Ongoing trials yielded promising results so far in the development of a COVID-19 vaccine, two Bucknell University biology professors said, but they expressed caution about a potential fall rollout and warned against blending politics and science.
The Centers for Disease Control and Prevention advised public health agencies in late August that two vaccines were potentially on track for limited distribution by November for health care employees, other essential workers and residents of nursing facilities.
Manufacturing and delivery models are being developed simultaneously with the ongoing trials as pharmaceutical companies race to develop a safe and viable vaccine. The White House launched Operation Warp Speed and distributed billions of dollars, working with public agencies and private companies to produce and deliver 300 million doses of vaccines for widespread distribution by January 2021.
Professor Marie Pizzorno, who’s trained in molecular virology and taught courses on the history of microbiology, said the typical vaccine development process can take 10 to 15 years or more before approval is achieved. Safety is paramount since vaccines are given to healthy persons to prevent infections, she said.
A group of pharmaceutical firms developing COVID-19 vaccines pledged this week to uphold efficacy and safety standards. AstraZeneca halted its own late-stage clinical trial when one patient out of thousands suffered a severe adverse reaction to the vaccine prototype.
“Vaccines need to have few or short-lived side-effects to be considered safe by the general public,” Pizzorno said. “One of the ways that this vaccine development process has been supercharged is by completing some steps in parallel. So while the clinical trials are currently taking place, the manufacturing and delivery processes are being set up so that if/when a vaccine is approved, it can be quickly manufactured and distributed to the public.”
“While we shouldn't have the safety testing be short-changed, we can have those other aspects prepared ahead of time so the vaccine can be quickly made available after it is approved,” Pizzorno said.
The New York Times developed a Coronavirus Vaccine Tracker documenting recorded progress of the efforts in the U.S. and globally. According to the tracker, 38 vaccines are now in clinical trials on humans and at least another 93 preclinical vaccines are under active investigation in animals. The Times shows 9 vaccines are in large-scale Phase III trials where thousands of people are involved in testing, including Moderna and Pfizer progressing furthest in the United States.
Professor Ken Field and a fellow biology professor at Bucknell, DeeAnn Reeder, are actively studying the tolerance of bats towards coronaviruses. Field agreed with Pizzorno that at least one vaccine is on the cusp.
Field said previous research on candidate vaccines for other types of coronaviruses helped accelerate the process for a SARS-CoV2 vaccine, the novel virus that causes COVID-19.
“Most of the vaccines that are being tested are very similar to other, approved vaccines that are already known to be safe. Given the multitude of different approaches it is very likely that at least one, and probably more than one, will be successful,” Field said.
A potential fall rollout doesn’t seem likely, Field and Pizzorno agreed. Field said a vaccine’s effectiveness takes time to measure.
“We don't want a vaccine that can only provide weeks of protection. To be viable, the protection will have to last at least six months. Now we might decide after three months that things are looking promising enough to begin scaling up, but a vaccine won't be available until we know how long the protection lasts,” Field said.
The federal government will enroll vaccination providers who will receive vaccine and ancillary supplies at no cost, according to the CDC memo to public health agencies. U.S. Health and Human Services announced this week that pharmacists and pharmacy interns, with certain training, would be approved with other clinicians to administer COVID-19 vaccines to children between the ages of 3 and 18. The American Medical Association opposed the move, advocating for a traditional physician-led approach and saying the change interrupts comprehensive preventative care for patients.
The pandemic interrupted traditional vaccine schedules across the country as fewer children are receiving treatments this year, according to multiple sources. There’s also growing skepticism about the potential effect and intent of a vaccine, as easily evidenced on social media.
Dr. Rachel Levine, Pennsylvania’s health secretary, said earlier this month that public education would be paramount in convincing people about the safety and effectiveness of a vaccine. Pizzorno and Field agreed with that sentiment.
“If the public does not trust the process that produced or tested the vaccine then they will not want to receive the injections. If not enough people take the vaccine, then the percentage of people who are immune will not be high enough to protect the vulnerable members of the population,” Pizzorno said.
Pizzorno said it’s important to note that most of the vaccines currently being tested don’t contain the whole virus, “just small bits of the virus that will stimulate the immune system to react and protect against infection. There is no way for someone to actually get (COVID-19) from these vaccines.”
Putting political pressure on the Food and Drug Administration to approve a vaccine may undermine public trust, likening it to the hits the CDC endured during the pandemic, Field said. Dr. Francis Collins, the director of the National Institutes of Health, testified before the Senate on Wednesday, warning against politicizing the issue and saying he hoped “Americans will choose to take the information they need from scientists and not from politicians.”
“My main concern is that the political pressure might undermine the credibility of the safety of the vaccine. No one can know how long it will take to prove the vaccine is safe and effective and any politician who claims otherwise is not telling the truth,” Field said.