Extended shelf life of J&J shots gives hope to doctors in Ohio
COLUMBUS (WCMH) – Some doctors in central Ohio say updated regulations are saving time in the state’s COVID-19 vaccination effort.
Johnson and Johnson announced on Thursday that they had received FDA approval to extend the shelf life of their single-dose injection from 3 months to 4.5 months. The move will push back the expiration date of millions of unused J&J doses by 6 weeks.
“The worst case scenario is having to waste these vaccines if they are past their expiration date,” said Dr. Joseph Gastaldo, infectious disease specialist at OhioHealth.
Several days before the shelf life extension, Governor Mike DeWine feared wasted doses as he called on suppliers to quickly distribute 200,000 doses of J&J which were due to expire on June 23. The Ohio Department of Health explained that 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,” saying it would save CPH time to distribute nearly 7,000 doses of J&J it had at the start of the week. It offers the option at its daily drive-thru clinic at Center Celeste and at pop-up clinics throughout the community.
“We are defusing mass vaccination centers and really trying to get vaccines to easier access points,” said Dr Gastaldo.
One of these sites at the Schottenstein Center closed at the beginning of June. The Celeste Center will stop offering the vaccine later this month. Dr Gastaldo said OhioHealth is also redirecting its resources to bring the vaccine directly to workplaces, events and communities without adequate access.
“What we have in our country is really a race to get the vaccine into people’s arms,” he said.
Across the country, the J&J hit represents approximately 11 million hits given. Pfizer and Moderna’s 2-dose series of shots collectively vaccinated the remaining 129 million Americans.
Doctors believe the single-dose distribution was affected by links to rare blood clots, prompting US regulators to suspend use for an 11-day review. Health officials ultimately determined that the vaccine’s benefits outweighed its risks.
Dr Gastaldo said the break is proof that the regulatory process is working. In its latest review, the FDA concluded that the J&J vaccine remains safe and effective for at least 4.5 months.
“The lengthening of the expiration date was based on stability studies where they actually measured the ingredients of 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 might emerge. This mechanism works.
The federal government stopped allocating J&J firing to the states on May 10. Dr Gastaldo said he was cautiously optimistic that the extended shelf life will help the state use its current supply.
He said he was less certain demand would catch up with supply anytime soon.
“Reaching 70% by July 4 – that’s a Herculean task,” Gastaldo said of the president’s national vaccination target. “At first, when I first heard about it, I thought we would never get there. So I hope I’m wrong.
Pfizer and Moderna both last up to 6 months if properly frozen, although the FDA is reviewing the shelf life of both vaccines. Ohio officials are asking suppliers to set aside all expired doses of all vaccines for use in future stability studies.