US extends expiration dates for J&J COVID vaccine by 6 weeks

FILE - This Saturday, March 6, 2021 file photo shows vials of Johnson & Johnson COVID-19 vaccine at a pharmacy in Denver. On Thursday, June 10, 2021, Johnson & Johnson said that the U.S. Food and Drug Administration extended the expiration date on millions of doses of its COVID-19 vaccine by an extra six weeks. (AP Photo/David Zalubowski, File)
FILE - This Saturday, March 6, 2021 file photo shows vials of Johnson & Johnson COVID-19 vaccine at a pharmacy in Denver. On Thursday, June 10, 2021, Johnson & Johnson said that the U.S. Food and Drug Administration extended the expiration date on millions of doses of its COVID-19 vaccine by an extra six weeks. (AP Photo/David Zalubowski, File) (Copyright 2021 The Associated Press. All rights reserved.)

WASHINGTON – Johnson & Johnson said Thursday that U.S. regulators extended the expiration date on millions of doses of its COVID-19 vaccine by six weeks.

The company said a Food and Drug Administration review concluded the shots remain safe and effective for at least 4 1/2 months. In February, the FDA originally authorized 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. The change gives health providers more time to try and use remaining J&J shots sitting at pharmacies, hospitals and clinics. 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 at the right strength. J&J said the FDA added six weeks based on data from ongoing studies assessing the vaccine’s stability.

The FDA has been reviewing expiration dates on all three U.S. authorized vaccines 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 J&J extension will help maintain vaccine supplies even as the number of Americans getting shots has slipped. 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. Government officials and companies have turned to incentives to encourages shots, including paid time off and $1 million lottery prizes.

As vaccinations have slowed it's become clear the U.S. is unlikely to meet President Joe Biden's goal to have 70% of adults partially vaccinated by July 4. Roughly 64% of Americans older than 18 have had at least one dose, according to the 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 infrastructure.