Yesterday, the FDA confirmed that the Johnson & Johnson jab may be linked to rare side effects consistent with a neurological condition known as Guillain-Barré. The news was only the latest revelation of a rare but potentially life-threatening side effect caused by the vaccines. Both AstraZeneca and J&J have been linked to cerebral blood clots, while the Pfizer and Moderna jabs (which use a new technology known as mRNA) have been linked to heart inflammation in a small number of patients.
Unsurprisingly, the media hasn't devoted much attention to covering these defects. Authorities like the CDC insist that the benefits of the jabs far outweigh the risks, while Dr. Fauci took to CNBC Tuesday morning to offer reassurances about J&J's new warning label while suggesting that private companies do more to coerce Americans to get vaccinated.
Fortunately for the small number of patients who are potentially at risk of developing a vaccine-induced side effect, the makers of the AstraZeneca and J&J jabs (which both use adenovirus technology) are working on modifications that could lower - or eliminate - certain dangerous side effects, according to WSJ.
Thanks to help from scientists around the world, early stage research has helped to identify what's causing the blood clots. Fast-developing clues into how the clots form (driven in part by independent scientists in Europe, the US and Canada) are boosting hopes of identifying the cause and possibly re-engineering AstraZeneca’s shot by next year, according to some of these people.
Still, it's too early to know whether either shot can be modified, or whether doing so would make commercial sense, according to WSJ's anonymous sources.
For both AstraZeneca and J&J, eliminating the rare blood-clotting issues and the other neurological symptoms described above would be major victories for two companies that have lost their leading positions in the vaccine race. The changes could even help turn the shots into "moneymakers."
But first scientists say they need to understand whether the problem is one of the ingredients in the shots, the purification process or something that's embedded in how the vaccine's work (which would be a bigger problem). Sarah Gilbert, an Oxford vaccinologist and co-inventor of the vaccine, says her team is focused on figuring out what exactly triggers the immune response underpinning the clots.
In other news, Reuters reports that European regulators haven't received key data and other materials from the creators of Sputnik V, the Russian-developed vaccine that's already being used by a small number of EU nations, but is seeking approval for use across the EU.
Sources told Reuters that the failures are likely due to the Gamaleya Institute's lack of experience in dealing with overseas regulators. "They are not used to working with a regulatory agency like the EMA," the person close to the agency said, referring to Gamaleya and its scientists.
A J&J spokesman said the company supports “continued research and analysis as we work with medical experts and global health authorities." AstraZeneca has said it is “actively working with the regulators and scientific community to understand these extremely rare blood-clotting events, including information to drive early diagnosis and intervention, and appropriate treatment."