CHICAGO (Reuters) – After developing and rolling out COVID-19 vaccines at the fastest pace, drug dealers are already facing changes in the fast-growing and potentially chronic coronavirus. being ineffective, a challenge that requires months of scrutiny and major financial investment, according to disease experts.
Officials from Moderna Inc and Pfizer Inc and partner BioNTech SE are considering new versions of their vaccines to respond to the most worrying variables identified to date. That’s just one piece of work needed to stay ahead of the virus, nearly a dozen experts told Reuters.
A global monitoring network needs to be built to evaluate different changes. Scientists need to find out what level of antibodies are needed to protect people from COVID-19 and find out when vaccines need to be changed. And regulators need what is needed to show that up-to-date vaccines remain safe and effective.
“At this stage, there is no evidence that these variables have altered the vaccine protection equation,” said Dr. Michael Osterholm, an infectious disease specialist at the University of Minnesota. “But we have to be ready for that.”
Johnson & Johnson told Reuters that the worrying variant first identified in South Africa has caught attention and they will drop the vaccine accordingly if necessary. Pfizer said it could make a new vaccine relatively quickly, but a senior vaccination officer said manufacturing presents additional challenges.
The urgency of this effort is clear.
Moderna said Monday that laboratory studies showed that antibodies made in response to the vaccine were six times as effective in neutralizing a laboratory-created version of a South African variant. previous versions of the virus.
A study released Wednesday ahead of a peer review found that the South African variant reduced neutralizing antibodies by 8.6-fold for the Moderna vaccine and by 6.5-fold for the Pfizer image / BioNTech, although a separate study backed by Pfizer released Wednesday suggests that getting its vaccine could be tougher. Moderna said this week that they are beginning work on a potential escalation view.
DOES NOT INCLUDE MIS
It is not yet known how long protection may be bypassed before the COVID-19 vaccine needs to be modified. With flu, an eight-fold drop in vaccine-induced antibody immunity means time for renewal. That does not necessarily apply to this coronavirus.
“The problem is we don’t know what the cut-off point is for coronavirus,” said Dr. John Mascola, director of the Vaccine Research Center at the National Institute of Allergies and Infectious Diseases (NIAID), which helped the scientists Moderna vaccine development.
Mascola said the two studies testing the Moderna vaccine against the South African variant are essentially in the same “ballpark.” It may be that antibody protection is high enough from the vaccine that it will still be effective, he said.
NIAID scientists are analyzing data from the Moderna end-of-life trial to see how much neutral antibodies are necessary for protection. They compare people who received the vaccine but became ill at least with those who received the vaccine who remained healthy.
It could take two months to complete this work, Mascola said. They hope to set 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 difficult new changes as they unfold, similar to one used to detect rapid flu viruses. That could cost tens to hundreds of millions of dollars in the United States alone.
Richard Webby, a flu study expert from St. Jude Children’s Research Hospital, said the United States could build a system to quickly identify changes. It will take more time to develop the ability to find out if they are avoiding routine vaccines.
The United States is currently doing genetic sequences to look for changes in the virus in just 0.3% of advanced coronavirus tests. That compares with 10% in the UK, which initially detected a large mutation in the virus that increases transmission by at least 50%. Experts said that countries should order at least 5% of advanced cases to detect major changes in the virus.
Companies are waiting for the U.S. Food and Drug Administration to reiterate the tests required for modified vaccines, said Phil Dormitzer, one of Pfizer ‘s leading viral vaccine scientists. With flu vaccines, companies can make changes without new tests. “But that has been done for 50 years,” he said.
Peter Marks, who oversees the FDA’s vaccine approval process, has said that small trials testing up-to-date vaccines in around 400 participants may be required initially. That could even add months to the process.
Norman Baylor, chief executive officer of Biologics Consulting and former vaccine officer at FDA, said the agency will outline the regulatory path. But public health bodies like the U.S. Centers for Disease Control and Prevention and the World Health Organization would decide when vaccines should be renewed, as is the case with the flu.
Pfizer’s vaccine modification requires “very little change,” Dormitzer said.
Like Moderna’s, it uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and produced in weeks.
He believes the company could make a prototype version in a week or so, and take another two months to update and refresh their lab tests.
J&J, which is expected to release late-stage test data on its vaccine within days, has laid the groundwork to deal with troublesome viral changes, the Chief Executive said. Scientific Paul Stoffels to Reuters. His experiment covered sites in South Africa, which should give the company an insight into that difference.
If a change is needed, Stoffels said J&J would be likely to add a second strain to the existing vaccine.
“We are looking at this with a lot of attention,” he said.
Reporting by Julie Steenhuysen in Chicago and Michael Erman in New York; Edited by Caroline Humer and Bill Berkrot