J&J and AstraZeneca COVID-19 Vaccines: U.S. Pauses Use Amid Blood Clot Concerns, EU to Not Renew Supply Contracts

Text | newborn & Liuqi

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Following the AstraZeneca COVID-19 vaccine, the Johnson & Johnson COVID-19 vaccine has also fallen victim to a “vaccination pause.”

Recently, the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) issued a joint statement: Six cases of “rare and severe” blood clots have been identified in the United States, which appear to be associated with Johnson & Johnson’s COVID-19 vaccine. Out of an abundance of caution, it is recommended that vaccination with the Johnson & Johnson COVID-19 vaccine be paused.

According to the joint statement, more than 6.8 million people in the United States have received the Johnson & Johnson vaccine. To date, all six identified cases of blood clots have occurred in women aged 18 to 48 years. Cerebral venous sinus thrombosis (CVST) and low platelet counts (thrombocytopenia) were observed in these six patients, with symptoms appearing 6 to 13 days after vaccination. The joint statement pointed out that the treatment for CVST differs from that for typical blood clots. While typical blood clots can be treated with the anticoagulant heparin, “heparin may be dangerous in cases of CVST, and alternative treatment options should be administered.”

It is worth noting that on April 13, based on the discussion results of the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) meeting, Johnson & Johnson made the decision to proactively postpone the rollout of its vaccine in Europe and suspend all clinical trial vaccinations.

Previously, the AstraZeneca COVID-19 vaccine was also suspended due to rare thrombotic events. According to the latest data published in an article in Science magazine, at least 222 suspected cases have been reported among 34 million vaccine recipients in Europe, with more than 30 deaths. Although the European Commission has completed a subsequent safety review and concluded that the benefits of the vaccine outweigh the risks, several countries have still paused or restricted its administration, with Denmark announcing a complete halt to the use of this vaccine.

On the 14th local time, Danish authorities stated that the investigation into the AstraZeneca thrombosis incident “revealed real and serious side effects,” leading to the decision to completely halt the use of this vaccine. AstraZeneca responded by respecting Denmark’s choice and committing to continue providing data to inform future decisions.

Reuters reported that Denmark is the first country to completely stop using the AstraZeneca vaccine.

However, AstraZeneca has been struggling to meet the initial delivery targets stipulated in the contract.

EU Does Not Renew Procurement Contract, Turns to Pfizer Instead

Both the AstraZeneca and Johnson & Johnson COVID-19 vaccines are adenovirus-based vaccines. Due to thrombotic events and delivery delays, Europe is seeking vaccine supplies for 2022. On Wednesday, the Italian newspaper La Stampa quoted an anonymous source from the Italian Ministry of Health as saying that the European Commission has decided not to renew its vaccine contracts with AstraZeneca and Johnson & Johnson after they expire at the end of the year. Currently, neither Johnson & Johnson nor AstraZeneca has commented on this report.

Reports stated that AstraZeneca initially committed to delivering 90 million doses to the European Union in the first quarter of 2021, but slashed its target to 31 million in January, sparking a heated dispute between the company and Brussels officials. Ultimately, the company announced it would strive to deliver 40 million doses, but by mid-March, it revised the figure back down to 30 million. In last month’s supply update, AstraZeneca indicated it would deliver 100 million doses to Europe in the first half of the year, representing a two-thirds reduction from its previous target of 300 million doses.

Johnson & Johnson informed European officials in early March that meeting its second-quarter delivery targets was “under significant pressure.” According to Reuters, Johnson & Johnson “committed to delivering 200 million vaccine doses to the European Union in 2021, starting in the second quarter.” At the time, reports suggested that the company might still be able to meet this target. However, Johnson & Johnson has now voluntarily announced a delay in the rollout of its vaccine in Europe. On Tuesday, Reuters reported that the European Commission had requested an explanation from Johnson & Johnson regarding the “completely unexpected” delay in deliveries.

According to La Stampa, for Europe, the EU may now largely rely on mRNA vaccines from Pfizer/BioNTech and Moderna.

Reuters cited an EU official last week as saying that approval from member states is currently being sought to ensure that Pfizer/BioNTech delivers 1.8 billion doses in 2022 and 2023, with approximately half of these doses being optional. Meanwhile, the price of the company’s mRNA vaccine, Comirnaty, is also rising.

According to Business Today, Bulgarian Prime Minister Boyko Borissov stated on Sunday that the European Union is negotiating a new contract with Pfizer at a price of €19.50 ($23.22) per dose. The vaccine was initially priced at €12 per dose, later increasing to €15.50.

CanSino Biologics’ Stock Price Falls Sharply; Company Issues Urgent Response

In China, as CanSino’s vaccine is also an adenovirus vector vaccine like those of AstraZeneca and Johnson & Johnson, its A-shares and H-shares both plunged on the 14th. The A-shares fell by more than 13% at one point, while the H-shares dropped by over 17%.

In response, on the 14th, CanSino Biologics issued an urgent announcement on the Hong Kong Stock Exchange: The Company has noted media reports regarding rare and severe thrombotic events in individuals following vaccination with the AstraZeneca COVID-19 vaccine and the Johnson & Johnson COVID-19 vaccine. The chimpanzee adenovirus vector used in the AstraZeneca COVID-19 vaccine differs from the human adenovirus serotype 26 (Ad26) vector used in the Johnson & Johnson COVID-19 vaccine. As of the date of this announcement, no serious adverse events related to thrombosis have been reported among the approximately one million recipients of the recombinant novel coronavirus vaccine (Ad5-nCoV).

However, in September 2011, researchers including Yu Xiunan from the First Affiliated Hospital of Harbin Medical University published an article titled “Research Progress on Type 5 Adenovirus Vectors and Thrombocytopenia” in the Journal of Modern Laboratory Medicine. The article noted that thrombocytopenia is a major side effect observed after high-dose systemic administration of adenovirus vector-based gene therapy carriers. Adenoviruses can bind to CAR receptors on platelets, as well as to integrin receptors on platelets. “Recent studies have found that adenoviruses may induce platelet activation. Adenovirus-induced thrombocytopenia is considered to be dose-dependent, saturable, and reversible, which is consistent with ligand-receptor mechanisms; various perspectives exist regarding this mechanism.”

However, these studies are based on the results of high-dose systemic therapeutic applications, and how CanSino vaccines actually perform may require further observation and research.

Shortly after CanSino Biologics issued its statement, the decline in its share price began to narrow. As of the market close this afternoon, CanSino’s A-shares had cumulatively fallen 8.36% over the past three trading days, closing at RMB 348.33, while its H-shares had cumulatively dropped 14.39% over the same period, closing at HKD 267.80 per share.

Reference Source:

CDC, FDA Recommend Pausing J&J COVID-19 Vaccine Rollout Over Blood Clots

China Times: Overseas COVID-19 Vaccine “Clotgate” Escalates: Following AstraZeneca, Johnson & Johnson Vaccine Urgently Suspended, CanSino Biologics’ Stock Price Affected