Another AstraZeneca? Johnson & Johnson’s COVID-19 Vaccine Faces Thrombosis Concerns

Source: Beijing Business Today Authors: Tao Feng, Zhao Tianshu

As the thrombosis controversy surrounding AstraZeneca had not yet subsided, a new wave of issues emerged for Johnson & Johnson. According to a report by CBS (Columbia Broadcasting System) on April 10, eight individuals in Georgia, USA, experienced adverse reactions after receiving the Johnson & Johnson COVID-19 vaccine, prompting the state to become the third in the U.S. to temporarily suspend operations at Johnson & Johnson vaccination sites.

Although the U.S. authorities have not disclosed further details on adverse reactions, the European Union has indicated that the Johnson & Johnson vaccine may be associated with thrombosis. On the 9th, the European Medicines Agency (EMA) issued a statement reporting four cases of unusual blood clots accompanied by thrombocytopenia among recipients of the Johnson & Johnson vaccine, one of which resulted in death. Three of these cases occurred in individuals vaccinated in the United States, and one involved a participant in the vaccine’s clinical trial.

The EMA stated that authorities are reviewing cases of blood clots occurring after vaccination with the Johnson & Johnson vaccine, and it remains unclear whether there is a link between the Johnson & Johnson vaccine and blood clot issues. This marks the second COVID-19 vaccine, following the AstraZeneca vaccine, for which the European Medicines Agency is investigating post-vaccination thrombotic events.

It is worth noting that the Johnson & Johnson vaccine is currently being administered only in the United States. Although the European Union had previously approved the vaccine for marketing and administration, formal distribution and vaccination in the EU have been delayed due to the lack of deliveries from the United States. Therefore, the adverse reactions mentioned by the EMA have not yet truly affected European countries.

As of now, nearly 5 million people in the United States have received the Johnson & Johnson vaccine. After unexplained side effects were identified, multiple regions across the U.S. have urgently suspended its use.

It is reported that Colorado was the first U.S. state to suspend the use of this vaccine. On April 7, the state received reports of 11 individuals who experienced dizziness and nausea after receiving the Johnson & Johnson vaccine, prompting an emergency suspension of its administration. On April 8, following further investigation, the Emergency Medical Services department of Wake County, North Carolina, also halted the administration of the Johnson & Johnson vaccine.

The department issued a statement on the day, stating that it had examined 2,300 individuals who received the Johnson & Johnson vaccine. The county’s director of public health medicine also expressed that the occurrence of side effects following Johnson & Johnson vaccination was deeply alarming. It further emphasized the critical importance of monitoring post-vaccination responses.

Regarding the adverse reactions and thrombotic events that have emerged, a Beijing Business Today reporter contacted Johnson & Johnson, but had not received a response as of press time.

However, on the same day that the EMA issued its announcement, Johnson & Johnson released a statement indicating that it had been closely monitoring and investigating the side effects of the vaccine, with results showing that adverse events following vaccination were very rare. The company further stated that it would continue to collaborate with experts and regulatory authorities to conduct more in-depth studies on the issues associated with the vaccine.

Last Friday, Johnson & Johnson’s stock fell 1.45% to close at $160.61, marking one of the largest declines among Dow Jones Industrial Average components. Meanwhile, CNBC reported that, according to data from the U.S. Centers for Disease Control and Prevention (CDC), only 700,000 doses of the Johnson & Johnson vaccine will be allocated to U.S. states next week, a sharp drop from the 4.9 million doses distributed the previous week.

As the third vaccine authorized for emergency use in the United States, the Johnson & Johnson vaccine has generated significant anticipation among some individuals due to its single-dose regimen and less stringent storage and transportation requirements compared to mRNA vaccines such as those developed by Pfizer. The U.S. Food and Drug Administration (FDA) has stated that the Johnson & Johnson vaccine demonstrates substantial efficacy in reducing the incidence of severe COVID-19, as well as decreasing hospitalizations and deaths associated with the disease. Some even believe that the Johnson & Johnson vaccine has the potential to emerge as the most effective vaccine.

However, it was not long before issues emerged with the Johnson & Johnson vaccine. Although it has not yet been confirmed whether the reported adverse reactions are associated with the Johnson & Johnson vaccine, its credibility has once again declined.

Prior to Johnson & Johnson, another vaccine, AstraZeneca, was also embroiled in controversy over thrombotic events, leading to temporary suspension of its administration in multiple countries. The European Medicines Agency (EMA) listed thrombosis accompanied by thrombocytopenia as a rare side effect of the AstraZeneca vaccine. The World Health Organization also stated that a causal link between AstraZeneca vaccination and thrombotic events was considered "plausible but not yet confirmed."

Both the Johnson & Johnson and AstraZeneca vaccines are adenovirus vector vaccines. It is currently unknown whether the thrombotic events are associated with the adenovirus vector; if they are, Johnson & Johnson may also face similar issues.

A few weeks ago, workers at a vaccine manufacturing plant accidentally mixed up the components of the Johnson & Johnson and AstraZeneca vaccines, resulting in the destruction of approximately 15 million doses of the Johnson & Johnson vaccine.

However, vaccine expert Tao Lina analyzed to Beijing Business Today reporters that although both vaccines are adenovirus vaccines and have both shown issues with blood clots, the current evidence is not yet sufficient to definitively conclude that the vaccines will certainly cause blood clots. This is because adenoviruses are defective viruses with replication defects, meaning they cannot cause infection in the human body.

Tao Lina further stated that, given the current situation, the United States is unlikely to suspend the administration of the Johnson & Johnson vaccine, as priority remains on ensuring vaccination speed. Furthermore, even if evidence were to confirm an association with thrombosis, the incidence rate would likely be extremely low; thus, whether to proceed despite the risks remains a consideration for them.