FRIDAY, June 11, 2021 (HealthDay News) -- U.S. regulators have extended the expiration date on millions of Johnson & Johnson coronavirus vaccine doses by six weeks, the company announced Thursday.
A U.S. Food and Drug Administration review concluded the shots remain safe and effective for at least 4 1/2 months, J&J said in a statement. In February, the FDA first authorized the vaccine for up to three months when stored at normal refrigeration temperatures.
State officials had warned earlier this week that many J&J doses in storage would expire before the end of the month. The FDA change gives health providers more time to use shots sitting at pharmacies, hospitals and clinics, the Associated Press reported. Many states have adopted a "first-in-first-out" approach to try and use their oldest vaccines first.
Vaccine expiration dates are based on information from drugmakers on how long the shots stay viable. J&J said the FDA added six weeks based on data from the company's ongoing studies on the vaccine's stability.
The FDA has been reviewing expiration dates on all three vaccines authorized in this country as companies have continued to test batches in the months since the shots first rolled out. Vaccines from Pfizer and Moderna, authorized in December, have a six-month shelf life, the AP reported.
Unfortunately, vaccination rates have been dropping in recent weeks: The country averaged about 800,000 new injections per day last week. That's down from a high of nearly 2 million daily shots two months ago, the AP reported. Government officials and companies have turned to incentives to encourage shots, including paid time off and $1 million lottery prizes.
As vaccinations have slowed, Biden's goal of having 70% of adults partially vaccinated by July 4 is in jeopardy. As of Friday, roughly 64% of Americans over 18 have had at least one shot, according to the U.S. Centers for Disease Control and Prevention.
J&J's vaccine was highly anticipated because of its one-and-done formulation and easy-to-ship refrigeration. The shot was expected to play a key role in vaccination campaigns in rural areas and low-income countries with limited health care, the AP reported.
But rival drugmakers Pfizer and Moderna have already supplied more than enough doses to meet U.S. demand. More than 129 million Americans have been fully vaccinated with the companies' two-dose shots, the AP reported. Meanwhile, just 11 million Americans have been vaccinated with the J&J shot. About 10 million more J&J doses have been sent out to states, according to the CDC.
Use of J&J's vaccine appears to have also been hurt by links to a rare blood clot disorder. That issue prompted U.S. health officials to "pause" use of the shot for an 11 days. That hold was lifted in late April after officials concluded the vaccine's benefits outweighed its risks.
G-7 joins US in pledge to send vaccine doses to countries in need
The leaders of the G-7, the world's richest democracies, are expected on Friday to promise they will send 1 billion doses of COVID vaccines to poor and middle-income countries as part of a campaign to "vaccinate the world" by the end of 2022.
President Joe Biden announced on Thursday that the United States plans to purchase 500 million doses of Pfizer's coronavirus vaccine that it will then donate to countries in need around the world. As for the rest of the G-7, the U.K. will donate 100 million doses, while other members of the G-7 will contribute the rest, the AP reported.
"This is about our responsibility, our humanitarian obligation, to save as many lives as we can," Biden said in a speech in England on Thursday evening, before the G-7 meeting began. "When we see people hurting and suffering anywhere around the world, we seek to help any way we can."
The United States will send the first of its 200 million donated doses out this year, with 300 million more shared in the first half of next year, three people familiar with the plan told the Washington Post on Wednesday. COVAX, the World Health Organization-backed initiative to share COVID-19 doses across the globe, will distribute the doses to low- and middle-income countries.
Many public health experts and advocacy groups cheered the news, saying U.S. leadership on the issue will be critical to vaccinating the world.
"It's an extraordinary development," Jennifer Nuzzo, an epidemiologist and senior scholar at the Johns Hopkins Center for Health Security in Baltimore, told the Post. The plan "sends a profound signal in terms of U.S. commitment to global health security and willingness to help end this pandemic for the world and the United States," she added.
"It is meaningful, but not sufficient on its own," said Thomas Bollyky, a senior fellow at the Council on Foreign Relations and director of its global health program.
On the one hand, 500 million doses is about six times the number of doses COVAX has distributed so far, he told the Post. On the other, it is just a quarter of the 2 billion doses COVAX aims to distribute this year. So far, COVAX has delivered just under 82 million doses to 129 countries, the newspaper said.
"These Pfizer doses will go to many countries," Bollyky said. "The big question is, in what order and in what amount? That will have significant bearing on what the public health impact of the commitment will be."
The gap between vaccines haves and have-nots is wide: More than half the populations in the United States and Britain have had at least one dose of coronavirus vaccine, while fewer than 2 percent of people in Africa have gotten a shot.
"We won't end this global pandemic anywhere unless we beat it everywhere," Tom Hart, acting CEO of the One Campaign, an organization focused on fighting global poverty and preventable disease, said in a statement. "Donating doses to COVAX will save lives, reduce the spread of variants, and help reopen the global economy. We urge other G-7 countries to follow the US' example and donate more doses to COVAX. If there was ever a time for global ambition and action to end the pandemic, it's now."
The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccinations.
SOURCES: Associated Press; Washington Post