Sanofi executives said Monday that the Covid-19 vaccine that they were developing with GlaxoSmithKline could be the “universal booster” shot.
Results from a Phase 2 trial of the vaccine were promising enough for the two drugmakers to begin a 35,000-subject Phase 3 trial in the next few weeks, as Barron’s reported earlier.
Sanofi (ticker: SNY) and Glaxo (GSK) have been developing the vaccine for over a year, but the program suffered a setback in December when the companies announced that an early trial suggested it might not be effective enough in older adults.
Now, the companies are back with a new formulation of the vaccine, and they say that it might be most useful as a booster shot. On a press call held early Monday morning, Dr. Su-Peing Ng, Sanofi’s global head of medical for vaccines, said that levels of neutralizing antibodies were actually higher after a single dose of the vaccine in people who had previously been infected with the virus, than they were after two doses in people who had not been previously infected.
“We are achieving those levels even with the lowest formulations we tested,” Ng said.
That suggests that the vaccine may be particularly effective as a booster shot. Levels of neutralizing antibodies are increasingly seen as a predictor of the level of protection against Covid-19.
“The data we have seen in one single shot, at low dosage… makes us believe that we have the opportunity here to have a candidate that could be the so-called universal booster,” said Thomas Triomphe, head of Sanofi’s vaccine division, called Sanofi Pasteur, on the press call.
Triomphe said that, in addition to the large Phase 3 trial, the companies would also test whether the vaccine can be used as a booster in previously vaccinated people, regardless of which type of vaccine they initially received. He also noted that, unlike the messenger RNA-based vaccines, it has no extreme storage requirements.
Still, the Sanofi and Glaxo vaccine would face stiff competition in the Covid-19 booster vaccine market. The messenger RNA-based vaccines from Pfizer (PFE) and Moderna (MRNA) are also being tested as booster shots, and the companies already have plans to manufacture billions of doses and, in at least one case, contracts stretching out to 2023.
Executives have said that the messenger RNA-based vaccines could also be used as boosters regardless of what vaccine a person received as a first dose. What’s more, storage requirements for the mRNA-based vaccines are not as extreme as they were when the vaccines were first introduced.
Still, Triomphe suggested on the press call that Sanofi expected the market for Covid-19 boosters to be large.
“If you think about the fact that, as announced by manufacturers, there will be 10 billion doses available worldwide toward the end of the year, there is obviously the need for a booster shot,” he said.
Sanofi has been helping multiple competitors, including Pfizer , Moderna, and Johnson & Johnson (JNJ), to manufacture their Covid-19 vaccines. Triomphe said that those partnerships would not end immediately.
“We are not going to stop our three contracts tomorrow morning,” he said. “At some point, of course, once we have completed our contract with the three manufacturing partners, then we might want to reach a point where we might want to reshuffle production, but at this time, in the short to midterm, we don’t see a problem to do three contracts.”
In a note out early Monday, SVB Leerink analyst Geoffrey Porges said that it might be easier for Sanofi and Glaxo to enroll subjects in a booster trial than in the Phase 3 trial.
“If regulators are comfortable with enrollment mainly in Asia, Africa, and Latin America, then accumulating cases should not be a problem, but in the U.S. in particular, case rates are falling and the rate of accumulation of infection events could be much slower than recent pivotal trials,” Porges wrote. “On the other hand, using the SNY/GSK adjuvanted vaccine as a booster for previously immunized or infected individuals, based on boosting antibody titers against both Wuhan and variant strains of virus, could be a viable endpoint and a relatively easy trial to enroll.”
Shares of Sanofi were up 1.2% on Monday, while shares of Glaxo were up 1.3%. Shares of Moderna were down 1.9%, while shares of Pfizer’s partner BioNTech (BNTX) were up 0.7%.
Write to josh.nathan-kazis@barrons.com
May 17, 2021 at 09:59PM
https://ift.tt/3v834xD
Sanofi Executives Say Covid Vaccine Could Be 'Universal Booster' - Barron's
https://ift.tt/2DVP6sH
No comments:
Post a Comment