Moderna

2022 - 4 - 28

Post cover — Image courtesy of "CP24 Toronto's Breaking News"

Moderna prepares to seek Health Canada COVID-19 vaccine ... (CP24 Toronto's Breaking News)

Moderna says it's working on a submission to Health Canada for the approval a COVID-19 vaccine for children under the age of six.

It's not clear if FDA will consider Moderna's vaccine for children of all ages now or focus first on the littlest. About 475 children younger than 5 have died from COVID-19 since the pandemic's start, according to the CDC, and child hospitalizations soared at omicron's peak. Yet it's not clear how many parents intend to vaccinate the youngest kids. But depending on how researchers measured, the vaccine proved at best about 51% effective at preventing COVID-19 cases in babies and toddlers and about 37% effective in the 2- to 5-year-olds. Other countries have expanded the shot to kids as young as 6. “Down the road I would anticipate it's going to be a three-shot series.” Another issue: So far in the U.S., Moderna's vaccine is restricted to adults. In a statement Thursday, the FDA said it will schedule a meeting to publicly debate Moderna's evidence with its independent scientific advisers but that the company still must submit some additional data. If it turns out they weren't protected in the Pfizer study and Moderna's shots are cleared first, Dunphy-Daly said she'd seek them for her sons. Pfizer is soon expected to announce if three of its even smaller-dose shots work for the littlest kids, months after the disappointing discovery that two doses weren't quite strong enough. There were no serious side effects, and the shots triggered fewer high fevers than other routine vaccinations. About 41 per cent of Canadian children in this cohort have had two shots according to federal data.

Moderna seeks emergency use authorization for Covid-19 vaccine ... (CNN)

Moderna is seeking emergency use authorization from the US Food and Drug Administration for its Covid-19 vaccine for children 6 months through 5 years of ...

Pfizer CEO Albert Bourla said the vaccine for younger children could be available in June, If the FDA authorizes it. The FDA will evaluate Moderna's submission and has said it will convene its Vaccines and Related Biological Products Advisory Committee to weigh in on vaccine authorization for younger children. The company said that two 25-microgram doses of its vaccine led to a similar immune response in young children as two 100-microgram doses for adults ages 18 to 25. "And I think for these young kids, what we'll have to do is to continue to follow the natural history and see, what is the variant? No Covid-19 vaccines have been authorized for children younger than 5 in the US -- about 18 million people -- and a timeline to potential authorization is not yet clear. The company said these efficacy estimates are similar to those among adults against Omicron after two doses.

Moderna expects to seek Canadian approval of COVID-19 vaccine ... (CBC.ca)

Moderna says it's working on a submission to Health Canada for the approval a COVID-19 vaccine for children under the age of six.

Other countries have expanded the shot to kids as young as six. But months ago the FDA cited concern about a rare side-effect, heart inflammation, in teen boys, and it hasn't ruled on Moderna's earlier pediatric applications. "Down the road I would anticipate it's going to be a three-shot series." He said safety data from millions of older children given Moderna vaccinations abroad should help reassure parents. If it turns out they weren't protected in the Pfizer study and Moderna's shots are cleared first, Dunphy-Daly said she'd seek them for her sons. Burton blamed the Omicron variant's ability to partially evade vaccine immunity, noting that unboosted adults showed similarly less effectiveness against milder Omicron infections. In a statement Thursday, the FDA said it will schedule a meeting to publicly debate Moderna's evidence with its independent scientific advisers but that the company still must submit some additional data. There were no serious side-effects, and the shots triggered fewer fevers than other routine vaccinations. Pfizer is soon expected to announce if three of its even smaller-dose shots work for the littlest kids, months after the disappointing discovery that two doses weren't quite strong enough. About 41 per cent of Canadian children in this cohort have had two shots, according to federal data, while 56 per cent have received at least one dose. And they need to do so swiftly. The long-awaited move is another stride toward potentially opening shots for millions of tots by summer.

Moderna asks FDA to authorize first COVID-19 vaccine for very ... (NPR)

Moderna announced Thursday that the company has asked the Food and Drug Administration to authorize a low-dose version of its COVID-19 vaccine as the first ...

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Moderna Asks the F.D.A. to Authorize Its Vaccine for Children Under 6 (The New York Times)

The company has also requested authorization of its Covid vaccine for 6- to 11-year-olds and 12- to 17-year-olds.

Moderna’s clinical trial data showed that the antibody response of the youngest children compared favorably with that of adults ages 18 to 25, meeting the trial’s primary criterion for success. He said the Omicron variant accounted for about 80 percent of infections in the study group. The F.D.A. has promised to ask its outside advisory panel of experts to review the data before the agency authorizes any vaccine for the youngest children. Moderna is proposing a two-dose regimen for children up to 6 years old, using one-fourth the strength of an adult dose. Both Moderna and Pfizer found that, compared with other, earlier trials, their vaccines’ effectiveness against infection plunged in clinical trials for young children, which were carried out largely during the winter Omicron surge. Pfizer and BioNTech are working on a three-dose regimen for those 6 months up to 5 years old, at one-tenth the strength of the adult dose. He said he hoped that the agency would “carefully and appropriately assess the data and not hold it up.” He added: “They’ll do the right thing. Those results were slightly better than the ones Moderna previously released for children under 2. Outside experts said even a rapid review of Moderna’s application could take until June. By then, Pfizer and BioNTech, its German partner, are likely to have completed their own application for pediatric doses covering children six months to 4 years old. The development, which was expected, could intensify pressure on federal regulators to authorize a vaccine for the nation’s youngest children. Meetings of the panel that were tentatively scheduled for May have now been moved to June, suggesting that no regulatory decision will come next month. A top official said the firm would finish submitting data to regulators by May 9.

Moderna's promised vaccine production facility to be built in ... (Coast Reporter)

OTTAWA — American vaccine maker Moderna will announce Friday it intends to build its promised Canadian production facility in Montreal.

Another $173 million went to Medicago in Quebec to help it develop a COVID-19 vaccine and expand production capacity. It was called a 10-year, multi-billion dollar deal between the company and Australia but no specific details on costs were provided for commercial secrecy reasons. It did not have its own commercial production capacity and contracted with Swiss firm Lonza to make its vaccines at first. The plant is finished but production lines aren't yet rolling as the building undergoes lengthy quality assurance procedures. That decision would largely depend on the availability of trained workers, he said. In a statement Thursday, Moderna said only that it is "still finalizing an agreement to construct a biomanufacturing facility in Canada."