effort at the end of a rare, three-day special session at the organization’s headquarters in Geneva. The plan, entitled “The World Together,” was created as the world is facing the new omicron variant of coronavirus. 

WHO Director-General Tedros Adhanom Ghebreyesus praised the decision, saying the pandemic has exposed shortcomings in the application and implementation of international health regulations established by the WHO in 2005.

The agreement would establish international standards on issues ranging from data sharing and genome sequencing of emerging viruses to equitable distribution of vaccine and drugs. 

Wednesday’s decision begins the process of drafting and negotiating the agreement, which is not expected to be completed until May 2024.

The European Union (EU) had pushed for the agreement on an international legally binding treaty, along with about 70 countries, but Brazil, India and the United States were among those reluctant to commit to a treaty, diplomats said. 

More than 262.22 million people have been reported infected with SARS-CoV-2, the virus responsible for COVID-19, and 5.46 million people have died of it since it emerged in China in December 2019. 

 

Some information for this report was provided by The Associated Press and Reuters. 
…

Nigeria has detected its first case of the omicron coronavirus variant in a sample it collected in October, weeks before South Africa alerted the world about the variant last week, the country’s national public health institute said Wednesday.

It is the first West African country that has recorded the omicron variant since scientists in southern Africa detected and reported it and adds to a list of nearly 20 countries where the variant has been recorded, triggering travel bans across the world. 

Genomic sequencing of positive cases of COVID-19 in Nigeria identified two cases of the omicron variant among travelers from South Africa, the Nigeria Center for Disease Control said in a statement issued by its director-general.

The two unidentified travelers arrived in the West African country last week, but the variant has also been confirmed in cases in Nigeria prior to their arrival.

“Retrospective sequencing of the previously confirmed cases among travelers to Nigeria also identified the omicron variant among the sample collected in October 2021,” Nigeria CDC director-general Dr. Ifedayo Adetifa said.

Much remains unknown about the new variant, including whether it is more contagious, as some health authorities suspect, whether it makes people more seriously ill, and if it can thwart the vaccine.

The Nigeria CDC urged the country’s states and the general public to be on alert and called for improved testing amid concerns that Nigeria’s low testing capacity might become its biggest challenge in the face of the new variant.

Testing for the virus is low in many states and even in the nation’s capital, Abuja. For instance, in parts of Kuje, a suburb of Abuja, Musa Ahmed, a public health official, told The Associated Press that no one has been tested for the virus for weeks.

The detection of the omicron variant in Africa’s most populous nation, with 206 million people, coincides with Nigeria’s new requirement that all federal government employees must be inoculated or present a negative COVID-19 test result done in the last 72 hours. 

With the vaccine mandate taking effect on Wednesday, there were chaotic scenes at several offices in the nation’s capital as civil servants without a vaccination card or a negative PCR test were turned away by security agents.

Many of the workers and security agents were not wearing face masks.

“Governments should invest in promoting narratives around vaccine safety, efficacy, and the broader public health security implications of poor vaccines uptake,” Adewunmi Emoruwa, lead strategist at Gatefield, an Abuja-based consultancy. “If public servants are convinced about these issues, they are naturally more effective advocates to their constituents.”

Across Nigeria, the news of the omicron variant — which the World Health Organization has warned poses “very high” risk — has triggered concerns and renewed fears over the COVID-19 pandemic.

At the airport in Lagos, Nigeria’s largest city and economic hub, authorities insisted that travelers must wear their face masks at the counters, though not much attention is paid to many others flouting health protocols around the airport premises and in the city. 

Nigeria — with 214,218 confirmed infections including nearly 3,000 deaths — has updated its travel advisory, ordering incoming international travelers to have a PCR test 48 hours before embarking on their trip to the country and two more tests, two days and seven days after arrival. Incoming international arrivals must also isolate for seven days.

Amid global concern over the omicron variant, the Nigeria CDC director-general told reporters that the country remains at alert in the face of the emerging crisis.

“We are working very hard to enhance ongoing surveillance, especially for inbound travelers, and also trying to ramp up testing (including) at the land borders,” he said.

A slew of nations moved to ban travels from many countries especially southern African nations in the aftermath of the emergence of the omicron variant. But the move has been widely condemned by many including South Africa President Cyril Ramaphosa, who is currently in Nigeria on a two-day visit.
…

On December 1, many mark World AIDS Day to show support for those living with HIV and to commemorate those who have died from an AIDS-related illness. Treatments have come a long way for those infected with HIV, but a cure is still elusive. VOA’s Laurel Bowman has our story.
…

NASA called off a spacewalk Tuesday because of menacing space junk that could puncture an astronaut’s suit or damage the International Space Station. 

