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www.fdanews.com/articles/198747-modernas-covid-19-vaccine-may-be-safe-and-effective-in-elderly-patients-data-shows

Moderna’s COVID-19 Vaccine May Be Safe and Effective in Elderly Patients, Data Shows

August 27, 2020

Moderna’s coronavirus vaccine candidate was well-tolerated and worked well in elderly COVID-19 patients in a small, early-stage trial, the company said Wednesday, following promising results announced in July for younger patients.

The vaccine, mRNA-1273, was given as a double 100 microgram dose two weeks apart to 10 patients aged 56 to 70 and 10 others above the age of 70, and it elicited neutralizing antibodies and T cells, the company said. The amounts of antibodies produced were two to three times higher than those seen in previously infected COVID-19 patients.

The data, which has not yet been published in a medical journal, also showed that the vaccine caused no serious adverse events. The majority of local and systemic symptoms were mild to moderate, and most resolved within two days, the company said.

 “Neutralizing antibody titers and T-cell responses in the 56-70 and 71+ age cohorts were consistent with those reported in younger adults,” Moderna CEO Stéphane Bancel said during a conference call. Bancel characterized the new findings as “very important” data that could potentially crown its vaccine candidate as best in class.

The positive data echoes phase 1 trial data unveiled by the drugmaker last month that showed the vaccine generated high levels of neutralizing antibodies in 45 healthy adults aged 18 to 55 (DID, July 15).

Moderna expects to finish enrolling patients in its 30,000 participant late-stage trial of the vaccine in September. As of Tuesday, the phase 3 trial had 15,239 people enrolled, the drugmaker said.

It announced prices between $32 and $37 per dose for smaller-sized vaccine supply agreements earlier this month. Moderna didn’t elaborate on prices for higher volume deals but said they would be lower (DID, Aug. 6).

The company said it is on track to be able to produce 500 million to 1 billion 100 mcg doses of the vaccine per year. — James Miessler