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The preliminary results for Johnson & Johnson’s (J&J) late-stage Covid-19 vaccine trial should be available by January 21 and will then be submitted to the US Food and Drug Administration, according to the protocol chair for the local arm of the trial, Medical Research Council president Glenda Gray.
SA has a particularly keen interest in J&J’s shot because local pharmaceutical manufacturer Aspen Pharmacare secured a deal with the US-based firm in November that will see it fill and package as many as 300-million vials per year at its sterile plant in Port Elizabeth.
J&J has previously said that if the vaccine proves safe and effective, it will aim to provide 1-billion doses in 2021.
J&J has already entered into advance purchase agreements for hundreds of millions of doses of its candidate shot with the EU, UK, US and Canada but does not at this stage have one with SA.
Last week, the health department said discussions with J&J were "at an advanced stage".
It has paid a deposit to the international vaccine financing initiative Covax.
J&J’s candidate vaccine is being tested in a phase 3 trial on 45,000 volunteers in SA, the US and Latin America. It is being closely watched by governments around the world. If it proves safe and effective, it could potentially be scaled up far quicker than some of the products already on the market.
Unlike the mRNA vaccines developed by Pfizer and Moderna, J&J’s Ad26 CoV2-S requires only a single shot and does not need ultra-cold refrigeration. It is also expected to cost a fraction of these hi-tech vaccines.
Aspen said it had no further information to communicate about the J&J agreement. "It is premature to speculate on any further developments," it said in response to Business Day’s request for comment.
J&J has previously committed to not-for-profit pricing during the pandemic.
Gray said the price of the vaccine is expected to be between $3 (R47) and $4.
She said scientists are worried about the rapidly spreading new SARS-Cov-2 variant detected in SA and would use several techniques to determine whether its specific mutations rendered J&J’s candidate vaccine less effective. These include comparing the shot’s efficacy across different regions, genetic sequencing of "breakthrough" infections in people who had received the shot and investigating whether the new variant is less susceptible to the antibodies induced by the vaccine.
The new variant, called 501Y.V2, contains a host of mutations, some of which make it more contagious. It is driving a resurgence of infections in SA, which has recorded more cases than any other African country. By Sunday, SA had recorded 1.23-million cases of Covid-19 and 33,163 deaths.
Scientists are concerned that one of the mutations in 501Y.V2, called E484K, makes the SARS-Cov-2 virus less susceptible to neutralising antibodies. This mutation is not seen in the new and highly transmissible variant that emerged recently in the UK.
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