15 million doses of Johnson & Johnson's COVID-19 vaccine are contaminated! FDA urgently stops

Recently, Emergent BioSolutions, the manufacturer of Johnson & Johnson's COVID-19 vaccine, has encountered raw material mixing and a large number of production safety issues. The US FDA has requested Emergent BioSolutions to suspend the production of Johnson's COVID-19 vaccine at its Baltimore plant. As an important part of Johnson & Johnson's COVID-19 vaccine manufacturing network, Emergent's production accident has caused at least 15 million doses of Johnson & Johnson's COVID-19 vaccine to be contaminated.

On April 12, the FDA inspected the plant. Not long after, the regulatory agency stated that the Emergent plant should immediately stop the production of the COVID-19 vaccine before the completion of the comprehensive evaluation and regulatory report. The main reason for the suspension is that Emergent may be suspected of mixing two different carriers of COVID-19 vaccine, Johnson & Johnson and AstraZeneca.

Although both of these two vaccines use harmless viruses as the COVID-19 vaccine carrier, the two COVID-19 vaccine carriers of Johnson & Johnson and AstraZeneca are biologically different, and the two COVID-19 vaccines The carrier cannot be used interchangeably in the production process. In late February, one or more employees at the Emergent factory confused the two different carrier components. At that time, Emergent pointed out that the quality control system designed by the company could identify the links where violations occurred and isolate contaminated batches.

However, the facts may not be as simple as Emergent estimated. During the inspection recently concluded by the FDA, nine more defects in the Emergent plant were discovered. One of them is Emergent's failure to train employees in adequate manufacturing and quality control. In addition, the inspection also found that the equipment at the Emergent plant was not up to standard in size and did not properly store the pharmaceutical ingredients in accordance with pollution prevention standards. What's more serious is that the buildings of the Emergent factory do not have clean and hygienic conditions. In other words, in addition to the mixing of raw materials, the Emergent factory has problems in manufacturing, quality control, and sanitary conditions, which may also affect the safety of the COVID-19 vaccine.

Due to the seriousness of the situation, the Chairman of the U.S. House of Representatives Oversight and Reform Committee Carolyn B. Maloney and the Chairman of the Coronavirus Crisis Ad Hoc Subcommittee James E. Clyburn have sent a joint letter to Emergent CEO G. Kramer and the company’s executive chairman Fuad El-Hibri , Asked the two persons in charge to testify and accept questions on the Coronavirus Subcommittee on the morning of May 19, Eastern Time.

This is not the first time Emergent has a problem. According to reports, the FDA's investigation of the Baltimore plant in April 2020 indicated that Emergent did not even have qualified personnel to produce the coronavirus vaccine. Another inspection conducted in June revealed that the FDA found that Emergent's production plan was not perfect due to insufficient staff training and poor quality control.

In addition to production problems, the safety of Johnson & Johnson's COVID-19 vaccination has also attracted the attention of global regulatory agencies. The vaccine is still on hold in the United States, and regulatory agencies are also investigating cases of blood clotting in the Johnson & Johnson COVID-19 vaccine.

The European Medicines Agency recently released research conclusions, suggesting that there may be a link between the Johnson & Johnson COVID-19 vaccine and the occurrence of thrombosis. The committee evaluated all the evidence currently available, including 8 reports from the United States of severe cases of thrombosis and low platelets after being vaccinated by Johnson & Johnson. In addition, the European Medicines Agency believes that Johnson & Johnson's case is "very similar" to the case of thrombosis after the AstraZeneca COVID-19 vaccine.

Emergent said it has destroyed 15 million doses of contaminated Johnson & Johnson vaccine. Until the investigation determines whether other vaccines are also affected by this problem, it is expected that the production of 62 million doses of COVID-19 vaccine will be shelved. According to Johnson & Johnson’s first-quarter earnings report, the company’s sales in the first quarter reached 22.32 billion U.S. dollars, an increase of 7.9% year-on-year, and the sales of COVID-19 vaccines in the first quarter reached 100 million U.S. dollars.