An “explosion” of new technologies is allowing researchers to accelerate efforts to develop a safe and effective coronavirus vaccine – or multiple vaccines for different patients. Which will prove best one is anybody’s guess.
“I’d like to firmly come down on, ‘Beats me,’ ” Dr. Paul Offit, a professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania and the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said when asked which of the 175 vaccines now under development are most likely to succeed. The new SARS-CoV-2 virus has not behaved as expected.
“I am no longer making guesses about this virus,” Offit said,
And while there may be rapid progress toward a vaccine before the election, Offit said that any “October Surprise” announcement of a successful vaccine before the November election should be viewed with skepticism, he told National Press Foundation fellows.
Offit and Dr. Leonard Friedland, vice president and director of scientific affairs and public health at GlaxoSmithKline’s vaccines division, agreed that the powerful technologies being deployed and the range of vaccines now in development suggest that any of them could prove successful.
“I hope they all work,” Friedland said. “We need multiple, multiple winners here. We need vaccines for 7 billion people on this planet. No one manufacturer is going to be able to scale up to make enough doses for 7 billion people.”
Offit and Friedland also said the nation needs to be on guard against a rush to vaccine judgment. That’s something that could be in play if people try to truncate normal safety and efficacy tests – the phase 3 trials of a vaccine that typically involve 30,000 people and take many months to complete. Even patients who get the vaccine will be advised to try to avoid infection through wearing masks and social distancing, and their outcomes will be compared with people who received a placebo.
“I think it’s extremely unlikely that we would have clear evidence from phase 3 studies of efficacy by the end of October, beginning of November,” said Offit, who sits on the Food and Drug Administration’s vaccines advisory committee. “Nonetheless, President Trump has said that he expects fully that we would have a vaccine by Election Day.”
That would only be possible if the administration were to cut off testing before deploying a vaccine – and that would be a mistake, he said.
“You want to make sure that we have clear efficacy data before we put this vaccine out there, because there is a fragile vaccine confidence in this country,” Offit said.
Only after phase 3 trials are completed can researchers say with confidence a vaccine is effective and without significant side effects. Once a drug or vaccine hits the market, health officials still need to watch out for the rare side effects that only emerge when it has been given to hundreds of thousands or millions of people.
Offit cited a famous statement from vaccine pioneer Maurice Hilleman: “I never breathe a sigh of relief until the first 3 million doses are out there.”
How will those doses be developed? Friedland said there is now “an explosion of new technology” that is allowing vaccines to be manufactured in different ways.
“There’s never been more money or more interest or more ideas on how to make a vaccine,” Offit said. More than 100 companies across the globe are working on it, and more than 120 applications have been submitted to the FDA, starting the regulatory oversight process. Traditional attenuated vaccines, used against measles, and inactivated ones, used to create the annual flu shot, have been joined by newer generation vaccines that inject strands of DNA or RNA into cells to prompt the body to develop antibodies. By attaching themselves to the distinctive spike proteins on the surface of the SARS-CoV-2 virus, the antibodies prevent infection. (For a good overview of the vaccine development process, see the COVID-19 Prevention Network.)
This program is funded by GlaxoSmithKline LLC. NPF is solely responsible for the content.