CHICAGO, January 28 (Reuters) – Following the development and launch of COVID-19 vaccines at record speeds, drug manufacturers are already facing rapidly evolving variants of coronavirus that could make them ineffective, a challenge that will require months of research and massive investment funding, according to disease experts.
The directors of Moderna Inc and Pfizer Inc and the partner BioNTech SE are analyzing new versions of their vaccines to respond to the most worrying variants identified so far. This is just some of the work needed to stay ahead of the virus, nearly a dozen experts told Reuters.
A global surveillance network needs to be built to assess emerging options. Scientists need to determine what level of antibodies will be needed to protect people from COVID-19 and determine when vaccines need to be modified. Regulators also need to provide what is needed to demonstrate that up-to-date vaccines are still safe and effective.
“At this time, there is no evidence that these variants have changed the equation in terms of vaccine protection,” said Dr. Michael Osterholm, an infectious disease expert at the University of Minnesota. “But we have to be prepared for that.”
Johnson & Johnson told Reuters that the variant first identified in South Africa had attracted attention and would change its vaccine accordingly, if necessary. Pfizer said it could produce a new vaccine relatively quickly, but a top executive of the vaccine said it was making additional challenges.
The urgency of this effort is clear.
Moderna said on Monday that laboratory studies showed that antibodies produced in response to her vaccine were six times less effective at neutralizing a laboratory-created version of a South African variant than previous versions of the virus.
A study launched on Wednesday before the peer review found that the South African variant reduced neutralizing antibodies 8.6 times for the Moderna vaccine and 6.5 times for the Pfizer / BioNTech vaccine, although a separate study supported by Pfizer, released on Wednesday , suggests that his vaccine may be more resistant. Moderna said this week that it is starting work on a potential booster fire.
IT COULD TAKE MONDAY
It is not yet known how much protection may decrease before a COVID-19 vaccine is modified. With the flu, an eight-fold decrease in vaccine-induced antibody protection means time to update. This does not necessarily apply to this coronavirus.
“The problem is that we don’t know what the cutoff point is for coronavirus,” said Dr. John Mascola, director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), whose scientists contributed to the development of the vaccine. Modern.
Mascola said that both studies testing the Moderna vaccine against the South African variant are in “the same stadium”. Antibody protection may be high enough in the vaccine to be effective, he said.
NIAID scientists are analyzing data from the late Modern study to see what level of neutralizing antibodies are needed for protection. They compare people who have been vaccinated but got sick anyway with vaccinated people who have stayed healthy.
It could take two months to complete the work, Mascola said. They hope to produce a benchmark for the minimum level of vaccine-induced antibodies needed to protect against COVID-19.
A global surveillance network is also needed to identify new worrying variants as they emerge, similar to those used to track rapidly moving influenza viruses. That could cost tens to hundreds of millions of dollars in the United States alone.
Richard Webby, an influenza surveillance expert at St. Louis Children’s Research Hospital. Jude said the United States could probably build a system to identify the options fairly quickly. Developing the ability to determine whether to avoid current vaccines will take longer.
The United States is currently conducting genetic sequencing to look for changes in the virus in only 0.3% of positive coronavirus tests. This is fading compared to 10% in the UK, which first discovered a major mutation in the virus that increases transmission by at least 50%. Experts said countries should sequence at least 5% of positive cases to detect significant changes in the virus.
The companies are waiting for the US Food and Drug Administration to provide what tests will be needed for the modified vaccines, said Phil Dormitzer, one of the top scientists in the Pfizer viral vaccine. With flu vaccines, companies can make changes without new studies. “But that’s 50 years after he did it,” he said.
Peter Marks, who oversees the FDA’s vaccine approval process, said small studies may be needed at first to test updated vaccines in about 400 participants. Even that could add months to the process.
Norman Baylor, executive director of Biologics Consulting and former FDA vaccine official, said the agency will set the regulatory path. But public health agencies such as the US Centers for Disease Control and Prevention and the World Health Organization would decide when vaccines should be updated, as in the case of influenza.
Changing the Pfizer vaccine would require “very little change,” Dormitzer said.
Like Moderna, it uses RNA messenger (mRNA) technology, which is based on synthetic genes that can be generated and manufactured in a matter of weeks.
He estimates that the company could make a prototype version in a week or so and it will take another two months to expand and update its laboratory tests.
J&J, which is expected to release test data on the late-stage vaccine in a few days, has laid the groundwork for addressing the virus’s disturbing changes, scientific director Paul Stoffels told Reuters. His process included sites in South Africa, which should provide the company with information about this option.
If a change is needed, Stoffels said J&J would likely add a second strain to the existing vaccine.
“We look at this very carefully,” he said.
Reporting by Julie Steenhuysen in Chicago and Michael Erman in New York; Edited by Caroline Humer and Bill Berkrot