5 takeaways with Dr. Paul Offit:
➀ The first vaccine candidates out of the gate look good – but even-better ones might emerge. “The first vaccines are often not the last best vaccines,” said renowned vaccine researcher Dr. Paul Offit. The news that preliminary results found some vaccine candidates to be 90% effective is encouraging. But 175 vaccines are now under development, and history is filled with examples of follow-up vaccines demonstrating superiority. The first Haemophilus influenza B vaccine was replaced by a better vaccine two years later, he said. The shingles vaccine in 2011 was replaced by a better shingles vaccine in 2017. The first measles vaccine in 1963 was replaced by a much better measles vaccine in 1968. The first rubella vaccine in 1969 was replaced by a safer rubella vaccine 10 years later.
➁ Although the vaccine approval process has been accelerated, it is no less rigorous. Vaccines often take years to research and develop. Offit himself was involved in one 26-year effort for approval of a rotavirus vaccine. Asked if any corners were being cut in the coronavirus approval process, Offit said, “I think the real answer is no. We just speeded up the process … because the federal government was willing to take the risk out of it for pharmaceutical companies.” Bloomberg Businessweek calculated the total federal commitment at $18 billion.
➂ Doctors will be on the lookout for side effects, but the approval process should catch most of them. The accelerated process leaves less time to spot the kind of adverse events that emerge when any new drug or vaccine is administered to millions of patients. That said, Offit is comfortable with the timetable. “If you look at the serious side effects associated with vaccines, to what extent are you going to pick them up within two months?” he asked. Judging from the past two centuries of vaccines history, Offit said, “I think you’ll pick most of them up.”
➃ Vaccine hesitancy remains a problem, although it’s easing somewhat. Polls in mid-2020 found only half of American adults were willing to receive a coronavirus vaccine. By November 2020, that had inched up in a Gallup poll to 58% – better, but still insufficient to trigger herd immunity. There remain large pockets of resistance to taking a vaccine.
➄ There are multiple safeguards to prevent politics from interfering with vaccine approvals. In Australia, planning is done at the state or regional level. In the U.S., it’s at the city or town level. “And that changes the way the development happens,” said Brian O’Looney, an architect with Torti Gallas and Partners, which works in cities around the world. Suburban developments 25 miles outside of a city might have the same population density as in that city, with apartment towers instead of single-family homes.
Offit is on the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, which, as its name suggests, helps the FDA review applications from drugmakers seeking vaccine approval. The U.S. Centers for Disease Control and Prevention also has an Advisory Committee on Immunization Practices, which helps set standards once vaccines are approved. Many feared that President Donald Trump would interfere with the approval process and rush through an inadequately tested vaccine. But Offit said the system can be trusted – including the FDA advisory committee he sits on. “We’ll make a recommendation based on whether we think we would take these vaccines ourselves or give them to our family before we recommend them for other people’s families. … I can see where the distrust comes from, but I think it’s time to put that aside. I really do. Everything that’s in place now is what should be in place.”
This program was funded by GlaxoSmithKline LLC. NPF is solely responsible for the content.
