The world will not get the Covid-19 pandemic under control without using booster shots for messenger RNA vaccines, one of the key figures involved in the development of the Pfizer and BioNTech vaccine said Tuesday.
Ugur Sahin, co-founder and CEO of BioNTech, insisted booster shots are going to be necessary, despite caution from some experts.
“At the end of the day it really matters that we get this pandemic under control. And we will not get it under control without boosting. That’s my strong opinion,” Sahin said.
Sahin made the remarks during a panel session at the STAT Breakthrough Science Summit, where he was joined by Kathrin Jansen, head of vaccine research and development at Pfizer. Jansen said Pfizer’s decision to develop and test Covid-19 vaccine booster shots is being driven by data. “The booster situation is not about making money,” she said.
A large study of booster shots developed by the company will read out soon, Jansen added.
Pfizer triggered controversy last week — National Institutes of Health Director Francis Collins referred to it as “a dust-up’’ — when the company issued a statement suggesting booster shots will be needed to keep protection against the virus at high levels. The statement referred to data that have not yet been published.
The director-general of the World Health Organization, Tedros Adhanom Ghebreyesus, criticized the notion of giving residents of wealthy countries a third shot before health workers and older adults in many countries get their first Covid-19 jab. And Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said people are “jumping the gun” if they think booster shots are on the verge of being authorized.
Neither Jansen nor Sahin elaborated on the data that the companies say support their view that booster shots will be needed. Sahin said there is evidence of a slight decline in antibody levels in people four to six months after they were vaccinated. To date, there hasn’t been an indication that people who have been vaccinated are developing severe Covid infections, but Sahin said “we expect that we will also see some drop of protection against severe disease … a small drop.”
“Therefore our position is … that a booster shot could be helpful to restore immunity, full immunity, and thereby ensure we have a winter season which is not complicated by true infections in vaccinated people,” he said.
There is currently no sign that people in the United States who were vaccinated early in the country’s vaccine rollout are seeing their protection wane, Jay Butler, the deputy director for infectious diseases at the Centers for Disease Protection and Control, said earlier Tuesday.
“We’re not seeing evidence at this point in time that waning immunity is occurring among people who were vaccinated back last December or January and that they are at higher risk of breakthrough infections,” Butler said during a media briefing organized by the Infectious Diseases Society of America.
Jansen said part of the goal of the companies’ research on boosters — which includes studying the impact of giving people a third dose of vaccine that protects against one of the variants of concern — is to create a regulatory pathway for updating Covid vaccines if that becomes necessary.
Though she did not mention it, there is a regulatory pathway for updating influenza vaccines. Rather than requiring manufacturers to run large-scale clinical trials every time flu vaccines are tweaked to try to keep up with ever-changing viruses, the Food and Drug Administration allows manufacturers to update the viral targets through an expedited process referred to as a strain change. As long as the production process remains unaltered, manufacturers can swap out an old version of H1N1 flu, for instance, and include a strain that is currently causing disease.
In other remarks, Jansen voiced concern about Covid-19 vaccine uptake, saying the misinformation about vaccines that is prevalent on the internet is impeding progress toward getting enough people vaccinated to control the virus.
“I think it’s a huge issue for us, because we always will be behind the virus,” she said. “We cannot get ahead of it if large fractions of the population refuse to be vaccinated.”
Allowing the virus to continue to spread unchecked will give rise to additional variants, some which may be able to evade the protection of vaccines, Sahin and Jansen warned.
“As long as we allow the virus to have a breeding ground in unvaccinated people, we will force the virus to adapt, to mutate, to change, and it will be a disaster because we will not be able to get ahead of it,” Jansen said.
The two also talked about the challenges of developing a new vaccine in under a year. “In every vaccine development program you have enormous challenges. And the difference is that those challenges are over 10 years. Here we have the same challenges over nine months,” Jansen said with a laugh.
Asked what lies ahead for mRNA technology, after its enormously successful testing in the Covid pandemic, she said Pfizer wants to turn its focus to flu.
“We have aspirations to come up with a truly game-changing influenza vaccine that could actually far surpass the efficacy, potentially, of current vaccines,” she said. Existing flu vaccines aren’t adequately effective in elderly people, who are at high risk of developing severe illness if they contract the flu. But the Covid mRNA vaccines are highly effective in the elderly, she noted, which suggests the platform could be very useful for flu shots.
“It opens up a lot of possibilities in the infectious diseases space,” Jansen said.