The recent spectacle surrounding Vaxzevria, the AstraZeneca (LON:AZN) COVID-19 vaccine, could exacerbate vaccine hesitancy, which is significant in many parts of the world.
In the U.S., the independent data and safety monitoring board overseeing the Phase 3 trial contacted government authorities with concerns that the summary data were misleading.
More recently, the European Medicines Agency (EMA) has concluded that blood clots are a “very rare” side effect of the vaccine, and the U.K. and other countries have constrained its use. There could be a backlash against the vaccine.
People “who are anti-vaxxers are now going to go and say: ‘I told you so, we were right,’ said Iain Duncan Smith, former Leader of the Conservative Party in the U.K. “This is going to be very difficult and damaging. It plays into the hands of those who are trying their level best to disrupt the vaccination program.”
Given that dynamic, AstraZeneca should stress in outgoing communications that the vaccine’s benefits outweigh the risks, said Philipp Rosenbaum, senior pharma analyst at GlobalData.
U.K. Prime Minister Boris Johnson did that just recently, encouraging the public to get the shot. The EMA has also stressed that the benefits of the vaccine outweigh the risks.
But if the company, politicians and regulators don’t continue to hammer home that message, it could stymie vaccination efforts in the E.U. and elsewhere, Rosenbaum explained. The public is likely to hesitate to take the vaccine and opt for alternatives, which are in short supply in Europe. “Any side effects associated with these vaccines can be disastrous in the eyes of the public, and the confirmed cases of blood clots could sway their opinion in a direction which could negatively impact herd immunity,” Rosenbaum said.
Several other countries that have authorized the vaccine have constrained its use. The Netherlands, Germany and Italy have recommended that the vaccine only be used in people over 60. The U.K. has suggested that people under 30 should get an alternative vaccine.
But the vaccine limitations will make it difficult for Europe to slow the spread of contagious variants such as B.1.1.7, which has become dominant there.
Once the pandemic subsides and SARS-CoV-2 becomes endemic, Vaxzevria could have a limited role in the market, assuming that COVID-19 boosters are required. “There will be enough alternatives, and countries with the needed resources might shift towards vaccines with better efficacy and safety data,” Rosenbaum said.
The U.S. has purchased enough vaccine supplies from Pfizer, Moderna and Johnson & Johnson to vaccinate most of the population, leading the country to donate its supplies of AstraZeneca to Mexico and Canada.
Still, the AstraZeneca vaccine will be important internationally. AstraZeneca and its partner, the Serum Institute of India, are aiming to manufacture two billion doses of the vaccine to be distributed globally. “However, the company and politicians must make sure that Vaxzevria will not be seen as the vaccine that can be distributed globally, while the U.S. and European countries are trying to count on mRNA vaccines, possibly creating a two-class vaccine system,” Rosenbaum concluded.
The AstraZeneca vaccine is not yet available in the U.S. If the FDA authorizes the vaccine, it would be the fourth available in the country.