Experimental coronavirus vaccines: When they will roll out, side effects and what it all means for you

CLEVELAND, Ohio — When University Hospitals needed volunteers willing to test an experimental vaccine for COVID-19, UH’s Dr. Margaret Larkins-Pettigrew signed up, and brought along her physician husband as well.

The couple learned they will undergo two injections of either the vaccine or a placebo; they won’t be told which they were given.

Over the next two years, they will undergo periodic physicals, keep track of their symptoms and turn over their medical records to trial organizers if they are hospitalized for COVID-19.

Larkins-Pettigrew said she felt an obligation, as a physician, to participate in the vaccine trial.

“This is a safe trial to be involved in,” said Larkins-Pettigrew, who is UH Edgar B. Jackson chair of Clinical Excellence & Diversity. “Science will direct us to make sure all of us are protected.”

All over the world, people like Larkins-Pettigrew are signing up to help pharmaceutical companies test prospective COVID-19 vaccines, as part of an effort to get vaccines to the public and stop the pandemic’s devastating effect.

In Ohio, Pfizer and its partner BioNTechSE, and Moderna — forerunners in the race to develop a vaccine — are conducting trials at research centers across the state to determine their safety and efficacy.

Ohio State University Wexner Medical Center is the site of a two-year, Phase 3 trial of the vaccine developed by AstraZeneca, a British-Swedish company, and the University of Oxford.

University Hospitals and the Louis Stokes Cleveland VA Medical Center are among 120 clinical investigational sites around the world that will collectively enroll up to 44,000 participants in a Phase 3 trial to test the vaccine BNT162b2, developed by Pfizer and the German company BioNTechSE.

Rapid Medical Research Inc., in Beachwood is testing the mRNA-1273 vaccine from Moderna in a two-year trial. Two sites in Cincinnati are also testing this vaccine.

How much protection will these vaccines offer? Will we need to get a coronavirus shot every year?

“These are all open questions,” said Dr. Carlos Malvestutto, assistant professor of infectious disease and co-chair of the COVID-19 Task Force, at Ohio State University Wexner Medical Center.

“The only way to answer them is through clinical trials,” Malvestutto said.

The public has questions as well, such as how these vaccines work inside the body, why some trial participants receive a placebo and how to join a trial.

Let’s get some answers.

How do these vaccines work?

All vaccines trigger the body’s immune system to mount a defense against invading illnesses. The approach taken by AstraZeneca is different from how Pfizer and Moderna are approaching the problem.

AstraZeneca’s vaccine uses a modified chimpanzee adenovirus, altered to make it harmless to humans, Malvestutto said. The adenovirus is used as a viral vector to carry a single coronavirus gene into the body. The coronavirus components of the vaccine spark an immune response against the actual coronavirus.

The vaccine does not include the whole virus and cannot cause COVID-19, Malvestutto said.

The Pfizer vaccine candidate is made up of messenger RNA coupled to a

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Getting Vaccine Doubters to Roll Up Their Sleeves Won’t Be Easy

(Bloomberg) — Eddie Rice is a believer in vaccines. The Melbourne locksmith has received jabs in the past and understands that they go through rigorous testing before they’re rolled out. This time, as researchers sprint ahead with potential shots to protect the world against Covid-19, he’s not so sure.


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“This is a pretty unique one, just because it’s going to be so quick,” said Rice, 29. “I don’t know enough of the science to know 100% that it’s safe.”

Governments and drugmakers have long faced skepticism, and even hostility, from a small but vocal group of anti-vaccination campaigners. In the battle against the coronavirus, they may also run into reluctance from a broader swath of the population — people like Rice who would normally be on board.

Fading trust in governments, political interference and the dash to create a shot in record time are sowing doubts. Temporary halts to studies because of unexplained illnesses in volunteers — a part of vaccine development that doesn’t usually make headlines — add to the anxiety. These misgivings could hobble the high-stakes quest to slow a pathogen that’s killed 1.1 million people.

Assuming immunizations can be successfully developed, mass produced and deployed, vaccine advocates will need to convince enough people the shots are key to ending the crisis. In a survey of 20,000 people conducted over the summer, more than a quarter of respondents said they wouldn’t get a Covid shot. Russia, Poland, Hungary and France had the lowest support, the World Economic Forum and Ipsos study showed.

a person wearing a mask: Post-Registration Trial of RDIF's 'Sputnik V' COVID-19 Vaccine

© Bloomberg
Post-Registration Trial of RDIF’s ‘Sputnik V’ COVID-19 Vaccine

The effort to overcome that sentiment will start with health workers. Medical staff are at heightened risk of catching the virus and spreading it to others, and will likely be among the first to get immunized. Any worries they have about the quality of a vaccine could hamper wider acceptance.

Nor should their support be taken for granted. Medical workers would be careful not to damage the trust they’ve earned by promoting a product they don’t have faith in, said Sara Gorton, head of health at Unison, a union in the U.K. representing nurses, paramedics and others in the field.

“If health-care workers are going to be expected to advocate for the vaccine, then their natural concerns will have to be addressed in advance,” she said. “It’s not going to help with take-up if you go to have your jab and the person who gives it to you isn’t able to say reassuring things.”

A study in Hong Kong earlier this year found that only 63% of nurses expressed a willingness to get a potential Covid shot. It cited uncertainty over effectiveness, side effects and how long protection would last. Support was higher as cases surged, but slipped as infections ebbed, according to researchers including Kin On Kwok, an epidemiologist at the Chinese University of Hong Kong.

If less than two thirds of nurses during an outbreak intend to get immunized, “we anticipate that

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