There is now concern over the possible effects on the 800,000 Johnson and Johnson vaccine order T&T is earmarked to receive from the African Medical Supplies Platform, after manufacturers Johnson and Johnson (J&J) was recently ordered by the US Food and Drug Administration (FDA) to dispose of 60 million vaccine doses due to possible contamination at a factory.
However, Health Minister Terrence Deyalsingh has said it is difficult to anticipate the possible effects at this time.
Deyalsingh indicated the difficulty in Parliament yesterday, while replying to a query from the UNC’s Rodney Charles. The latter asked how the move in the US would impact the 800,000 J&J vaccines T&T is expecting.
Reports in the US press five days ago stated Johnson & Johnson must destroy 60 million doses of its COVID-19 vaccine because they may be contaminated.
However, millions of its unused doses were given extra shelf life by regulators.
The FDA announced it had approved two batches of vaccine from the plant for use in the US or abroad, but that they are “not yet ready” to allow the plant to reopen to make new doses of the vaccine. The two batches are estimated to be about ten million doses.
The New York Times reported the approved doses will come with a warning that the FDA does not know if Emergent BioSolutions, which made the vaccines, “followed good manufacturing practices.”
The US report stated the Emergent BioSolutions was cited in 2020 for deficiencies in safety and testing and was shut down by the FDA in April for making J&J’s COVID-19 vaccines “with poorly trained workers in unsanitary conditions that allow cross-contamination of bulk drug substances.”
In April also, the FDA and the Centre for Disease Control called for a pause of the vaccine’s use while it “investigated extremely rare but serious blood clots in some women who received the vaccine.”
It was lifted ten days later. But the article stated fear of side effects “appears to have hurt demand for the vaccine.”
The Daily News stated the manufacturing problems “put J&J in a precarious situation where they’ve failed to make good on several contracts and made up for shortages by importing millions of doses” from its Netherlands factory.
Replying to Charles’ concern yesterday, Deyalsingh said, “The J&J vaccines are produced at multiple sites in the US. The affected site is called Emergent.”
He said J&J vaccines are also produced in South Africa under a technology transfer agreementand in Italy, the Netherlands, Spain, France and also in India.
“For these reasons, it is difficult to anticipate the possible effects of this so, therefore, no opinion could be put forward at this time,” the Minister said.
Deyalsingh denied Charles’ view that errors were made with vaccine supplies.
He pointed to bilateral talks which have “borne abundant fruit in the past few months.”
He cited 300,000 doses in T&T and other doses from Covax. He said talks are also on with other manufacturers.
He added, “While this (J&J issue) is something to undoubtedly take note of, as indicated, there are seven other countries currently manufacturing J&J vaccines in addition to multiple sites within the US. So it is very difficult, as I said, at this time to try to predict what the impact of this is going to have.”