FDA extends shelf life of J&J vaccine by six weeks

US regulator’s decision based on data from ongoing stability assessment studies

A Food and Drug Administration  review concluded that the shots are safe and effective for at least four  and a half months. File photograph:  Frederic J Brown/AFP/Getty

A Food and Drug Administration review concluded that the shots are safe and effective for at least four and a half months. File photograph: Frederic J Brown/AFP/Getty

 

United States regulators have extended the shelf life of millions of Johnson & Johnson Covid-19 vaccines by six weeks.

A Food and Drug Administration (FDA) review concluded that the shots are safe and effective for at least 4½ months, the company said. The FDA originally authorised the single-shot vaccine for up to three months when stored in refrigerators of two to eight degrees Celsius.

The announcement on Thursday followed warnings from US state health officials that many doses would expire before the end of June. Many vaccine doses are being stored in hospitals, clinics and pharmacies amid a slowing vaccination campaign.

In a statement, Johnson & Johnson said the FDA’s decision was based on data from ongoing stability assessment studies.

“We continue to work with the US government and health authorities to support the use of our vaccine, which plays an important role in combatting the pandemic, including among those who wish to be fully vaccinated with one shot,” the company said.

The European Medicines Agency has approved the storage of unopened vaccines in temperatures of minus two to minus eight degrees for up to three months. Unopened vials can be stored for up to two years at minus 15 degrees to minus 25 degrees, the EMA notes, but they should not be refrozen once thawed.