How the FDA’s pause on Johnson & Johnson could affect global performance

More than a billion people around the world have been waiting for the Johnson & Johnson vaccine – a cheap, easy-to-transport, single-dose injection to reduce the risk of COVID-19.

Now global representation is in doubt.

The U.S. Food and Drug Administration, which recommended that the vaccine be stopped this week as scientists study a possible link to extremely rare blood clots, has no jurisdiction outside the United States. But many countries follow his leadership.

The rains have already started in South Africa, where authorities have also stopped using vaccines, which were the only ones available there. In February, the country canceled plans to use AstraZeneca’s vaccine, who poorly tested the coronavirus variant that is dominant there, and is also associated with blood clots.

Experts said that while a break at Johnson & Johnson might make sense for the United States – where two other vaccines are widely available – stopping in poorer countries with fewer opportunities could end up costing much more lives than saving them.

“One of the dangers of this is how this is portrayed – that somehow they are not good enough for America, but they are good enough for the rest of the world,” said Dr. Jeremy Farrar, director of the British organization Wellcome Trust Charitable Medical Research. “There’s a risk of sending that signal.”

Even if the FDA finally clears the Johnson & Johnson vaccine, the break could still hurt global efforts by undermining confidence in the COVID-19 vaccine as a whole.

Research in South Africa has found that about 40% of people do not plan to get any stroke.

Johnson & Johnson and AstraZeneca vaccines – both of which use adenoviruses to help train the immune system – can be produced much faster and more economically than their competitors, who rely on newer mRNA technology. Because they only need refrigeration – not deep freezing – they are also easier to transport and store.

“The only way to vaccinate the rest of the world in the next 12 months is through these adenovirus vaccines,” Farrar said.

Without them, the uncontrolled spread of the disease in developing countries will increase the likelihood that new vaccine-resistant variants will emerge, he said.

Both Johnson & Johnson and AstraZeneca vaccines play a major role in Covax, a global collaboration for equitable procurement and distribution of vaccines among countries, especially the poorer ones. Each company has committed to selling hundreds of millions of doses through the initiative.

Issues related to the AstraZeneca vaccine have already been stalled in Africa, which has barely begun vaccinating its population.

The Democratic Republic of Congo has received more than 1.5 million doses, but has not yet used any for safety reasons.

The American break on Johnson & Johnson – is also on hold in the European Union while the authorities there work with the FDA to assess security data – exacerbated fears that the pandemic in Africa will last much longer than in other parts of the world.

The Chinese vaccine CanSino and the Russian vaccine Sputnik, which are also widely supplied to developing countries, use similar adenovirus technology, although countries have not yet reported safety issues. One of the adenoviruses used in Sputnik, called Ad26, is the same as the one in Johnson & Johnson.

If the distribution of adenovirus-based vaccines is disrupted, the consequences could resonate with the world in the years to come.

“We’re going to have to wait and see what the FDA finds, of course, but it would be a real shame,” said Amanda Glassman, a senior colleague and global health expert at the Center for Global Development, a nonprofit research center in Washington.

“When you sit in parts of the US and the UK, you have the feeling that this pandemic is coming to an end,” she said. “It’s not a global picture. We can’t act like this is going away any time soon. “

The FDA, as well as the U.S. Centers for Disease Control and Prevention, recommended a Johnson & Johnson break after six women, ages 18 to 48, developed a rare blood clotting disorder within three weeks of vaccination. One of the women died and the other was in critical condition on Tuesday.

Even if scientists determine that the vaccine is the cause, it seems that the rate is still less than one in a million – about half the probability of a lightning strike each year, and much less likely than a blood clot caused by oral contraceptives, because an example.

Johnson & Johnson has played only a minor role in the U.S. vaccination campaign since it was approved in February. The vast majority of Americans who signed up for this week were quickly switched to two other vaccines available in the United States – Pfizer-BioNTech and Modern.

U.S. regulators have not approved the use of the AstraZeneca vaccine, and if they do, vaccine stocks in the U.S. are unlikely to be needed here.

Although AstraZeneca remains the cornerstone of the vaccination campaign in Britain, the European Union plans to phase it out next year as Pfizer becomes more abundant. Germany, Italy and Spain have limited the AstraZeneca vaccine to the elderly.

The United States makes up about 4% of the world’s population, but nearly 30% of all vaccine doses administered worldwide. The African continent, home to 17% of humanity, makes up 2% of all shots.

Source