The FDA has doubled the dose of Covid-19 monoclonal antibody, raising access and supply concerns

Naomi Thomas, CNN

Thursday US Food and Drug Administration revision An emergency use authorization for Evusheld, a monoclonal antibody against Covid-19 for people with weakened immunity or who cannot be vaccinated for medical reasons, doubles the initial dose. Those who have already received the drug should return for additional doses as soon as possible, the agency said.

“Based on the latest information and data available, Evusheld may not be very active for certain Omicron subvariants. The available data are COVID-19 Omicron subvariants BA.1 and BA. The dosing regimen has been revised to indicate that it is more likely to prevent infection with .1.1 at higher doses than the initially approved Ebshelled dose, “the FDA said in the news. release.

The drug protects people who cannot get the Covid-19 vaccine

Evusheld USA On December 8, it was approved as pre-exposure prophylaxis for the prevention of Covid-19 in certain people over the age of 12 with moderate to severe immune system impairment due to medical conditions. It is an immune system and may not provide a sufficient immune response from the vaccine. Or if you are advised not to vaccinate because of a severe reaction to the Covid-19 vaccine or its ingredients.

Previously, Evusheld was allowed to inject 150 milligrams (mg) of tixagebimab and 150 mg of cilgavimab into the muscle twice and repeat every 6 months while the coronavirus was circulating. .. With the revision, the FDA has increased the initial dose to 300 mg for both tixagebimab and cilgavimab.

“Patients who have already received previously approved doses (150 mg tixagebimab and 150 mg cilgavimab) should take an additional dose of 150 mg tixagebimab and 150 mg cilgavimab as soon as possible to raise the monoclonal antibody level to the expected level. Patients receiving higher doses that need to be received, “said the FDA.

Protection against symptomatic treatment may not last as long as clinical trials have shown, as data were obtained before the advent of BA.1 and BA1.1, the FDA said.

It’s not clear if these subvariants are still in circulation in the coming months, or if another subvariant will prevail, the FDA pointed out. It showed an example of BA.2 sublineage in which Evusheld is expected to have greater neutralizing activity. For this reason, the FDA cannot provide recommended timing for repeated doses, but states that it will continue to monitor the situation and provide information if more data is available.

Good news and bad news

Dr. Dolly Segev, a professor of surgery at Johns Hopkins Medicine, told CNN.

“I think it’s great to remember that the whole pandemic is basically built while flying, and I’ve been studying this particular monoclonal antibody, studying all these monoclonal antibodies, and The effects of these monoclonal antibodies on new variants, or perhaps variants, are their effectiveness, “he said. “And I think it’s great that the new data has identified the ideal dose that needs to protect people with immunodeficiency. In fact, it’s reassuring that protection will be done with the new dose. It’s great. That is. “

However, there are challenges.

“Of course, the tricky part is to let everyone who is already taking it know that it’s important to supplement it to be more effective against new varieties, especially Omicron,” Segev said. Told. “It is also important to continue to convey that seeking this remedy for people with weakened immunity is important for those who will benefit from it.”

Segev also mentioned the supply and distribution challenges for Evusheld.

The U.S. government has almost shipped 600,000 According to the US Department of Health and Human Services, Evusheld courses will be available nationwide from December 13th. In January, the government announced an additional purchase 500,000 The dose of Evusheld made by AstraZeneca.

The Centers for Disease Control and Prevention It is estimated that about 2.7% of adults in the United States have immunodeficiency. This is equivalent to about 7 million people.

“For those who need it, access to this product is already inadequate and it will now be more difficult,” Segev said. “Of the remaining dose, we basically need to cut it in half in terms of being available to real people.”

Need more dose of Evusheld

Catherine Rontok, Director of Science and Policy Communication Immunodeficiency FoundationEvusheld said it fills a significant gap for people who suffer from primary immunodeficiency and may not develop a protective response to the Covid-19 vaccine.

“It is important to adjust the dose of Evsheld as needed to provide meaningful protection to those treated with this treatment who are moderately to severely immune-protected from the currently circulating viral variants. We commend the FDA for its action to quickly generate data on the latest variants and renew product approvals to provide patients with the best possible protection, “she said in an email. I told CNN.

“On the other hand, doubling the dose will result in even less treatment, and patients with primary immunodeficiency will have access to treatment, even if the federal government purchases an additional 1 million doses and accelerates distribution. I keep hearing that I’m having a hard time. Schedule to the state. “

Dr. Brian Kofman, Co-founder, Executive VP, Chief Medical Officer CLL AssociationTells CNN in an email: We need it more and we need to distribute it quickly and fairly.

“While this change in recommendations makes the situation more complex and frustrating, the fact remains that many immune defenses can benefit from pre-exposure prophylaxis.”

For those who already have monoclonal antibodies, the double dose has raised concerns about availability and access.

Dr. Vivian ChanA professor of pediatrics at the University of Michigan School of Medicine, has a rare hereditary disorder that requires immunosuppressants. She received her first dose of Evusheld in January.

“We are far from getting enough doses at low doses,” she said. “Now everyone says they need to take it twice every six months, so take it four times a year. At the current dose, this covers everyone who needs it. There is no way to do it. “

Increasing the dosage also widens the gap between those who can do whatever they can to get the medication and those who, for a variety of reasons, do not know or know about Evusheld and cannot access it.

For Cheung, getting the first dose of Evusheld is not easy, and getting the second dose also seems difficult.

“I wrote to all the doctors, but only one came back and said,’Let’s see what I can do,'” she said. “I’m very privileged in many ways. I’m a doctor, an RNA biologist, and I know a lot of people who can help me navigate the medical system, but only one is back. He came and said, “Let’s see what I can do.” “”

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