COLUMBUS (WCMH) – Some Central Ohio doctors say an updated regulation is buying time in the state’s COVID-19 vaccination effort.
Thursday, Johnson and Johnson announced it received approval from the FDA to extend the shelf life of its one-dose shot from 3 months to 4 and a half months. The move will push out the expiration date for millions of unused J&J doses by 6 weeks.
“The worst-case scenario is having to waste these vaccines if they’re past their expiration dates,” said Dr. Joseph Gastaldo, an infectious disease specialist with OhioHealth.
Several days before the extended shelf life, Governor Mike DeWine feared wasted doses as he called on providers to quickly distribute 200,000 J&J doses set to expire June 23. The Ohio Department of Health explained the state cannot legally share any excess supply with other states or countries.
A Columbus Public Health spokesperson called the 6-week extension “good news,” explaining it will buy time for CPH to distribute close to 7,000 J&J doses it had at the beginning of the week. It offers the option at its daily drive-thru clinic at the Celeste Center and pop-up clinics throughout the community.
“We are de-escalating the mass vaccination centers and really trying to get vaccines to easier access points,” Dr. Gastaldo said.
One such site at the Schottenstein Center closed in early June. The Celeste Center will stop offering the vaccine later this month. Dr. Gastaldo said OhioHealth is also redirecting its resources to bring the shot directly to workplaces, events and communities without adequate access.
“What we have going on in our country is really a race to get the vaccine into people’s arms,” he said.
Nationwide, the J&J shot accounts for about 11 million shots given. Pfizer’s and Moderna’s 2-dose shot series collectively vaccinated the other 129 million Americans.
Doctors believe distribution of the one-dose shot has been affected by links to rare blood clots, which prompted U.S. regulators to pause use for an 11-day review. Health officials ultimately determined the benefits of the vaccine outweighed its risks.
Dr. Gastaldo said the pause is proof the regulatory process is working. In its latest review, the FDA concluded the J&J shot remains safe and effective for at least 4 and a half months.
“The lengthening of the expiration date was based on stability studies where they actually measured the ingredients in the vaccine to make sure everything was still active and stable,” Gastaldo explained. “There is a very robust mechanism in place to look for any safety signals that may pop up. That mechanism is working.”
The federal government stopped allocating the J&J shot to states on May 10. Dr. Gastaldo said he’s cautiously optimistic the extended shelf life will help the state use its current supply.
He said he’s less certain demand will catch up with supply anytime soon.
“Getting to 70% by the Fourth of July — that is a Herculean task,” Gastaldo said of the President’s national vaccination goal. “Initially when I first heard about it I thought we’d never get to it. So I hope I’m wrong.”
Pfizer and Moderna both last up to 6 months if properly frozen, though the FDA is reviewing both vaccines’ shelf lives. Ohio leaders are directing providers to set any expired doses of all vaccines aside to be used in future stability studies.