In late April, the US regulators recommended the FDA and CDC to resume vaccinations with the Johnson & Johnson vaccine against COVID-19. They had decided that a side effect of blood clots in cerebral veins was too rare to warrant continuing the vaccination break that had previously been decided. Fifteen cases had been reported out of eight million inoculated doses. Even so, the eleven-day hiatus raised concerns about whether US citizens would trust vaccinations. Surveys had shown that trust in the Johnson & Johnson vaccine in particular is very low – the AstraZeneca, which is controversial in Germany, has not yet been used there. 73 percent of those who were not vaccinated said they were J&J not accepting would if offered to them.
This creates new challenges for doctors, public health officials and government officials who are working to ensure that everyone is vaccinated. Restoring that lost confidence will take time and effort, says Ben Weston, director of medical services for the Milwaukee County’s Wisconsin Emergency Management Office. “Everyone’s still trying to figure out the best way to communicate that it’s actually a very safe vaccine,” Weston said. “We still have to do a lot at national and international level to continue building trust in all vaccines.”
Postponement with us too
The European Union had also initially stopped the start of vaccination for the product, which was approved in mid-March, before it was used for the first time, and the manufacturer postponed deliveries. Germany was to receive a total of 36 million cans. The European Medicines Agency (EMA) initiated an investigation into thrombosis cases. On April 20, she gave the vaccine the go-ahead with the requirement that information be given about the risk. Overall, the benefits outweigh the risks.
In the meantime, on the recommendation of the Standing Vaccination Commission, Germany has lifted the prioritization for the Johnson & Johnson vaccine, although over 60-year-olds are to be given preferential access. So far, only just over 24,000 vaccine doses have been administered in this country, so the data are not yet particularly abundant. In contrast to the AstraZeneca Covid vaccine, there have been no cerebral vein thromboses so far. The Stiko is mainly based on data from the USA.
Not all experts believe the interruption will inevitably throw back vaccination efforts. Especially when vaccinations are temporarily suspended for such a rare side effect, people could feel safer – if government officials communicate the message effectively, says Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania.
“The regulators exist to protect you. They hit the pause button as soon as they saw safety concerns. So you can be confident when things can resume, ”says Fernandez Lynch, who researches the US Food and Drug Administration (FDA) and its guidelines. “The regulatory system works exactly as it is intended.”
Bioethicist Seema Shah of Lurie Children’s Hospital in Chicago also believes it would have been worse to keep giving the Johnson & Johnson vaccine without examining the clots. Nevertheless, the break was not ideal. “I always think about the counterfactual,” says Shah. “If the FDA hadn’t stopped, what kind of signal would that have sent?”
Many doctors and government officials saw the Johnson & Johnson vaccine, which uses conventional virus-based technology, as a useful alternative to the mRNA vaccines from BionTech and Pfizer, as well as Moderna. Because it only requires one dose, it works well for people who may not be staying in one place long enough to schedule a second vaccination appointment, such as college students and the homeless.
Having a choice can build confidence
Many others prefer the one-dose option simply for convenience or because they don’t like needles. Contract workers and shift workers may have tight time slots to get a vaccination appointment, making Johnson & Johnson a better option.
It is also easier to distribute and administer because, unlike mRNA vaccines, it does not require particularly cold storage temperatures. This makes it easier to vaccinate bedridden patients, people in the countryside, and patients in mobile clinics who may not have dedicated freezers.
Despite these advantages, the vaccine came across already after first Manufacturing problems and Studieswho showed it was less effective in preventing infection, raised suspicions. While the vaccines from Pfizer and Moderna prevented 95 and 94 percent of symptomatic infections, respectively, the effectiveness of the Johnson & Johnson vaccines against moderate to severe cases was 72 percent. Headlines about inferiority can add up. This must be taken into account by everyone working to build confidence in the vaccination.
“It will take some important communication for people to understand that we are not forcing them with a bad vaccine. There is no bad vaccine that we would continue to allow use, ”says Fernandez Lynch. Doctors would now have to speak to patients to gain their trust and explain the relatively low risk of side effects or offer them alternatives.
Building that trust is a long-term process. “It’s not just about today. It’s not just about the Johnson & Johnson vaccine. It’s not just about Covid vaccines. It’s about trust in science, government and public health. ”
The original version of this article is part of the Pandemic Technology Project sponsored by the Rockefeller Foundation.