David Zalubowski / AP
WASHINGTON – Johnson & Johnson said on Thursday that U.S. regulators have extended the expiration date of millions of doses of its COVID-19 vaccine by six weeks.
The company said a Food and Drug Administration review concluded that the injections remained safe and effective for at least 4.5 months. In February, the FDA initially cleared J & J’s vaccine for up to three months when stored at normal refrigeration levels.
Thursday’s announcement comes after state officials warned that many doses in storage would expire before the end of the month.
Vaccine expiration dates are based on information from drug manufacturers about how long the injections remain at the correct strength. J&J said the FDA added six weeks based on data from ongoing studies assessing the stability of the vaccine.
The FDA has reviewed the expiration dates of the three vaccines authorized in the United States, as companies have continued to test batches in the months since the injections first launched. The vaccines from Pfizer and Moderna, approved in December, have a six-month shelf life.
The J&J extension will help maintain vaccine supplies even as the number of Americans getting vaccinated has declined. The country averaged about 800,000 new injections per day last week. That’s down from a high of almost 2 million daily shots two months ago. Government officials and businesses have turned to incentives to encourage the shootings, including paid time off for million dollar lottery prizes.
As vaccinations have slowed, it has become clear that the United States is unlikely to meet President Joe Biden’s target of having 70% of adults partially vaccinated by July 4. About 64% of Americans over 18 have received at least one dose, according to the Centers for Disease Control and Prevention.
J & J’s vaccine was highly anticipated due to its unique formulation and easy-to-ship refrigeration. The vaccine was to play a key role in immunization campaigns in rural areas and low-income countries with limited health care infrastructure.
But rival drugmakers Pfizer and Moderna, which began shipping injections months earlier, have already supplied more than enough doses to meet U.S. demand. More than 129 million Americans have been fully immunized with the companies’ two-dose injections. In comparison, only 11 million Americans have been vaccinated with the J&J vaccine. About 10 million additional doses of J&J have been sent to states, according to the CDC.
Use of J & J’s vaccine has been compromised by links to a rare blood clot disorder. This issue led US health officials to “suspend” the use of the photo for an 11-day review. Authorities lifted the suspension in late April after concluding that the vaccine’s benefits outweighed its risks
J&J’s rollout has also been slowed down by contamination issues at a Baltimore plant that helps take the snapshots. The facility was closed after an FDA inspection revealed unsanitary conditions and other problems in April. None of the vaccines produced there have been distributed.