SARS-CoV-2, the coronavirus responsible for COVID-19, has infected many millions of people both in the United States and around the world. The death toll is horrifying, with more than a quarter of a million people in the US alone. With infections soaring as we head into winter, the news that a couple of vaccines against COVID-19 appear to be effective is especially welcome.
Pharmaceutical firms around the world are working hard to develop vaccines against COVID-19. In the US, those that are farthest along are based on a new technology using messenger RNA (mRNA). Both Pfizer and Moderna are using this approach, and both have recently announced effectiveness rates approaching 95 percent. So far, what the world has seen are press releases. However, when the companies apply for approval or emergency use authorization, the FDA will examine the data carefully.
To determine a vaccine’s effectiveness, some volunteers in the trial must get the immunization while others get a placebo. Neither the participants nor the researchers can know who has received vaccine and who got placebo. That is the only way to be able to tell if the vaccine actually works.
For the vaccines currently under development, the companies made a special effort to recruit a diverse group of volunteers. They wanted participants of various ages, genders and ethnic background so they could make sure the shot will be safe and effective for everyone. Moreover, they wanted to make sure to test it in tens of thousands of people. That way, they could be reasonably sure to detect common side effects. Even some uncommon reactions will show up if you give a shot to 20,000 individuals.
Once data on these vaccines have been closely examined by the FDA and its advisory committee, the Centers for Disease Control and Prevention will also take a look. If they are given the green light, the firms face the hardest part: producing and distributing the shots. Both of these new vaccines need to be transported and stored at cold temperatures. However, the Pfizer vaccine has some extreme requirements that are likely to pose logistical challenges.
Public policy suggests that people at highest risk should be the first to get their shots. That would definitely include health care workers and first responders. It might also include essential workers and people with health conditions that put them at risk. It may take some time before everyone can be protected. In the meantime, we will all have to stay vigilant with distance, facial coverings, hand hygiene and avoiding gathering with others indoors. Our guest, Dr. Paul Offit, is one of the country’s leading experts on vaccines. He serves on the advisory committee for Vaccines and Related Biological Products at the FDA. He shares his knowledge, his concerns about vaccine-related misinformation and his vision of how we can bring this pandemic to a close.
Paul A. Offit, MD is the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia as well as the Maurice R. Hilleman Professor of Vaccinology and a Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania.