Has the US Damaged Africa’s COVID-19 Vaccination Drive?

LONDON – The United States Food and Drug Administration’s recent decision to limit the use of the Johnson & Johnson COVID-19 vaccine to adults who cannot or will not get another vaccine will have profound consequences for African countries. The FDA said its move reflected the risk that the vaccine might cause a rare blood-clotting syndrome. But the decision shows that, even after two years of the pandemic, the needs of people in low- and middle-income countries, and Africans in particular, remain an afterthought for leading global health authorities.

The FDA’s restriction is not based on new evidence, but rather reflects an abundance of caution in a country with a relatively high COVID-19 vaccination rate and widely available alternative vaccines. The US has vaccinated more than 65% of its population against COVID-19, predominantly with Pfizer and Moderna vaccines. Only 8% have received the J&J vaccine. So, the FDA’s decision will have little material impact in America.

In Africa, on the other hand, the J&J vaccine is widely used. According to analysis from the Tony Blair Institute for Global Change, 42 million J&J doses have been administered in African countries so far. The fact that it requires only a single shot makes it well-suited to the logistical and capacity constraints of many poorer countries, and it is the vaccine of choice across much of the continent.

Moreover, data from South Africa, where more than 8.5 million doses of the J&J vaccine have been administered – including through the Sisonke study, a vaccine trial involving health-care workers – indicate that the FDA’s extreme caution is unwarranted. And in countries where COVID-19 vaccination options are more limited, increasing conjecture about the J&J vaccine will significantly exacerbate the challenge of immunizing the population.

The FDA’s decision risks triggering a widespread loss of confidence in the J&J vaccine, causing demand to plummet and irreparably reducing the reach of a safe, effective, and widely available means of protection against COVID-19. This will have major implications for African countries’ ongoing efforts to stimulate vaccine demand and safeguard their populations.

The Tony Blair Institute for Global Change estimates that African countries have about 135 million J&J vaccines in stock, approximately 25% of which are donated doses from the US. Vaccine donations are welcome, of course, and African governments are committed to turning doses into vaccinations. But when the donor country deems those vaccines too dangerous for its own population, Africans will resoundingly refuse to accept them.

Shockwaves from the FDA’s decision will also extend to domestic manufacturing of vaccines in Africa. A leading South Africa-based pharmaceutical firm, Aspen Pharmacare, is the first African manufacturer to package, sell, and distribute the J&J COVID-19 vaccine under its own brand. The US advocated for the deal, and J&J had agreed potentially to expand it to cover more advanced versions of the vaccine such as variant-specific shots.

The FDA decision will undermine many of the concrete steps taken by the US and African countries to bolster the continent’s health and vaccine security. It will also affect the ongoing negotiations between the Africa Centers for Disease Control and Prevention, Aspen Pharmacare, and the COVID-19 Vaccine Global Access (COVAX) facility regarding a possible deal to procure and distribute the South African J&J vaccine.

It is particularly troubling that the FDA made its announcement without considering the implications for other jurisdictions or giving them advance notice so that they could respond appropriately. Although the South African Health Products Regulatory Authority released a statement reassuring the public of the vaccine’s safety and effectiveness, a decision with regional implications requires a regional approach. Had the Africa CDC known in advance of the FDA’s decision, it could have addressed anticipated concerns across the continent.

Looking ahead, the recently established African Medicines Agency could take such regional actions. A well-functioning AMA, working alongside the Africa CDC, will improve the continent’s capacity to provide speedy evidence-based responses to regulatory decisions elsewhere.

Finally, this episode is symptomatic of a wider problem in the Global North, where leaders and policymakers consistently fail to consider others’ perspectives and to recognize that their actions have wide-reaching effects beyond their own borders. Africans are global citizens and obtain their information from the same media sources as Europeans and North Americans. They are thus influenced by messages that may not be relevant to their context. In 2021, for example, some European Union countries’ suspension of the Oxford-AstraZeneca COVID-19 vaccine hit demand in Africa, likely costing thousands of lives.

The expertise of stringent regulatory bodies such as the FDA, the UK Medicines & Healthcare Products Regulatory Agency, and the European Medicines Agency is globally recognized and respected. These institutions must therefore consider the wider and unintended consequences of their decisions, particularly amid a global pandemic.

The FDA’s recent tightening of restrictions on the J&J COVID-19 vaccine is not the first time that a health-related announcement by the US or other authority in the Global North has had far-reaching consequences for Africa, and it will not be the last. To manage COVID-19 and future pandemics effectively, policymakers must collaborate now to reduce the frequency and mitigate the impact of such decisions.