CHICAGO, Jan. 28 (Reuters) – After developing and launching the COVID-19 vaccines at record speed, drug makers are already facing rapidly evolving coronavirus variants that could render them ineffective, a challenge that will require months of research and a high financial investment cost, according to disease experts.
Executives at Moderna Inc and Pfizer Inc and partner BioNTech SE are considering new versions of their vaccines to respond to the most worrying variants identified so far. This is only part of the work needed to stay ahead of the virus, almost a dozen experts told Reuters.
A global surveillance network to assess emerging variants must be built. Scientists need to establish what level of antibodies will be needed to protect people from COVID-19 and determine when vaccines need to be changed. And regulators must convey what is needed to demonstrate that updated vaccines are still safe and effective.
“At this point, there is no evidence that these variants have changed the equation in terms of protection against the vaccine,” said Dr. Michael Osterholm, an infectious disease specialist at the University of Minnesota. “But we have to be prepared for that.”
Johnson & Johnson told Reuters that the worrying variant first identified in South Africa caught his eye and will adjust his vaccine as needed. Pfizer said it could produce a new vaccine relatively quickly, but a senior executive said that making it presents additional challenges.
The urgency of this effort is clear.
Moderna said on Monday that laboratory studies have shown that antibodies produced in response to its vaccine are six times less effective in neutralizing a laboratory-created version of a South African variant than previous versions of the virus.
A study released on Wednesday before the peer review found that the South African variant reduced neutralizing antibodies 8.6 times for the Modern vaccine and 6.5 times for the Pfizer / BioNTech vaccine, although a separate study supported by Pfizer released on Wednesday suggest that your vaccine may be more resistant. Moderna said this week that it is starting to work on a potential firing shot.
COULD TAKE MONTHS
It is not yet known how far protection may fall before a COVID-19 vaccine needs to be changed. With the flu, an eight-fold drop 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 for coronavirus is,” said Dr. John Mascola, director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), whose scientists helped develop the disease. Moderna vaccine.
Mascola said that the two studies that test the Modern vaccine against the South African variant are approximately “on the same level”. It may be that the protection of the antibody is high enough with the vaccine that it is still effective, he said.
NIAID scientists are analyzing data from the last stage of the Moderna assay to see what level of neutralizing antibodies is needed for protection. They are comparing individuals who were vaccinated but fell ill anyway, with vaccinated people who remained healthy.
It may take two months to complete this work, said Mascola. 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 variants of concern as they arise, similar to the one used to track rapidly changing flu viruses. This can cost tens to hundreds of millions of dollars in the United States alone.
Richard Webby, an influenza surveillance expert at St. Jude Children’s Research Hospital, said the United States could probably build a system to identify variants quickly. Developing the ability to determine whether they 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 pales compared to 10% in the UK, which was the first to discover 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 United States Food and Drug Administration to disclose which tests will be needed for altered vaccines, said Phil Dormitzer, one of Pfizer’s leading scientists on viral vaccines. With flu vaccines, companies can make changes without further testing. “But this after doing this for 50 years,” he said.
Peter Marks, who oversees the FDA’s vaccine approval process, said that small trials initially testing updated vaccines in about 400 participants may be necessary. Even that could add months to the process.
Norman Baylor, chief executive of Biologics Consulting and a former FDA vaccine official, said the agency will chart the regulatory path. But public health agencies, like the Centers for Disease Control and Prevention in the United States 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,” said Dormitzer.
Like Moderna, it uses messenger RNA (mRNA) technology, which is based on synthetic genes that can be generated and manufactured in weeks.
He estimates that the company could make a version of the prototype in about a week and take another two months to expand and update its laboratory tests.
J&J, which is due to release data on final testing of its vaccine within a few days, has laid the groundwork for dealing with worrying virus changes, scientific director Paul Stoffels told Reuters. His test included sites in South Africa, which should give the company an insight into this variant.
If a change is needed, Stoffels said J&J would likely add a second strain to its existing vaccine.
“We are looking at this very carefully,” he said.
Reporting by Julie Steenhuysen in Chicago and Michael Erman in New York; Editing by Caroline Humer and Bill Berkrot