Janssen COVID-19 Vaccine – one regulator blocks use, another promotes it
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
The European Medicines Agency (EMA) has announced that – as a precaution to safeguard the quality of vaccines – EU authorities are recommending preventing the release of batches of Janssen COVID-19 Vaccine containing active substance made around the time of a report of contamination.
EU authorities were made aware that a batch of active substance for the Janssen COVID-19 Vaccine had been contaminated with materials for another vaccine, both manufactured at a site owned by Emergent Biosolutions in Maryland, US.
This site was ordered to stop manufacturing while the US Food and Drug Administration (FDA) conducted an inspection earlier in the year. According to the EMA, EU authorities are aware of the FDA review and will “work with the agency and other international partners to ensure that vaccines in the EU meet the highest standards of quality.”
The batch concerned was not intended for the EU market and, based on available evidence, the authorities believe batches of the vaccine released in the EU are not affected by the cross contamination. However, as a precaution the supervisory authorities have recommended not releasing vaccine batches containing active substance made at around the same time that the contamination occurred.
These authorities said they are doing everything possible to safeguard supplies and mitigate the effects of any delay in the delivery of this vaccine.
The manufacturing issues at Emergent Biosolutions are not related to EMA’s recent review of very rare cases of blood clots and low blood platelets.
On the same day, the FDA announced that, to increase availability of the Janssen COVID-19 vaccine, it is authorising the emergency use of two batches of Janssen COVID-19 Vaccine drug substance manufactured at the Emergent BioSolutions facility.
According to the FDA, in making the decision it conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use.
The agency did reveal that it has identified several batches that are not suitable for use but said that additional batches are still under review and that it will communicate the results when those are completed.
The FDA emphasised that it is not yet ready to include the Emergent BioSolutions plant in the Janssen emergency use authorisation (EUA) as an authorised manufacturing facility but said it continues to work through issues there with Janssen and Emergent management.
The decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 Vaccine means that doses made with this drug substance can be used in the US or exported to other countries. A condition on any export of these batches, or of vaccine manufactured from these batches, is that the FDA may share relevant information about the manufacture of the batches under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used. The FDA has also revised the letter of authorisation for the Janssen vaccine to help facilitate potential export to other countries.
Additionally, the FDA has extended the expiration dating for the refrigerated Janssen COVID-19 Vaccine. After reviewing information submitted by Janssen it determined that the vaccine can be stored at 2-8°C for 4.5 months instead of three months.