September 27, 2022

Moderna seeks emergency use authorization for Covid-19 vaccine for children ages 6 months through 5 years

3 min read





CNN

Moderna is seeking emergency permission from the US Food and Drug Administration for the Covid 19 vaccine for children aged 6 months to 5 years, the company said on Thursday.

“We believe that mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is crucial in our ongoing fight against COVID-19, and especially parents and caregivers.” Those who do will welcome it, “said Stephen Bensell, chief executive. The Moderna official said in a news release.

In late March, Moderna announced the results of a clinical trial involving 2,500 children aged 6 months to 24 months and 4,200 children aged 2 to 5 years. The company said two to 25 micrograms of its vaccine caused a similar immune response in young children. Two doses of 100 micrograms for adults aged 18 to 25 years.

In Thursday’s news release, the company said the data showed “a strong neutral antibody response” and “a favorable safety profile.”

“We like to see anything above 1,000 units, and what we actually see here is between 1,400 and 1,800 units,” said Dr. Paul Burton, Moderna’s chief medical officer, on Wednesday. “So it’s very satisfying.”

Burton also said that vaccines are very safe for this age group. The most common reactions were pain and fever at the injection site. There were no cases of heartburn or myocarditis in the study. Heartburn has been a very rare side effect of the mRNA vaccine. Myocarditis is more common after COD-19 infection than after vaccination.

The results announced in March were mostly collected during the Omicron wave, and included home testing for the CoVID-19. As a result, the company says, these vaccines appear to be less effective for children than for older groups.

Moderna’s data presented on Thursday limited the analysis to only positively confirmed cases from sensitive reverse transcription-polymerase chain reaction tests. In the revised analysis, vaccines were 51% effective in preventing symptoms in children under 6 months of age. They were 37% effective in preventing symptoms in children aged 2 to 5 years. The company said that these efficacy estimates are similar to those against Omicron after two doses in adults.

Pfizer / BioNTech’s CoVID-19 vaccine for young children has also stumbled. In clinical trials, two 3-microgram doses Didn’t appear to be born. Children 2 to 4 years of age have the same immunity as young adults, which is why the company encourages children from 6 months to 4 years to be given a third dose. The FDA, too Delayed review. Of these shots until the company submits data on the third dose.

on Tuesday, Pfizer asked the FDA Give green light to one third or booster dose for children 5 to 11 years old. Studies have shown that vaccine efficacy in this age group is significantly reduced during Omecron.

Burton said Wednesday that Modern is also testing boosters, including a variety of specific formulations.

“Our main candidate now has something against the real tension and Omicron,” he predicted, adding that it would be a booster formulation for autumn and winter.

“And I think for those little kids, what do we have to do to keep following the natural history and see what’s different about it? What’s going on with the little ones when we come in the fall?” And then the FDA and CDC and regulators around the world can make recommendations on whether they need another booster at the end of the year.

No CoVID-19 vaccine has been approved for children under the age of 5 in the United States – approximately 18 million people.

Moderna’s mRNA Covid-19 vaccine is authorized for people 18 and older, and Pfizer / BioNTech’s 5 and older are authorized.

The FDA will review Moderna’s submission and has said it will call its advisory committee on vaccines and related biological products to consider approving vaccines for young children.

Dr. Anthony Fookie, director of the National Institute of Allergy and Infectious Diseases, says the FDA is considering whether to separate both the Moderna and Pfizer / Biotech covid 19 vaccines for young children at the same time. Instead of using it, consider using the emergency. .

Pfizer said data on a third dose of the vaccine would be available later this month. Pfizer CEO Albert Borla said the vaccine for young children could be available in June, if the FDA allows it.



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