Single-shot vaccine from Johnson & Johnson gets FDA approval, says its safe


Americans will now get a third vaccine against the COVID-19 virus. After a grueling eight hours of non-stop debate, a high-powered US vaccine advisory panel endorsed the mass use of the single-dose Johnson & Johnson vaccine.

In a 21-0 vote, the usually obscure Vaccines and Related Biological Products Advisory Committee (VRBPAC), decided that the said shot is safe in people aged 18 and older. Now, it is up to the US Food and Drug Administration.

Once the FDA clears the vaccine for US use, Johnson & Johnson will deliver 20 million doses by the end of March and 100 million by June.

Now, US regulators are drawing up the details to finalize emergency use authorization for this vaccine. The FDA has already notified federal partners involved in vaccine allocation and distribution to get ready for the rollout.

US FDA scientists have already confirmed that the Johnson & Johnson vaccine is safe and is about 66 per cent effective at preventing moderate to severe COVID-19, and about 85 percent effective against serious illness.

Minor side effects like pain at the injection site and flu-like fever, fatigue and headache may be expected.

According to the FDA, there were no COVID-19-related deaths and no COVID-19 cases requiring medical intervention 28 days or more post-vaccination among participants age 60 years or older with medical comorbidities in the vaccine group.

Once FDA clears the J&J shot for US use, only a few million doses are expected to be ready for shipping in the first week.

However, the company aims to produce around a billion doses by the end of the year. America, which began its historic vaccination drive on December 14 last year, has delivered a total of more than 70 million jabs in arms across first and second doses combined.

More than 47 million people in the US have received at least one shot. The two vaccines currently in use – Pfizer and Moderna – are both two-shot vaccines spaced about 3-4 weeks apart.

J&J tested its single-dose option in about 44,000 adults in the US, Latin America and South Africa with a 2-month median follow-up.

“The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude the issuance of an EUA,” the US FDA said of the J&J vaccine.