EU Tightens Vaccine Export Restrictions... "J&J Also Under Review for Controls" (Comprehensive)

"Vaccine Manufacturers Failing to Meet Supply Quotas Face Offshore Export Ban"
J&J Likely Included in Q2 Delays... US Faces AZ Controversy

Ursula von der Leyen, President of the European Commission [Image source=Reuters Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] Major countries are experiencing confusion over the COVID-19 vaccines. The European Union (EU), which is in conflict with the United Kingdom over vaccine procurement, has decided to further strengthen controls on exports outside the bloc. The United States raised suspicions that the AstraZeneca clinical trial results may have included outdated information.

According to major foreign media on the 23rd (local time), the EU Commission is scheduled to adopt a revised proposal on the 24th to strengthen export controls not only on the UK but also on other countries with high vaccination rates.

◆ Export Ban if Contract Not Fulfilled= This measure, based on the vaccine export control measures introduced by the EU in January, targets manufacturers who fail to meet their contracted volumes within the EU. Similar to Italy’s refusal earlier this month to allow the export of AstraZeneca vaccines to Australia, manufacturers who fail to fulfill their supply commitments will be prohibited from exporting outside the bloc.

This is essentially aimed at countries like the UK and the US that produce vaccines domestically but either do not export or restrict the export of vaccine raw materials. Countries with high vaccination rates or those restricting vaccine raw material exports are also included. An EU official explained, "The goal is to balance vaccine export and import volumes to make vaccine trade reciprocal and proportional."

Not only AstraZeneca, which triggered conflicts between the EU and Europe, but Johnson & Johnson (J&J) is also expected to be included. Johnson & Johnson recently notified Europe of delays in second-quarter supplies. An EU official emphasized, "We will not repeat the supply delays like those of AstraZeneca in the first quarter."

However, Pfizer and Moderna are unlikely to be affected. Major foreign media explained, "Although both companies supplied vaccines later than promised to the EU, they generally met the contracted first-quarter volumes."

◆ US Raises "Questions on AZ Clinical Trials"= The US National Institute of Allergy and Infectious Diseases (NIAID) raised suspicions that the AstraZeneca large-scale clinical trial results conducted in the US may have included outdated information. After being informed of this at the US Drug Safety Monitoring Board (DSMB) the previous day, NIAID said, "DSMB expressed concerns that if outdated information is included, the vaccine efficacy data cannot be fully assessed."

The US health authorities took issue with the additional clinical trial results announced by AstraZeneca on the 21st. AstraZeneca stated that in an additional clinical trial conducted on over 30,000 people in the US, their COVID-19 vaccine showed an efficacy of 79%.

On the same day, NIAID Director Anthony Fauci appeared on ABC and said, "After DSMB saw AstraZeneca’s press release, they felt the clinical data was somewhat outdated and could cause some misunderstanding," adding, "We emphasized that AstraZeneca must submit accurate data to DSMB to confirm the contents of the press release based on the clinical results."

In response, AstraZeneca stated, "We will immediately cooperate with DSMB to share initial analyses based on the latest efficacy data and announce the results within 48 hours." AstraZeneca plans to apply for emergency use authorization from the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) in early to mid-next month based on the additional clinical results conducted in the US.

This content was produced with the assistance of AI translation services.