The pain in Timothy Smith's left arm had gotten worse -- "It felt like somebody had bashed my arm for a solid hour," he said -- and fatigue was starting to set in, but the 34-year-old who describes himself as "pretty all-around healthy" wasn't panicked. About a day earlier on Oct. 7, Smith had gone in for his first injection in Moderna's coronavirus vaccine trial. And because he had done research and was prepped by the clinical team, Smith said he felt equipped to handle any of the vaccine's reported side effects, which experts say are signs that the body's immune system is working.
"I was never in the dark about any of the process," said Smith, a former Washington Post staffer who is now a union organizer in the district. "I think sometimes if people don't know what to expect, that can make you a little more fearful, and they were good about laying out everything that could potentially happen." He wasn't told whether he was given the vaccine or a placebo, but he believes he was given the vaccine based on his reaction to the injections.
Ahead of the anticipated distribution of Moderna's two-dose vaccine and a similar vaccine developed by Pfizer and German biotechnology company BioNTech, which could be coming in a matter of weeks, experts have stressed the importance of transparent messaging in ensuring wide public acceptance and completion of the vaccination regimens.
Though a full detailed analysis of the safety profile of the vaccines is forthcoming and will be a topic of discussion at the Food and Drug Administration's advisory committee meetings this month, the drugmakers' disclosures about the possible side effects coupled with anecdotal reports from trial participants have prompted concern among some experts that people may be hesitant to get vaccinated or won't come back for their second dose.
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"We talk about these vaccines as being reactogenic, which is just a big word that means the way they work, you will feel that they're working," said Kelly Moore of the Immunization Action Coalition, who is also an external adviser for Pfizer's vaccine effort.
"So, it will give a reaction, and that reaction may be a sore arm or some redness where the injection was given," she said. "Or you may even feel flu-like, you may have a headache or body aches for a day or so, and it's absolutely normal. There's nothing dangerous or bad about these reactions."
But if people aren't properly informed, Moore and other experts anticipate that the vaccine rollouts "could indeed go very poorly." A Pew Research Center survey conducted in September indicated that Americans are split on whether they will get vaccinated: 51% said they would "definitely or probably" get the covid vaccine if it were available today, and 49% said they would not. Many cited concerns about side effects and uncertainty around effectiveness, according to Pew.
"If we sugarcoat it, that's going to backfire, because they're going to get the vaccine, they're going to feel bad, and then they're going to say, 'That vaccine made me sick,'" said Melanie Swift, an occupational medicine doctor helping to lead covid vaccination efforts at the Mayo Clinic. Swift noted that some people have been deterred from getting flu shots because of potential side effects, which are often mild. "This is going to be more significant," she said.
Former FDA Commissioner Mark McClellan added that the covid vaccines are "likely to be more unpleasant than a flu vaccine."
"But, on average, covid-19 is a lot worse than the flu," McClellan said.
Moderna has disclosed some reports among trial participants of "severe" side effects, or those that could impede daily activity, according to a November news release. Significant side effects from the first dose included injection site pain, but more felt worse after the second shot -- reporting fatigue, muscle and joint pain, and headache, among other symptoms.
In the Pfizer trial, participants reported fatigue and headaches after getting the second dose.
Susan Lakes, a participant in the Pfizer trial who felt fatigued, achy and nauseated after her second shot, said she was back to normal in even less time.
"It just came real fast and it went real fast," said Lakes, 66 of Cincinnati, whose side effects were gone within 24 hours.
Information for this article was contributed by Laurie McGinley, Carolyn Y. Johnson and Frances Stead Sellers of The Washington Post.