This will be the third Covid vaccine granted an EUA by the US health watchdog – the FDA has not yet approved the AstraZeneca shot and has said it won’t until the outcome of an ongoing US clinical trial is known.  The green light for J&J followed positive recommendations from the agency’s own staff, as well as its advisory panel made of independent infectious disease experts, statisticians and epidemiologists, which voted unanimously in favor.

“Authorization of this vaccine expands the availability of vaccines, the best medical prevention method for Covid-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said acting FDA Commissioner Janet Woodcock. President Joe Biden has not yet named a successor for the last commissioner, Stephen Hahn, who was appointed by former president Donald Trump.

With the authorization, the FDA will require Janssen Biotech and vaccination providers to inform the US Vaccine Adverse Event Reporting System (VAERS) of any serious adverse events, including cases of multisystem inflammatory syndrome and cases of Covid that result in hospitalization or death. They must also compile monthly safety reports that also provide details of any vaccine administration errors.

This weekend’s approval will not have an immediate impact on US supply shortages, but Janssen said it expects to ramp up production over the coming weeks. The healthcare group has promised to deliver 20 million doses to state governments by the end of March, with total supply in the 2021 first half targeted at 100 million. Significant about this vaccine is that it requires only a single dose and can be stored at normal refrigerator temperatures rather than the sub-zero temperature required by the mRNA-based vaccines.

Janssen’s adenovirus vector-based vaccine is still in a Phase 3 clinical trial with 39,321 participants in South Africa, parts of Latin America, Mexico and the US. Efficacy data shared by J&J showed it to be around 67% effective in preventing moderate to severe or critical Covid 19 at least 14 days after vaccination and 66% at least 28 days after vaccination. At 72%, efficacy was better in the US, compared with South Africa with only 64%. The FDA said there is currently no evidence that the vaccination will prevent transmission of the disease.

EMA due to approve Janssen shot in mid-March

The European Medicines Agency (EMA) is expected to grant conditional marketing authorization for the J&J shot by mid-March. While the agency has not named the exact date, an an EU official told Bloomberg off the record that the green light is planned for Mar. 11. The news agency cited the same official as saying that the EMA is also talking to Russian authorities about beginning a rolling review of the Sputnik V vaccine.

Deliveries of the J&J doses to the EU are expected to begin as early as April 2021. Janssen is already producing its vaccine in Belgium, and French drugmaker Sanofi recently volunteered to help out with a plant in France. With access to four vaccines, the bloc’s 27 member states would be in a much better position to inoculate their populations in the second and third quarter after weeks of strained supply.

Carsten Watzl, head of the German Society for Immunology, meanwhile has rekindled the discussion over whether several EU countries should revisit their decisions not to offer the AstraZeneca shot to people over 65. In a BBC interview, he said this would help widen supply. Recent studies in Scotland, which have not been peer reviewed, showed the UK-developed vaccine to be effective in older people.

Watzl urged German chancellor Angela Merkel to get this shot on live TV,  “to prove it is safe.” Merkel, 66, previously said she would not get it, as she was too old.  The country’s decision to inoculate younger front-line workers with this vaccine has met with resistance, especially after severe, though temporary, reactions were observed in an early round. These workers, currently in the tier 2 priority group, could nevertheless jump the line. Up to now, Germany is sill on tier 1 and has not vaccinated anyone below the age of 80.

Author: Dede Williams, Freelance Journalist