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FDA doubles COVID-19 monoclonal antibody dosage, access and supply are concerns

AstraZeneca
Posted at 10:50 PM, Feb 28, 2022
and last updated 2022-02-28 22:50:46-05

(WXYZ) — The Food and Drug Administration has doubled the dosage of a monoclonal antibody that helps prevent COVID-19.

New data suggests the drug could be less active against omicron subvariants, but upping the dose bumps up protection.

The drug is called Evusheld and it’s made by AstraZeneca. It combines two human monoclonal antibodies, tixagevimab and cilgavimab. The cocktail is authorized for use in people over the age of 12. But only for those who are immunocompromised or can’t get vaccinated because of medical reasons, like if they’re allergic to a vaccine ingredient.

Now, when Evusheld was granted emergency use authorization back in early December, delta was the dominant variant. And the treatment was said to boost immunity for up to one year. But as we all know, that changed as omicron is now the dominant variant. And new data found that protection against symptomatic disease from omicron may not last as long as it did in clinical trials with previous variants.

Fortunately, research found a higher dose of Evusheld can enhance protection. And it’s more likely to prevent infection from BA.1 and BA.1.1 — these are the two omicron subvariants currently circulating. As for omicron’s stealth variant, BA.2, it hasn’t spread as quickly here in the U.S. and currently only accounts for a small percentage of cases. However, scientists expect that Evusheld will have a greater neutralizing activity against this sublineage if BA.2 does spread at a faster pace in the future.

The government initially purchased 700,000 doses of Evusheld, of which 600,000 have been shipped. An additional 500,000 doses have been ordered, which is good. But there are roughly 7 million Americans who are immunocompromised. So, while there are supply challenges, it’s important that anyone who’s been given the initial lower dose go back for a second dose right away. And anyone who feels that they meet the criteria for this monoclonal antibody should not be discouraged from talking to their healthcare provider about it.

Now I know our case numbers are down and the Centers for Disease Control and Prevention changed their mask recommendations. But I’m concerned for those who are immunocompromised. They should not let their guard down. Please take extra precautions because people who have a moderately to severely compromised immune system are more vulnerable to the virus overall.

Additional Coronavirus information and resources:

View a global coronavirus tracker with data from Johns Hopkins University.

See complete coverage on our Coronavirus Continuing Coverage page.