New COVID-19 drugs may have limited impact fighting Omicron this winter

The Biden administration this week moved to calm the public about the Omicron variant, saying that it would quickly open additional vaccination sites and buy 500 million rapid test kits that could be sent to the public.

But scientists say the new variant could greatly reduce the effectiveness of existing therapeutic drugs. And the new drugs going before the FDA for approval might be of limited value.

The drugs include Pfizer’s Paxlovid, which was approved on Wednesday by the FDA for use in patients who have mild to moderate coronavirus disease. It can be used in patients who are 12 or older.

The Union-Tribune discussed the situation with Dr. Davey Smith, director of infectious diseases at UC San Diego. He also helps develop COVID-19 drugs.

Q: I was in New York City last week where I saw lots of people lining up for COVID-19 tests at street-corner testing stations. It made me wonder just how bad Omicron will be, and whether the new therapeutic drugs going before the FDA will be effective. What’s your take?

A: There are two issues — vaccines and treatments. People who considered themselves fully vaccinated after they got their two shots of the Pfizer or Moderna vaccines or the one shot of the J&J vaccine have not made enough antibodies to protect themselves from Omicron. So, they need to get a booster shot. The second thing is that the monoclonal drugs from Regeneron and Lilly that are now being used probably won’t be as effective against Omicron.

At the moment, we aren’t at a point where we can simply call our doctor and have him or her have our pharmacist provide us with a drug if we test positive for COVID. But I hope we’ll be there in three or four months.

Q: Will it be immediately obvious that the Regeneron and Lilly drugs won’t be as useful as they’ve been so far?

A: Scientists have tested these drugs in the lab and it looks like they lose a lot of their efficacy. In people, we don’t yet know what will happen. It’ll take time to see if there are increased hospitalizations after people take these drugs. It’s possible that the drugs might have some efficacy that we did not see in the lab.

Q: Four companies — Pfizer, Merck, Brii Biosciences and AstraZeneca — have developed new anti-COVID-19 drugs. They have, or will soon seek, approval from the FDA. Will these drugs make a big difference in the fight against COVID-19?

A: They’ll be presenting their data to the FDA over the next few weeks. Merck already did that. The panel reviewed the data and there was a close split; 13 of the reviewers thought it was good, 10 didn’t. The FDA will take that advice and decide whether to issue an emergency use authorization (EAU). I thought we would have a decision by now. I hope they’re scrutinizing the data closely so that they get the decision right.

Q: What is your take on the Merck drug, which is called Molnupiravir?

A: The data are mixed. I can see why half of the reviewers basically didn’t like it. To me, it doesn’t show very good impact with the Delta variant. We have no idea whether it will be effective with Omicron, which appears to be more transmissible than Delta.

Q: What about the Pfizer drug Paxlovid?

A: Yes, FDA approved it. The agency probably felt some pressure to do that because there is no other drug out there for this purpose. But they have yet to release the full scientific data behind it. The initial data looks great.

Q: What about the new Evusheld drug from AstraZeneca and the drugs Brii-196 and Brii-198 from Brii?

A: Both of them seem to have some effect against Omicron. Not great, but some. The FDA also might feel some urgency to get some new anti-monoclonal drugs approved.

Q: Would the drugs get to places like San Diego quickly if they’re approved by the FDA?

A: Yes. The U.S. government would buy a bunch of that supply and send it out to anti-monoclonal centers and hospitals in San Diego.

Q: Is there any news about therapeutic drugs that should make us feel better as we go into this surge of Omicron?

A: Not really. More therapies are being tested, which is good. But I’m a little pessimistic about the winter because Omicron really has knocked out some of the best therapies that we have at the moment to keep people out of the hospital, and to keep them from dying. We don’t have a lot to fight Omicron with over the winter.

Q: The Biden administration said Tuesday that it will purchase 500 million rapid COVID-19 tests to give, without charge, to the public. Will that have an important impact?

A: It could. One of the biggest things you can do with infection control is to know whether people are infected, right? People will decide to do things like not going home to see their parents if they’re infected, or not send their kids to school if the kids are infected. Yes, this could really help.

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