Moderna says its vaccine triggers immune response in teenagers, will seek FDA approval

A health-care worker administers the Moderna coronavirus vaccine at the American Museum of Natural History vaccination site in New York on April 30. (Gabby Jones/Bloomberg)

By Katerina Ang, Erin Cunningham and Derek Hawkins

Biotechnology company Moderna announced Tuesday that its two-shot coronavirus vaccine produced the same immune response in teenagers as adults, and it plans to submit the data to U.S. regulators in early June.

If authorized, the vaccine would become the second available for adolescents as young as 12. Pfizer-BioNTech’s vaccine was authorized for that age group earlier this month.

Here are some significant developments:

*The United States called Tuesday for the swift launch of a follow-up investigation into the origins of the pandemic, amid growing concerns over China’s lack of transparency about the early days of the outbreak. Health and Human Services Secretary Xavier Becerra, speaking in a video message, urged an annual ministerial meeting of the World Health Organization to establish a second stage of the investigation that took place in the Chinese city of Wuhan earlier this year.

*Vaccine safety experts are studying a small number of cases of myocarditis, heart muscle inflammation, among young people who had recently received their second dose of one of the coronavirus vaccines. No formal link has been established.

*The U.S. Olympic & Paralympic Committee will send a delegation of athletes to the Tokyo 2020 Games this summer despite the State Department’s new advisory warning Americans against visiting Japan.

*The two largest school systems in the United States, in New York City and Los Angeles, will fully reopen for in-person learning this fall, officials announced Monday, a major step in the country’s pandemic recovery.

*Melbourne introduced new social distancing measures on Tuesday, as Australia’s second-largest city moved to quash a small coronavirus outbreak. Victoria, the state Melbourne is in, had been covid-free for almost three months.

*The number of new coronavirus cases continued to fall in the United States. Nearly 21,000 new infections were reported Monday, down 23 percent over the past week.

Biotechnology company Moderna announced Tuesday that its two-shot coronavirus vaccine produced the same immune response in teenagers as it does in adults, and it plans to submit the data to U.S. regulators in early June.

If authorized, the vaccine would become the second available for adolescents as young as 12. Pfizer-BioNTech’s vaccine was authorized for that age group earlier this month.

In Moderna’s clinical trial, 3,732 adolescents, ages 12 to 17, received two shots of the vaccine or a placebo. Researchers used blood tests to measure the immune response triggered by the vaccine. They found antibody levels equivalent to those of adults who were protected against illness.

There were four cases of covid-19 with symptoms that met the criteria in the adult trial. All the cases were in the group that received the placebo. When researchers used a looser definition, that included only a single symptom and a positive nasal swab test, the vaccine was 93 percent effective.

The vaccine had tolerable side effects, including sore arms, headaches, fatigue, chills, and muscle aches. The data have not yet been peer-reviewed or published in a medical journal.

Trials in younger children are ongoing for both Moderna and Pfizer-BioNTech but are expected to take longer, because researchers must ascertain a safe and effective dose, which may be different from the one used in adults.

About Carma Henry 19700 Articles
Carma Lynn Henry Westside Gazette Newspaper 545 N.W. 7th Terrace, Fort Lauderdale, Florida 33311 Office: (954) 525-1489 Fax: (954) 525-1861

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