December 2021

White House Chief Medical Adviser Anthony Fauci said Friday it should be about two weeks before scientists fully understand how transmissible and severe the omicron variant of the coronavirus that causes COVID-19 truly is, and until then, people need to get vaccinations and booster shots. 

During a briefing by the White House COVID-19 Response Team, Fauci said South African researchers are leading the way but even their studies will take another week or two to get clinical data. The omicron variant was first identified in South Africa and there are more and longer-term cases to study there, he said. 

The White House response team repeated a message delivered earlier this week by President Joe Biden, that omicron is a variant of concern. Fauci presented new data showing both the Moderna and Pfizer-BioNTech vaccines are markedly boosting antibodies and stressed the need for people to get vaccinated. 

U.S. Centers for Disease Control and Prevention Director Rochelle Walensky said her agency is working with health departments across the United States to help them quickly conduct the genome sequencing necessary to isolate and identify the omicron variant. She said the CDC is far more effective at this process than it was earlier this year. 

Walensky stressed that while the focus is on the omicron variant, the delta variant of the virus is dominant in the U.S. and responsible for 99.9 percent of all cases in the country, especially among the unvaccinated.

White House COVID-19 response coordinator Jeff Zients told reporters that 2.2 million vaccinations – including more than one million boosters – were administered in the U.S. on Thursday, the highest single-day total since May.

Zients said Biden has outlined areas where his administration is taking action to address the potential threat posed by the omicron variant, including vaccinations and boosters for adults, getting kids vaccinated, providing free home testing kits, strengthening travel rules and getting the rest of the world vaccinated.

To the last point, Zients said the U.S. has donated 1.2 billion doses of vaccine for global distribution, more than all other nations combined. Friday alone, he said, the U.S. shipped 11 million doses of vaccine, nine million of which were designated for Africa. 

 
…

The World Health Organization has recognized Botswana for its efforts to prevent the transmission of HIV from expectant mothers to unborn children. Officials say no children born to HIV-positive mothers this year had the virus.

WHO awarded Botswana the ‘silver tier’ status this week; The silver tier certification is given to countries that have lowered the mother-to-child HIV transmission rate to under five percent and provided prenatal care and anti-retroviral treatment to more than 90 percent of pregnant women.

Botswana has achieved the WHO’s target of an HIV case rate of fewer than 500 per 100,000 live births.

WHO regional director for Africa Matshidiso Moeti, in awarding the certificate in Gaborone on Thursday, said Botswana has demonstrated that an AIDS free generation is possible.

“I want to applaud, this is huge accomplishment by Botswana, which we know has one of the most severe HIV epidemics. This achievement demonstrates that an HIV/AIDS free generation is possible. It also marks an important step towards ending AIDS across the entire continent. Perhaps most importantly, it illustrates the remarkable progress that can be achieved when the needs of mothers living with HIV and their children, are prioritized.”

Botswana has the world’s fourth highest HIV prevalence but has made strides in fighting the virus.

President Mokgweetsi Masisi says the award recognizes the country’s progress towards an HIV-free generation.

“The award is given to Botswana and Batswana as testimony for the success of our efforts as a country in the path to eliminate mother-to-child transmission of HIV. We are excited by this development because we have been battling the HIV/AIDS pandemic for many years. The award therefore, which is the first to be awarded to an African country, demonstrates that our efforts have not been in vain,” Masisi said. Also noting that HIV rate significantly decreased from 37.4 percent in 2003 to 18.4 percent in 2019.

HIV-positive young women, like Tlotlo Moilwa, say the country is on a reassuring path.

“The reasons that drive this change is that the moment a woman is pregnant, they are also tested for HIV and if the result is positive, at that very moment, they enroll for prevention of mother-to-child transmission. This means they cannot infect the unborn baby or even during birth,” Moilwa expressed.

With the country making strides in preventing mother-to-child HIV transmissions, Moilwa says the future is much brighter for her and other HIV-positive women.

“I see a huge change for our future. If you look at the youth living with HIV at the moment, a lot of them got infected at birth. If right now babies are born HIV negative, it means that there will not be HIV positive young people in the future if we are to take care of ourselves.”

According to WHO, 15 countries globally, have been certified for eliminating mother-to-child HIV transmission, but none had an epidemic as large as Botswana. 
…

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. 

 
…

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. 
…

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.
…

Herd immunity is when a significant portion of a community is immune to an infectious disease, making it harder for the disease to spread.
…

The top U.S. infectious disease expert said Tuesday that vaccinated Americans have “some degree of protection” against the new omicron variant of the coronavirus, but that scientists will not know for a few weeks how vaccines may need to be altered to best fight it. 

Dr. Anthony Fauci, President Joe Biden’s top medical adviser, said at a White House coronavirus news briefing that the omicron “mutation profile is very different from other variants” of the coronavirus. 

While he said the three existing vaccines used in the U.S. could prevent people who have been inoculated from getting seriously ill from the omicron variant, it “remains uncertain … speculative” whether they will fully work against people getting sick. 

“We believe it is too soon to tell about the severity” of the omicron variant, he said. “We should have a much better idea in the next few weeks.” 

To date, he said, 226 cases of the omicron variant have been identified in 20 countries across the globe, but none so far in the United States. Health officials, however, say they assume the variant eventually will spread to the United States. 

“We are actively looking for the omicron variant in the U.S.,” said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention. 

Stephane Bancel, chief executive of Moderna, which produces one of the vaccines used in the U.S., predicted in an interview with the Financial Times that existing vaccines would be much less effective in combating the omicron variant than the previous four variants of the coronavirus. 

“There is no world, I think, where (the effectiveness) is the same level … we had with delta,” Bancel said, referring to the highly contagious variant that is the predominant strain throughout the U.S. and was first detected in India in late 2020. 

His comments sent U.S. stock indexes tumbling, as investors feared the effect of the omicron variant on the world economy, in which many countries are still struggling from the coronavirus onslaught that started in early 2020. 

Bancel said it could take months for pharmaceutical companies to manufacture effective new vaccines to deal with the specific molecular makeup of the omicron variant. 

Dutch officials said Tuesday that they detected the omicron variant in tests almost two weeks ago, days earlier than when two flights from South Africa transported infected passengers to the Netherlands. 

Walensky said 45 million adults are unvaccinated in the U.S., and millions more children, ages 5 to 18, are eligible to get shots, but their parents have yet to get them inoculated. 

In addition, Jeffrey Zients, the White House COVID-19 response coordinator, said that 100 million vaccinated people in the U.S. are eligible for booster shots but have yet to get them.

He, too, said that vaccinations provide “some protection” against the omicron variant and that “boosters help that.” 

“We want to make sure Americans are doing all they can to protect themselves,” he said. 

 
…

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. 

 
…