vaccine to get to everyone that needs it, and the vaccine will not be fully protective against inf

Author : torunlota

Publish Date : 2021-01-09 14:59:22

vaccine to get to everyone that needs it, and the vaccine will not be fully protective against inf

It will continue to be important for everyone to wear masks in public or around other people until large enough numbers of people have gotten the vaccine or the disease has stopped spreading through communities. It’s impossible to tell by looking at someone whether they’ve been vaccinated, so it would be impossible to effectively enforce mask mandates if only unvaccinated people were required to wear masks. (There aren’t plans to issue bracelets like those seen in the movie Contagion or anything similar.) Further, no vaccine is 100% effective, and we don’t yet know if any of the vaccines prevent transmission, so it might be possible to catch or transmit the disease even if you have been vaccinated.

“People have to understand that this is not a magic wand,” said Peggy Hamburg, a former commissioner of the U.S. Food and Drug Administration. “Once the vaccine starts to go out to priority populations, that doesn’t mean that suddenly we can abandon all of the other activities that are so important in terms of reducing rates of infection and controlling spread. It’s going to take time for the vaccine to get to everyone that needs it, and the vaccine will not be fully protective against infection and disease. We are still going to need to do those things that work, including wearing masks and social distancing.”

It’s possible that the more people who get vaccines, the more restrictions can be gradually loosened for restaurants, group gatherings, and similar activities, but it’s not going to happen overnight. Plan to continue following the CDC’s and other health experts’ recommendations as much as you can. Perhaps we can leave our masks at home by late 2021, but it’s impossible to say for now.

Q: How does the development and approval process of a Covid-19 vaccine compare to other vaccines in terms of the regulatory process?

Vaccines typically go through a lengthy FDA approval process that requires copious amounts of completed phase 3 trial data and can take many months. However, during a public emergency, the FDA can issue an Emergency Use Authorization (EUA) to allow use of an unapproved vaccine while trials are ongoing as long as the vaccine meets certain criteria (including the benefits outweighing the risks) and no alternatives exist. The FDA laid out the criteria for Covid-19 vaccines in October, including an efficacy of at least 50% and safety data for at least two months after complete vaccination.

EUAs have existed since the 1930s, but it wasn’t until 2004, following the 9/11 attacks and concerns about bioterrorism, that vaccines could receive them. Using EUAs for Covid-19 vaccines has critics, but the FDA still requires safety and effectiveness data from tens of thousands of trial participants before granting an EUA. Most importantly, the FDA still requires the VRBPAC — composed of independent experts who are not FDA employees — to review the vaccine data before deciding on an EUA.

Q: How has this vaccine been developed so quickly compared to past vaccines?

One of the biggest questions many people have is whether pharmaceutical companies or the FDA have cut corners in developing these vaccines so quickly. The name “Operation Warp Speed doesn’t necessarily engender this comfort and ease with the process,” said Michele Andrasik, PhD, director of social and behavioral sciences and community engagement at the Covid-19 Prevention Network at the Fred Hutchinson Cancer Research Center. “It’s been really important to tease apart which processes are being sped up.”

Indeed, this vaccine has been developed faster than any other in human history, Omer said. But that doesn’t mean corners were cut. “There have been attempts to interfere in Warp Speed, but at the core of it, the integrity of the vaccine process has been preserved,” he said. “It has been expedited by finding efficiencies in the process.”

There are two bottlenecks in prior vaccine development that Covid-19 trials cruised through.

“One of the reasons we’ve been able to move so quickly is the incredible financial investment,” said Devon Greyson, PhD, an assistant professor of health communication at the University of Massachusetts, Amherst. “Things usually take longer because we wait and see before taking the next step.”

The federal government invested nearly $10 billion in Operation Warp Speed. That enabled researchers, once they had enough data to know the vaccine was safe and induced an immune response, to move to phase 3 trials before phases 1 and 2 had even ended. It also allowed them to run combined phase 1/2 or phase 2/3 trials instead of each separately. “That doesn’t change the amount or length of follow-up we have,” Greyson said. “It just means that we were collecting things at the same time that we would have collected one after another, for financial reasons.”

Though this has long been common in cancer drug trials, it occurs less frequently in vaccine trials, which don’t usually have the urgency of cancer trials. Abundant funding also enabled researchers to enroll huge numbers of people in the phase 3 trials, which allows them to learn faster how effective the vaccine is.

The bigger trial-related holdup is usually waiting for enough infections to occur during phase 3 to learn how effective the vaccine is. The rarer a disease is, the longer it takes for enough people to become sick in both the placebo and vaccine arms. But Covid-19 cases shot up this summer and are especially exploding right now. In a sadly ironic twist, the huge numbers of new infections are “good” for a vaccine trial because it takes less time for enough trial participants to get sick and see how well the vaccine works.

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