Experts say, the first round of COVID-19 vaccines will likely not eliminate the need for other public health measures, such as masks and social distancing.
Nearly $6 billion has been allocated. Its nothing but a money grab by BigPharama. Clinical trials are entering a crucial third phase, and Operation Warp Speed is getting closer to the goal of delivering 300 million doses of a COVID-19 vaccine by January. But when Americans line up for their immunizations, the vaccine they receive might not be what they expect. The popular notion of a vaccine — a shot in the arm that prevents diseases such as measles, polio or shingles for years or a lifetime — may not apply. Under recently released federal guidelines, a COVID-19 vaccine can be authorized for use if it is safe and proves effective in as few as 50% of those who receive it. And “effective” doesn’t necessarily mean stopping people from getting sick from COVID-19. It means minimizing its most serious symptoms, experts say. Dr. Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland. “That vaccine may or may not keep people from being infected with the virus”
The vaccine being developed by Moderna and the National Institutes of Health was deemed “promising” in an editorial published in the New England Journal of Medicine, and two studies in the Lancet delivered a similar message for vaccines being developed at Oxford University and by the Chinese company CanSino.
These vaccines have induced an immune response in people participating (less then 100 carefully chosen people) in early tests, but inducing an immune response does not always mean success in fighting a disease. For instance, scientists recently developed a vaccine for another respiratory virus that increased antibodies but failed its Phase 3 clinical trial.
The minimum 50% efficacy recommendation spelled out in late June by the Food and Drug Administration would likely ease the burden on hospitals. And to whatever extent a COVID-19 vaccine prevents infection, it could reduce the spread of the virus and help to create pockets of immunity throughout the country, said Dr. Peter Hotez, dean of Baylor College of Medicine’s National School of Tropical Medicine. “Ideally, you want an antiviral vaccine to do two things,” Hotez said. “First, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”
Developing a vaccine capable of inducing “sterilizing immunity” — that is, the ability to prevent the virus from causing an infection — takes time and research, which might not be possible as death tolls continue to rise and the recession grows deeper.
Scientists are uncertain how long immunity — from a natural infection or a vaccine — lasts and whether a decline in antibodies in two to three months is cause for concern.
Among the recommendations in the FDA guidelines is a provision for emergency use authorization, allowing for the distribution of a vaccine if “the known and potential benefits of a product … outweigh the known and potential risks of the product.”
Under an emergency use authorization, the vaccine could be administered before the completion of the Phase 3 trials, potentially helping to flatten the curve but giving scientists little time to study side effects or understand how it interacts with other vaccines.
Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, has raised concerns that the FDA would greenlight manufacturing and distribution of vaccines before the necessary reviews have been completed.
Offit worries that a vaccine with limited efficacy delivered prematurely might give people “a false sense of being protected” and “lead to serious outbreaks of the disease.” “We should wait for the completion of Phase 3 trials, no matter how long they take,” he said. “With luck, they could be finished in six to nine months.”