FDA approves first COVID-19 antibody drug for long-term prevention – National – .

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FDA approves first COVID-19 antibody drug for long-term prevention – National – .


Federal health authorities on Wednesday cleared a new drug based on COVID-19 antibodies for people with serious health conditions or allergies who may not receive adequate protection from vaccination.

Antibody drugs have been a standard treatment for treating COVID-19 infections for over a year. But the AstraZeneca antibody drug cleared by the Food and Drug Administration is different. It is the first intended for long-term prevention against COVID-19 infection, rather than short-term treatment.

People who might benefit from the antibody drug include cancer patients, organ transplant recipients, and people taking immunosuppressive drugs for conditions such as rheumatoid arthritis. Health experts estimate that about two to three percent of the American population belongs to this group.

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“These people should always shelter in place because they are at a very high risk of serious illness and death,” Dr. David Boulware of the University of Minnesota said before the announcement. “So having this therapy will allow a lot of them to get back to normal life. “

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Specifically, the FDA has cleared the AstraZeneca drug called Evusheld for adults and children 12 years of age and older whose immune systems have not responded adequately to COVID-19 vaccines or who have a history of severe allergic reactions to them. injections. Regulators have said the two required antibody injections could be effective in preventing COVID-19 infections for six months.

Like similar drugs, AstraZeneca provides laboratory-made versions of human antibody proteins, which help the immune system fight viruses and other infections.

The FDA and other health authorities have stressed that antibody-based drugs are not a substitute for vaccines, which are the most effective, long-lasting, and cost-effective form of protection against viruses. Antibody drugs are difficult to manufacture and often cost over $ 1,000 per dose compared to vaccines which typically cost less than $ 30 per injection.


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Merck Canada announces its COVID-19 antiviral treatment to be manufactured in Ontario


Merck Canada announces its COVID-19 antiviral treatment to be manufactured in Ontario

The FDA has cleared three other antibody therapies from Regeneron, Eli Lilly, and GlaxoSmithKline, with the US government purchasing hundreds of thousands of doses. All require an IV or an injection. They are used to treat people with recent infections who are at the highest risk of developing to severe COVID-19 due to other health problems. Both can be used to prevent infection after possible exposure to the coronavirus.

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AstraZeneca’s drug is said to be used differently – only as a long-term preventative measure in people who have an increased vulnerability to the virus.

In a study by the company, people who received Evusheld had a 77% lower risk of infection than people who received a sham injection for six months, the FDA said.

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© 2021 The Canadian Press



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