Two U.S. astronauts were set to replace a bad antenna outside of the space station. But late Monday night, Mission Control learned that a piece of orbiting debris might come dangerously close. There wasn’t enough time to assess the threat so station managers delayed the spacewalk until Thursday. 

It’s the first time a spacewalk has been canceled because of threat from space junk. 

The space station and its crew of seven have been at increased risk from space junk since Russia destroyed a satellite in a missile test two weeks ago. 

It wasn’t immediately clear whether the object of concern was part of the Russian satellite wreckage. During a news conference Monday, NASA officials said the November 15 missile test resulted in at least 1,700 satellite pieces big enough to track, and thousands more too small to be observed from the ground but still able to pierce a spacewalker’s suit. 

NASA officials said astronauts Tom Marshburn and Kayla Barron faced a 7% greater risk of a spacewalk puncture because of the Russian-generated debris. But they said it was still within acceptable limits based on previous experience. 

Marshburn and Barron arrived at the space station earlier this month. 
…

A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. 

A Food and Drug Administration panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. 

The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on the FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age. 

The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated patients, who weren’t part of the study and haven’t been shown to benefit. 

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. The pill is already authorized in the United Kingdom. 

The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and U.S. officials brace for the arrival of the new omicron variant.

Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of the coronavirus. 

But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans. 

“With no data saying it works with new variants, I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug. 

Effectiveness, dangers

The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier. 

Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50% reduction it first announced based on incomplete results. 

That smaller-than-expected benefit amplified experts’ concerns about the drug’s toxicity for fetuses. 

FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused toxicity and birth defects when given at very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.” 

FDA is weighing a blanket restriction against any use in pregnant women or allowing it in rare cases. Some panelists said the option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options. 

Dr. Janet Cragan, who backed the drug, said that even with tight restrictions, some pregnant women would inevitably take the drug.

“I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.”

Merck’s drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. But FDA regulators said Tuesday that risk is theoretical and seems unlikely. 

Pfizer drug

While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill under review. 

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug. 

Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations. 

The U.S. government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir. 

Both drugs require patients to take multiple pills, twice a day for five days. 

 
…

Japan and France confirmed their first cases of the new variant of the coronavirus on Tuesday as countries around the world scrambled to close their doors or find ways to limit its spread while scientists study how damaging it might be.

The World Health Organization has warned that the global risk from the omicron variant is “very high” based on early evidence, saying it could lead to surges with “severe consequences.”

French authorities on Tuesday confirmed the first case of the omicron variant in the French island territory of Reunion in the Indian Ocean. Patrick Mavingui, a microbiologist at the island’s research clinic for infectious diseases, said the person who has tested positive for the new variant is a 53-year-old man who had traveled to Mozambique and stopped in South Africa before returning to Reunion.

The man was placed in quarantine. He has “muscle pain and fatigue,” Mavingui said, according to public television Reunion 1ere.

Japan on Tuesday confirmed its first case in a visitor who recently arrived from Namibia, a day after banning all foreign visitors as an emergency precaution against the variant. A government spokesperson said the patient, a man in his 30s, tested positive upon arrival at Narita airport on Sunday and was isolated and is being treated at a hospital.

Cambodia barred entry to travelers from 10 African countries, citing the threat from the omicron variant. The move came just two weeks after Cambodia reopened its borders to fully vaccinated travelers on Nov. 15.

The new version was first identified days ago by researchers in South Africa.

WHO said there are “considerable uncertainties” about the omicron variant. But it said preliminary evidence raises the possibility that the variant has mutations that could help it both evade an immune-system response and boost its ability to spread from one person to another.

The WHO stressed that while scientists are hunting evidence to better understand this variant, countries should accelerate vaccinations as quickly as possible.

Despite the global worry, doctors in South Africa are reporting patients are suffering mostly mild symptoms so far. But they warn that it is early. Also, most of the new cases are in people in their 20s and 30s, who generally do not get as sick from COVID-19 as older patients. 
…

U.S. President Joe Biden says a highly transmissible COVID-19 variant, dubbed omicron, is a cause for “concern, not panic” and defended his much-criticized decision to restrict travel from the southern African region, where it was first reported. VOA’s Anita Powell reports from the White House.

Produced by: Barry Unger
…