Who should approve the use of the J&J vaccine?
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DURBAN - UNCERTAINTY has erupted regarding the authorisation for the use of the Johnson and Johnson (J&J) Covid-19 vaccine as teachers were expected to start getting vaccinated on Wednesday.
On Tuesday, during a media briefing, Health Minister Dr Zweli Mkhize, who had visited the Northern Cape and did a walkabout of some of the vaccination sites, said they needed the South African Health Products Regulatory Authority (Sahpra) to tell them that:
– They had discussions with the United States Food and Drug Administration (FDA) and European Medical Agency;
– They have analysed their reports; and
– They are comfortable with the fact that the vaccine can be used and the Health Department would be ready to use the vaccines.
“The vaccines are there, they are waiting for the past month-and-a-half, they are sitting there. It is not the manufacturer that authorises the use, it is the regulator. We must allow the regulator to deal with the issue from their point of view,” explained Mkhize.
He had called a meeting with Sahpra and J&J and it was then decided that a meeting must be held with the US FDA (United States Food and Drug Administration) and Sahpra because they were the regulators. “They must clear their issues and release the vaccines.”
On Monday, the Sahpra said nearly all vaccines used in South Africa were manufactured in other countries, and Sahpra required documentation that confirmed the quality of these vaccines from the regulatory authority in the country of manufacture.
Through an arrangement called reliance, Sahpra has formal relationships with certain regulatory authorities that allow for the confidential exchange of information. For vaccine approvals, this allows Sahpra to access reports produced by other regulatory agencies on inspections, testing and various other aspects of manufacturing and testing compliance.
Sahpra has such a reliance arrangement with the US FDA. In addition, Sahpra relied on lot release testing undertaken by these partnering agencies which involved reviewing manufacturing documentation and performing certain quality tests to ensure compliance with the approved and registered requirements.
Sahpra said a concern was identified by the FDA relating to non-compliance to Good Manufacturing Practices (GMP) at the Emergent plant in Baltimore, USA, during the manufacturing of some active pharmaceutical ingredient used in the Janssen Covid-19 vaccine.
The non-compliant batch has been rejected; however, the incident has led to the investigation of four more batches by the US FDA, and Sahpra is awaiting reports from the US FDA on whether or not these other batches were manufactured according to GMP standards and if the batches are contaminated.
Until the FDA has shared these reports, Sahpra has insufficient information to approve specific batches of the J&J Covid-19 vaccine.
Sahpra CEO Dr Boitumelo Semete-Makokotlela said: “Sahpra is in continuous discussion with the US FDA to ensure that this matter is resolved speedily. Sahpra will take all the necessary steps to ensure that the vaccines that are administered to South Africans meet all the requisite stringent standards so that the health and well being of all who live in South Africa are not compromised in any way.”
The World Health Organization (WHO) said this week that South Africa does not need approval from the FDA in the US before it can begin administering the J&J vaccine to citizens as it was on the emergency use list.
Assistant director-general for Access to Medicines, Vaccines and Pharmaceuticals Mariangela Simao said on Monday that the vaccine itself has received an emergency use listing from the WHO.
“South Africa does not rely on the FDA approval to use it, and South Africa, I believe, has the emergency use authorisation to use (it),” said Simao during a press conference.
During the “family meeting” over a week ago, President Cyril Ramaphosa had said the delivery of J&J vaccines were delayed due to regulatory issues related to the lack of adherence to proper standards at a manufacturing plant in the US.
Ramaphosa said they were waiting for the issues to be resolved before the first batch of J&J vaccines could be released from the facility in Gqeberha in the Eastern Cape.
“While this is a challenge that has affected the supply of vaccines for many countries and not just in our country, we are in constant contact with the relevant authorities to ensure that our doses can be released as soon as possible,” said Ramaphosa.
“When the J&J vaccine has been cleared, it will be much easier to administer. It is a single dose vaccine and can be stored in a normal fridge.” | Additional reporting by Jehran Naidoo (ANA)