When Troy Petenbrink applied for a clinical trial of the COVID-19 vaccine, he thought he was playing his part in helping humanity. The first two worked, and he thought that the more vaccines there were in a desperate world.
Residents of Washington, DC received two sets of injections, placebo and the actual vaccine, from January to February and from April to May. Then he settled on what he expected to wait a bit for the Novavax vaccine to be approved by the federal government.
“I wanted something like this there,” he said, citing concerns about the safety of his 91-year-old mother-in-law from the coronavirus. “I was like,’Let’s do this, let’s roll the ball here.'”
But a few months later, he is still waiting for Novavax to apply for its approval from the Food and Drug Administration. And while other fully vaccinated people go to gyms, cinemas and bars, Petenblink struggles to convince strangers that he is protected.
“I’m really confused,” he said.
Petenbrink, a freelance travel writer, had to decline the quota because it only accepts three licensed vaccines from Pfizer (BioNTech, Moderna, Johnson & Johnson). He recently tried to go to the bar with his partner, but was rejected because he had not received one of the three FDA-approved vaccines.
“No one explained this as a possibility along the way,” he said of the clinical trial.
About 50,000 Americans were in the same situation and volunteered for either the Novavax or AstraZeneca vaccine trials.
Both vaccines show strong efficacy and safety data. AstraZeneca vaccines are distributed in the United Kingdom, Europe, and elsewhere in the world.
However, both companies refused to submit the vaccine for approval in the United States. Novabax had problems with vaccine production and AstraZeneca faced safety problems abroad.
Do I need a COVID vaccine booster shot? According to experts, this is likely, but immunodeficiency should be prioritized.
Still, Americans who had either shot have a hard time proving that they are vaccinated.
The Centers for Disease Control and Prevention did not respond to requests for comment on their situation.
Petenbrink said the CDC sent him this most vague statement, such as “You are approved for public health purposes,” when he asked.
“That’s good, but it doesn’t help me who wants to live my life and do what I want to do as a vaccinated person,” he said.
He and others have a regular CDC-issued vaccine card, but at first glance anyone who gives it notices the word “Novavax” clearly printed under the “product name”. Probably.
AstraZeneca said in a request for comment: “In line with the CDC guidance, AstraZeneca is working with the study site to provide vaccine cards to study participants who received the AZD1222.”
Novavax President and CEO Stanley Erck described the situation as a “serious problem” doing everything he and the rest of the company could handle.
“I receive more letters every day than anything else about it,” Elk said in an interview on Friday.
He said the company’s production problems have been resolved and it will probably submit the package to the FDA in October and begin distribution by early next year.
“We are planning to be full steam in 2022,” he said, explaining that Novavax is currently seeing its major role in providing booster shots.
Petembrink, who was vaccinated at Howard University, said he knew at least four other people who had dropped out of Novabax’s study and took “real” shots.
It’s not well researched, but it’s unlikely that getting additional shots will be dangerous.
and British trial People who received the Pfizer-BioNTech vaccine after the first dose of AstraZeneca were very well protected because the vaccines were mixed and adapted. However, no one received two doses before one-third of Pfizer-BioNTech, and the results of a study combining Novavax with other vaccines have not yet been published.
Petenbrink asked the CDC, the Food and Drug Administration, and Novavax for advice on what to do about safety when traveling or taking another shot, but said none of the three responded.
Despite the hassle and daily medical forms he has to fill out, Petenbrink does not regret taking part in the exam. But he is worried about the experience he will turn people off next time. “It’s a difficult message for others considering clinical trials in the future,” he said.
Contact Karen Weintraub at [email protected].
Health and patient safety coverage at USA TODAY was partially made possible by grants from the Masimo Foundation for Ethics, Innovation and Competition for Healthcare. The Masimo Foundation does not provide editorial input.
This article was originally published in USA TODAY: Novavax, AstraZeneca COVID Vaccine Trial Volunteers Waiting for FDAOK