How FDA Pause on Johnson & Johnson May Affect Global Deployment
More than a billion people around the world have been waiting for the Johnson & Johnson vaccine – an inexpensive, easy-to-carry one-dose injection that reduces the risk of COVID-19.
Now the global rollout has been in doubt.
The United States Food and Drug Administration, which this week recommended suspending use of the vaccine while scientists study a possible link to extremely rare blood clots, has no authority outside the United States. But many countries are following his example.
The fallout began in South Africa, where authorities also suspended use of the vaccine, the only one available in the country. In February, South Africa scuttled plans to use AstraZeneca’s vaccine, which was poorly tested against the dominant coronavirus variant there and which has also been linked to blood clots.
Experts said that while the break on Johnson & Johnson might make sense for the United States – where two other vaccines are widely available – shutdowns in poorer countries with fewer options would end up costing many more lives than ‘they do not save.
“One of the dangers of this is the way it’s portrayed – that they’re not good enough for America but good enough for the rest of the world,” said Dr Jeremy Farrar, director of the Wellcome Trust , a British medical organization. charitable research. “There is a risk of sending this signal.”
Even if the FDA ultimately clears the J&J vaccine, the hiatus could hurt the global effort by undermining general confidence in COVID-19 vaccines.
In South Africa, polls have found that around 40% of people do not plan to get the vaccine.
Vaccines from Johnson & Johnson and AstraZeneca – both of which use adenoviruses to help train the immune system – can be made much faster and more economically than their competitors, which rely on newer mRNA technology. . Because the J&J and AstraZeneca vaccines only require refrigeration – not freezing – they are also easier to transport and store.
“The only way to vaccinate the rest of the world over the next 12 months is to use 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.
J&J and AstraZeneca vaccines play a major role in COVAX, a global collaboration to buy and distribute vaccines equitably in countries, especially the poorest. Each company has pledged to sell hundreds of millions of doses as part of this initiative.
The questions surrounding the AstraZeneca vaccine were already a setback for Africa, which has barely begun to vaccinate its population.
The Democratic Republic of the Congo has received more than 1.5 million doses but has not yet used one due to security concerns.
The United States takes a break on J&J – it is also on hold in the European Union as authorities there work with the FDA assess safety data – heightened fears that the pandemic will spread in Africa much longer than in other parts of the world.
The Chinese CanSino and Russian Sputnik V vaccines, which are also widely supplied to developing countries, use similar adenovirus technology, although countries have not reported any safety concerns. One of the adenoviruses used in Sputnik, called Ad26, is the same one used in Johnson & Johnson’s vaccine.
If the distribution of adenovirus-based vaccines is hampered, the repercussions could reverberate around the world for years to come.
“We’ll have to wait and see what the FDA finds, of course, but that would be a real shame,” said Amanda Glassman, senior researcher and global health expert at the Center for Global Development, a nonprofit think tank in Washington. . .
“When you sit down in parts of the United States and the United Kingdom, you get the feeling that this pandemic is coming to an end,” she said. “It’s not the big picture. We cannot act as if this is going to go away soon. “
The FDA and the U.S. Centers for Disease Control and Prevention recommended the Johnson & Johnson break after six women, ages 18 to 48, developed a rare blood clotting disorder within three weeks of being vaccinated. One died and another was in critical condition this week.
Even though scientists determine that the vaccine is the cause of the blood clots, the rate of such a reaction appears to be less than 1 in a million – about half as likely as being struck by lightning each year and much less likely. than a blood clot. caused by oral contraceptives.
Johnson & Johnson has played a minor role in the US vaccination campaign since its vaccine was cleared in February. The vast majority of Americans who signed up to receive it last week were quickly switched to the other two vaccines available in the United States: those from Pfizer-BioNTech and Moderna.
US regulators have not authorized the use of the AstraZeneca vaccine; if they do, the vaccine stored in the US is unlikely to be needed here.
While AstraZeneca remains the foundation of Britain’s vaccination campaign, the EU plans to phase it out next year as the Pfizer option becomes more abundant. Germany, Italy and Spain have limited use of the AstraZeneca vaccine in the elderly.
The United States makes up about 4% of the world’s population, but almost 30% of all vaccine doses administered worldwide. Africa, home to 17% of humanity, accounts for 2% of all shots.