Modern COVID-19 vaccine seems to work in older adults in the early study as well


By Julie Steenhuysen and Manojna Maddipatla

(Reuters) – Moderna Inc said on Wednesday that its experimental COVID-19 vaccine is causing immune reactions in older adults like those in younger participants, and hopes to offer that it will be effective in people who are considered at high risk for serious complications. of the coronavirus.

The company is one of the leading candidates in the race to develop a vaccine against the virus that has killed more than 820,000 people worldwide. Its candidate, mRNA-1273, is already in late-stage human trials to test its ability to safely prevent infection.

The latest data from an early phase I study include an analysis of 20 additional people detailing how the vaccine was performed in older adults.

The analysis looked at subjects given the 100-microgram dose tested in the much larger Phase III trial. Moderna said the immune responses were similar in those between 56 and 70, older than 70 and those 18 to 55 years old.

Health officials have raised concerns about whether vaccine candidates would work in older people, whose immune systems typically do not respond as strongly to vaccines.

Modern shares, which have more than tripled this year, rose about 6% after the release of the data.

The company has so far enrolled more than 13,000 participants in its late-stage study. About 18% of the total participants are Black, Latino, Native American or Alaska Native, groups that have been particularly hard hit by the pandemic, and are often under-represented in clinical trials.

Dr. Jacqueline Miller, head of Moderna’s development of infectious disease, told a panel of the U.S. Centers for Disease Control and Prevention (CDC) that the company plans to post weekly updates on enrollment of Black and Latino subjects on its website.

Pfizer Inc. told Reuters last week that 19% of the 11,000 test subjects already enrolled in their vaccine test are black or Latino.

Miller said the demographic format of Moderna’s process is a frequent topic at meetings with U.S. officials at the head of the White House program, aimed at accelerating COVID-19 vaccine development and treatments.

DEEP FREEZE

Businesses and health officials are also working on ways to disperse COVID-19 vaccines, some of which need to be sent and stored at extremely cold temperatures.

Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, questioned Pfizer’s plans after the company said its vaccine should be stored at ultra-low temperatures for up to 6 months or in specially designed shipping containers for up to 10 days,

Once removed from the containers, the vaccine can be stored for up to a day at temperatures between 2 and 8 degrees Celsius (36-46 ° F) – about the temperature of a normal refrigerator – or 2 hours at room temperature.

“The complexity of this vaccine storage and disposal plan will have a major impact on our ability to deliver the vaccine efficiently,” Messonnier said.

Pfizer told the CDC panel that it is working to make the vaccine stable at higher temperatures. Pfizer shares were down about 1.5%.

The Moderna vaccine should be kept at minus 20 degrees Celsius for shipment and longer-term storage of up to six months, but it can be stored for up to 10 days at regular cooling temperatures. The vaccine will be distributed in 10-dose vials without preservatives, the company said.

Moderna is also working to make the vaccine stable at higher temperatures, Miller said.

Moderna, which has never marketed a vaccine, has received nearly $ 1 billion from the US government under its Warp Speed ​​program. It also signed a $ 1.5 billion supply agreement with the United States.

(Report by Manojna Maddipatla in Bengaluru; Additional Reporting by Ankur Banerjee and Michael Erman; Edited by Jonathan Oatis, Peter Henderson and Bill Berkrot)