Stay alert about omicron but don’t panic

Journalists (and everyone else) would do well to remember that the doctor who has treated the most patients sick with the omicron variant of COVID-19 has so far seen quite mild cases among vaccinated people. The most severe cases have been among unvaccinated people, especially young unvaccinated people.

For people who are fully vaccinated, it appears at this early stage that this new variant is not a game-changer. But then again, the game may indeed change.

Rudo Mathivha, head of the intensive care unit at Baragwanath Hospital in Soweto, South Africa, told a news conference, “Young people, in their 20s to just over their late 30s, are coming in with moderate to severe disease, some needing intensive care. About 65% are not vaccinated and most of the rest are only half-vaccinated.”

The surge appears to have spread quickly after a cluster appeared at a university campus in the South African capitol of Pretoria. About 40% of South Africans are vaccinated and the percentage is even lower among young people.

Dr. Raghib Ali, an epidemiologist at the University of Cambridge, said:

1,300 omicron cases suspected, 2,000 confirmed

I put these figures in the headline to remind you that, compared to the number of new delta variant COVID-19 cases detected daily in the U.S., the number of omicron infections is still small. It is growing. But it is important not to ignore the wolf already at the door. 

Sweden, Spain, Scotland and Austria all reported cases Monday. The cases are all connected to people who had recently traveled from South Africa or southern African countries. South Africa has confirmed more than 100 cases and represents half of all of the confirmed omicron cases so far.

What happens to in-person gatherings in 2022 now?

At Poynter, I am working through decisions about when I can teach in-person seminars safely. I have plans to hold an in-person Covering Jails and Justice Reform seminar in January and, if I have to wait two weeks to know all I need to know about the omicron outbreak, it puts any last-minute changes at the actual last minute. For now, I am planning to go ahead but offer a virtual version, too.

You might check with your convention bureau and big hotels to see what planners are saying about plans for the first quarter of 2022 as of this week.

Other much larger decisions are pending:

• In January, the Consumer Electronics Show is planned to return to Las Vegas.
• The huge World Economic Forum is approaching in Davos.
• Then there are the Winter Olympics, scheduled to occur in February in Beijing. Like Japan did for the Summer Games, China will allow only mainland Chinese spectators. Who knows what travel restrictions will be in place by the time athletes have to travel?

How are hotels and airlines handling the current interruptions and travel restrictions?

FDA considers Merck’s new molnupiravir pill today

Beyond the dismal news about a new variant and potential new rise in COVID-19 cases, the Food and Drug Administration’s Antimicrobial Drugs Advisory Committee, an advisory panel that reviews and recommends new drugs, will meet Tuesday to look at Merck’s new drug. Molnupiravir has been shown to significantly cut the rate of hospitalizations and deaths among people with mild-to-moderate coronavirus infections.

But before you get too excited, there are some caveats. We got a look at Merck’s newest data on this drug over the weekend. Initially, Merck’s drug tests showed a 50% reduction in hospitalizations and deaths among patients with COVID-19. But a larger sample now shows a 30% reduction. Keep in mind that about 9% of infected patients end up in the hospital without the drug, which means about 7% of people might be hospitalized if the new drug is approved.

While the drug does not provide strikingly more protection against hospitalization and death, the advantage of this drug is that it is a pill and not an injection that would have to be administered in a hospital setting.

There are currently three FDA-approved antivirals or monoclonal antibodies that are injections.

• Remdesivir is for use when the patient has a severe case of COVID-19.
• Casirivimab, sotrovimab and bamlanivimab were all approved for mild to moderate COVID-19 cases. But the FDA pulled approval of bamlanivimab “due to a sustained increase in variants resistant to bamlanivimab alone resulting in increased risk for treatment failure.”  It once again points out why variants are such a concern for drug companies.
• One other drug, an antidepressant called fluvoxamine, has shown to have some potential to reduce hospitalizations and death among COVID-19 patients. It has been widely used for 30 years and is relatively inexpensive. The latest study on that drug involved more than 9,000 patients in Brazil, although several smaller studies have been performed in other countries.

Merck says its drug inserts tiny mutations into the coronavirus’ genetic code to the point that it can’t reproduce itself. The FDA will ask questions about what side effects that generic code change might cause, such as birth defects. No pregnant women were in the initial study group. The study did look at pregnant rats and rabbits, but the FDA staff report suggested “the known and potential benefits of MOV may not outweigh the known and potential risks of MOV in pregnant individuals. One option is to not authorize MOV for use in pregnant individuals.”

The drug has so far been studied in trial with 1,400 people who had tested positive for COVID-19. Compared to infected people who did not get the Merck pill, about 30% fewer people who took the pill required hospitalization. Keep in mind that means the pill is not a failsafe and not a cure-all. The test involved people who got the pill within five days of showing symptoms.

You can read the FDA’s staff report to the committee here. The FDA review points out that Merck’s drug trials are a fraction of the size that the FDA usually considers before approving a new drug.

There are some other antiviral medications that may be only a few weeks away from FDA approval. Pfizer has a new drug still being evaluated called Paxlovid that may cut hospitalizations and deaths among COVID-19 patients by 90%.

We’ll be back tomorrow with a new edition of Covering COVID-19. Are you subscribed? Sign up here to get it delivered right to your inbox.