After the European Medicines Agency determined that the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, the company announced that it would unfreeze its European vaccinate rollout.
But assessing demand for the J&J and AstraZeneca vaccines remains difficult. The possible link to rare blood clots could elevate the role of vaccines from Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and others. And the negative attention both vaccines have received recently could coax nations to reevaluate their role in long-term vaccination campaigns.
The European Medicines Agency (EMA) recently advised that the J&J vaccine bear a warning describing a risk of rare blood clots. A similar warning could accompany the vaccine in the U.S. EMA recommended listing rare blood clots combined with low lately count as a rare side effect of the AstraZeneca vaccine.
Although the J&J vaccine had been authorized in the E.U., nations there have not yet used it. After U.S. authorities paused the use of the vaccine, Johnson & Johnson decided to suspend the distribution of the product voluntarily.
Europe has been relatively slow to vaccinate its population and has relied heavily on the AstraZeneca COVID-19 vaccine.
It is unclear what the marketplace for the J&J or AstraZeneca vaccines will be in the U.S. or Europe, said Navin Jacob, a senior equity analyst at UBS. Last week, Denmark decided not to use the AstraZeneca vaccine. “In the Western world, you might see a major issue for demand for these two [vaccines],” Jacob said.
Agnes Pannier-Runacher, France’s industry minister, recently told Bloomberg that the EU would likely cease using AstraZeneca and Johnson & Johnson vaccines in the long run.
The likelihood of regulatory authorities adding warnings about the rare risk of blood clots could exacerbate already high levels of vaccine hesitancy in the U.S and Europe. That outcome could also heighten demand for the vaccines from Moderna, Pfizer and eventually, Novavax (NSDQ:NVAX).
But the questions surrounding the J&J and AstraZeneca vaccines could hinder efforts to vaccinate the world. Because of their relatively low cost, support for high production capacity and straightforward storage requirements, both were important for vaccinating developing countries.
The recent setbacks associated with the J&J and AstraZeneca vaccines might impact the international demand for vaccines such as Russia’s Sputnik V and China’s CanSino Biologics’ COVID-19 vaccines. The Gamaleya National Research Center, which developed the Sputnik V vaccine, has claimed it is 97.6% effective. CanSino has said that a single dose of its vaccine is 65.7% effective at preventing COVID-19 symptoms.
It isn’t easy, however, to compare the safety and efficacy of those vaccines to the J&J and AstraZeneca vaccines. “When it comes to vaccines that are developed and approved outside of the Western world, there are different standards of pharmacovigilance and reporting of safety events,” Jacob said. Clinical trial protocols are not always uniformly rigorous across the world. “So, it’s hard to interpret what the true safety profile is,” he added.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease