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COVID-19 vaccine could be ready for production in months if Phase 3 trial goes well

Northwest Herald

Friday, July 31, 2020  |  Article  |  By KELLI DUNCAN

Health (49)
Top expert at Northwestern says unprecedented speed of the process not worrisome

One of the world's top COVID-19 vaccine candidates could be ready for production and distribution in a matter of months if proven effective and safe in its Phase 3 clinical trial, according to a local specialist overseeing the trial at Northwestern Medicine Central DuPage Hospital.

Northwestern Medicine will begin its Phase 3 trial of a new COVID-19 vaccine candidate in mid-to-late August, infectious disease specialist Dr. Daniel P. Boyle said in an interview on Wednesday. The trial, which is being conducted at hospitals across the country as well as locally, should be finished in about eight weeks.

“It's so impressive how quickly these vaccine trials have gotten moving,” Boyle said. “We've been involved with some other trials with some of these potential therapeutic drugs for our patients who are infected and it's amazing how quickly they get these studies up and running.”

With the race for a viable vaccine candidate moving faster than ever before, a recent poll conducted by the Associated Press found that only about half of Americans said they would agree to get a COVID-19 vaccine if one were to come to market. Seven out of 10 of the respondents who said they would opt out of getting the vaccine cited safety concerns.

The poll's findings has led some public health experts to question whether enough Americans will be willing to take a vaccine that the country can achieve herd immunity, meaning enough people are immune to the virus and so it would struggle to spread further.

Boyle said he wasn't surprised by the poll's findings, although the percentages were higher than he expected. Society's ability to return to normal, however, will depend on enough of the population being willing to get vaccinated once a vaccine is ready to be distributed, he said.

He said the speed at which the vaccine candidate he's working on, AZD1222, has reached the Phase 3 clinical trials does not cause him to be concerned about the safety of the drug.

“They've done the necessary Phase 2 studies to make sure that these are safe at the doses we’re going to give to the drug, so I do feel comfortable," he said.

Scientists were able to begin identifying vaccine candidates more quickly because of their experience with the SARS and MERS outbreaks, which belong to the same family of viruses as COVID-19, Boyle said.

“We knew what we needed to target as far as a protein that would mimic the virus that the body would interpret as an infection, so there was a lot of prior knowledge that helped accelerate things,” he said.

Three Northwestern Medicine locations will be participating in the Phase 3 trial of the COVID-19 vaccine candidate produced by AstraZeneca, a biopharmaceutical company based in England – the downtown Chicago campus, Lake Forest Hospital and Central DuPage Hospital, according to a recent news release from Northwestern.

Boyle will be in charge of trial participants at the Central DuPage Hospital, providing oversight for recruitment and selection of participants as well as the administering of the vaccine, follow-up care and documentation of results.

“I’ll be speaking with them, seeing them and, if there are any complications, I would be the person that would be making sure that the patients are well taken care of,” he said.

Northwestern is looking to recruit a total of 5,000 people to participate in the Phase 3 trial as well as a variety of other studies related to COVID-19, according to a recent news release published on their website.

Specifically, they are looking for people of all ages, races and genders who work in jobs that put them at a heightened risk of being infected with COVID-19.

“We want to make sure that, if we are rolling this vaccine out to the masses, that it's going to be effective in anyone who gets it,” Boyle said. “Everyone’s immune system is different, and there's really no rhyme or reason to it.”

At Northwestern Medicine Central DuPage Hospital, Boyle said his team has a goal of recruiting 100 participants. Those patients will be given a placebo or two doses of the vaccine four weeks apart and will be monitored for a few weeks afterwards to document any potential symptoms they may experience as well as whether the vaccine protects them against infection, he said.

“The primary endpoint is does someone become infected with COVID-19,” Boyle said. “But we will also be looking at levels of antibody in blood to see how robust the immune response is.”

Northwestern is part of a larger network of hospitals participating in the Phase 3 trial across the United States and the United Kingdom, according to Boyle. AstraZeneca seeks to have a total of 30,000 participants, about one-third of whom will be given a placebo to serve as the trial's control group.

If the Phase 3 trial concludes that the vaccine is safe and effective, AstraZeneca will publish the trial's results for consideration, Boyle said. Once the U.S. Food and Drug Administration approves the use of the vaccine, it will be ready for mass production and distribution to the public.

Boyle said he is hopeful that, once more people have gotten the vaccine, others who were hesitant will feel comfortable getting it as well.

“I think it's very important for society as a whole to get this up and running,” he said.

Any individuals interested in participating in the Phase 3 trial or other COVID-19 studies can register on Northwestern Medicine's online COVID Prevention Trials Registry, by emailing nuvaccinestudy@northwestern.edu or by calling 312-694-0414.