Hopeful news about a Covid-19 vaccine developed by researchers from the US government and Moderna Inc has created expectations – and markets – of the potential for a preventive measure against a global pandemic that has killed more than half a million people and increased everyday life.
Modern first announced its vaccine, with the support of the National Institute of Allergy and Infectious Diseases, which received an immune response in 45 adults in May.
On Tuesday, it published a more complete look at the data in a report in the New England Journal of Medicine.
But experts warned against rising expectations for the Moderna vaccine, one of many being worked on around the world, as it is still in its early stages of development.
The report was “really no reason to celebrate,”
“These are small studies,” Hotez added. “That’s why you have to do the big Phase 3 clinical trials on 10,000 to 30,000 patients,” he said.
The news comes as falls grow across America’s Sun Belt, a region that stretches across Southern California to Florida, and researchers not involved in the research noted challenges ahead.
Florida has crossed an ominous threshold with more than 300,000 cases of Covid-19. Oklahoma Republican Gov. Kevin Stitt said he had tested positive for Covid-19, the first known case of a U.S. governor.
And the United States’ foremost infectious disease expert, Dr. Anthony Fauci, made a clear call to the White House to stop “nonsense”, citing criticism of his efforts, in an interview with the Atlantic.
More than 150 laboratories worldwide are working to develop Covid-19 vaccines, most in the early stages. The mother’s vaccine is one of 23 in human studies, and a handful entered phase 3 in clinical trials.
Moderna is one of five pharmaceutical companies that have received billions from the US government in a vaccine development initiative called Operation Warp Speed. Later this month, Moderna and a handful of other laboratories will begin recruiting tens of thousands of volunteers to take the vaccine.
Future studies must balance safety and efficiency. In other words, how much dose of the vaccine is necessary to make it effective while minimizing unpleasant and potentially harmful side effects?
“The safety and immunogenicity data in this preliminary report are promising, and they support the continued development of this vaccine,” said Dr. Penny M Heaton, CEO of the Bill and Melinda Gates Foundation Medical Research Institute, in an editorial accompanying the Moderne study. “But we must remember the complexity of vaccine development and the work that still needs to be done before Covid-19 vaccines are widely available.”
Notably, researchers from Moderna have abandoned a higher dose of the vaccine because it did not appear to provide a better immune response and gave worse side effects, including headaches, chills, fever and fatigue.
At the same time, researchers have to contend with Covid-19 antibody tests that can be unreliable. It is also unclear how long an immune response can last. One year? Six months? The modern study reported the results after 57 days, although researchers will follow the participants for one year.
In addition, older people who are most exposed to Covid-19 may face special challenges. Older people may need more of the vaccine because their immune systems are generally less sensitive. The same phenomenon occurs in flu vaccines, Heaton wrote.
In light of so many unknowns, basic questions remain as to when and if a vaccine will be developed for Covid-19, and what it will look like once approved.
“Everyone has said, ‘We will have these vaccines this fall or by the end of 2020,’ and I keep saying, ‘No, we’ll need these Phase 3 studies,'” Hotez said. “We will not have the information until the third quarter of 2021, and even that would be a world speed record.”
The news has also renewed criticism of Operation Warp Speed and how to distribute an approved vaccine fairly in a world where taxpayers subsidized its development and demand will exceed supply many times over.
“We are now two months on Operation Warp Speed and people across the country still have no idea if the pharmaceutical company’s CEO Trump was responsible for it ensured some assurances regarding the availability and value of vaccines developed with taxpayer dollars,” said Eli Zupnick, spokesman for Patients Over Pharma, a group critical of pharmaceutical companies.