Initial data on a possible COVID-19 vaccine shows that it triggered an immune response in the 45 people tested, researchers announced Tuesday.
Preliminary results of the study, published in the New England Journal of Medicine, were viewed with caution as a significant step in rapidly developing a vaccine against a virus that has closed countries and economies around the world and killed more than 576,000 people to the moment, including more than 136,000 in the United States.
The experimental drug, administered in two doses, was developed by Moderna Therapeutics, based in Cambridge, Massachusetts, and endorsed by the National Institutes of Health, which began safety tests on 45 subjects in March.
“No matter how this is cut, this is good news,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, a division of NIH, told the Associated Press.
The vaccine that Moderna is developing, mRNA-1273, is one of more than 155 vaccines, 23 of which are in human clinical trials, are being tested and developed worldwide in hopes of stopping the global pandemic.
Moderna is one of six companies that have received significant funding from the federal government to develop a vaccine, part of a $ 4 billion initiative called “Operation Warp Speed.” Moderna has received more than $ 500 million as part of the effort.
The Phase 1 study showed that two doses of the vaccine were able to trigger the production of “neutralizing” antibodies that can help prevent future infections in the 45 people tested. While the study concluded that the virus was safe, some people experienced mild side effects, such as fatigue, chills, headaches, and muscle aches, common symptoms experienced by people with COVID-19.
On Tuesday, Moderna released an announcement about its phase 3 clinical trial, scheduled to begin on July 27. That trial, dubbed the COVE study, will test 30,000 healthy people to see how effective the vaccine is at preventing coronavirus infections versus control subjects receiving a placebo. The study will also take a closer look at whether the possible vaccine could affect adults. older or those with chronic conditions.
Another Pfizer-led Warp Speed effort is also expected to begin testing Phase 3 in July.
“This positive Phase 1 data is encouraging and represents an important step forward in the clinical development of mRNA-1273, our vaccine candidate for COVID-19,” said Stéphane Bancel, CEO of Moderna, in a statement.
While drug companies and governments around the world have been quick to find an effective vaccine, how long the vaccine is effective is also an important factor, as health officials seek to fight the pandemic.
“What we are going to do is hope that when we vaccinate people, the vaccine will provide protection that is at least long enough for a full seasonal cycle,” Fauci said Tuesday while speaking at an event at Georgetown University. “Hopefully much more, but if it isn’t, there is always an opportunity to give someone a boost.”
It is unclear how long the drug developed by Moderna will continue to be effective in test subjects, but the company said the subjects will continue to be monitored for one year after receiving the two doses.
“[Moderna}expectstoachieveasharedobjectiveofwhichtheparticipantsareintheCOVEstudyarerepresentativesofthecommunitieswiththehighestriskforCOVID-19andourdiversesociety”ischosenbythecommons[Moderna}esperalograrunobjetivocompartidodequelosparticipantesenelestudioCOVEseanrepresentativosdelascomunidadesconmayorriesgoparaCOVID-19ynuestrasociedaddiversa”seleeenelcomunicadodelacompañía[Moderna}hopestoachieveasharedgoalthattheparticipantsintheCOVEstudyarerepresentativeofthecommunitiesathighestriskforCOVID-19andourdiversesociety”thestatementfromthecompanyread
According to the New York Times, four other drugs entered Phase 3.
If the drug proves to be effective, Moderna said the company could make between 500 million and 1 billion doses a year starting in 2021, reaffirming that even if an effective vaccine is developed, it could take months before it is available to the public. .
