Last summer, before the startling trial results that showed that vaccines from Pfizer and Moderna offered extraordinary levels of protection against Covid-19, there was another vaccine that was expected to be key in fighting the pandemic.
That vaccine, under development by Sanofi and GlaxoSmithKline, two of the world’s largest vaccine makers before the pandemic, was based on a proven technology, unlike the other leading vaccine candidates.
The same day that the FDA authorized Pfizer ’s (ticker: PFE) Covid-19 vaccine, however, Sanofi (SNY) and Glaxo (GSK) announced a major delay in the development of their vaccine, saying an early trial suggested that it wasn’t effective enough in older adults.
Now, five months later, the vaccine is back — and this time, the companies say it might be most useful as a booster shot.
In a press release issued early Monday morning in Paris, the two companies said that a 722-subject Phase 2 study of an updated version of their vaccine elicited what it called “strong” levels of neutralizing antibodies after two doses across all age groups.
The joint statement was light on details. Sanofi and Glaxo plan to publish results of the trial in a peer-reviewed scientific journal.
The companies said that the neutralizing antibody levels observed in trial subjects were “comparable” to levels generated by a natural infection, and were higher in people under 59 years old.
While comparisons between trials are difficult, especially given the scant details provided by Sanofi and Glaxo, that may suggest that their vaccine elicits weaker antibody responses than the Pfizer and Moderna (MRNA) vaccines. A number of studies have found that antibody neutralizing activity is higher in people who received messenger RNA-based vaccines than those who had recovered from natural infections.
Asked about the neutralizing antibody levels seen in the Phase 2 study, a Sanofi spokesperson, Ashleigh Koss, said in a statement that the companies have confidence that their vaccine is promising and could help address the pandemic.
“Direct comparisons with data from competitors are not possible as study populations and immunological assays vary from study to study,” Koss wrote.
Sanofi and Glaxo say that their vaccine could be particularly useful as a booster shot. The companies said that trial participants who had previously been infected with the virus that causes Covid-19 had high neutralizing antibody levels after a single dose of their vaccine, suggesting that the vaccine may work well as a booster.
“Our Phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis,” said Thomas Triomphe, head of Sanofi’s vaccine division, called Sanofi Pasteur.
Sanofi and Glaxo will begin a Phase 3 study of the vaccine within weeks, in which they plan to enroll more than 35,000 participants. The Phase 3 study will test two versions of the vaccine, one designed to target the original strain of the virus, and one that targets the so-called South African variant. They will also run a parallel trial to test the vaccine as a booster shot.
The companies say they expect regulatory approval for the vaccine in the fourth quarter of the year.
What remains to be seen is whether the reemergence of the Sanofi and Glaxo vaccine will shake up the global Covid-19 vaccine market, which is increasingly dominated by Pfizer and Moderna.
Between them, Pfizer and Moderna aim to make six billion Covid-19 vaccine doses or more next year. Both companies are testing various booster strategies using their own vaccine, and both aim to begin selling booster doses later this year.
Though Wall Street analysts have been skeptical about the sales potential for the vaccines beyond 2022, they have begun raising their estimates in recent days, with one analyst at Morgan Stanley saying he now expects Pfizer to record $32 billion in vaccine revenue in 2022.
Sanofi and Glaxo have the advantage of being two of the world’s biggest vaccine makers. But that advantage may be dulled by the fourth quarter of this year, at which point Pfizer and Moderna will have been making Covid-19 vaccines at an unprecedented scale for more than a year.
Sanofi, in fact, has been part of that effort, helping manufacture both Pfizer and Moderna’s Covid-19 vaccines, among others.
Now, Sanofi, with Glaxo, is ready to move forward with its own product.
“We believe that this vaccine candidate can make a significant contribution to the ongoing fight against Covid-19 and will move to Phase 3 as soon as possible to meet our goal of making it available before the end of the year,” Glaxo’s Roger Connor, president of GSK Vaccines, said in a statement.
Write to josh.nathan-kazis@barrons.com
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May 17, 2021 at 12:30PM
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Sanofi and Glaxo Are Back With a Covid-19 Vaccine - Barron's
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