Sri Lanka’s drug regulator, crucial in these troubled times of the COVID-19 pandemic, continued to be buffeted by gale-force winds. ‘Not sacking’ but appointing fresh ‘experts’ to make vital decisions with regard to approving Sinopharm, the Chinese vaccine, and COVAXIN, the Indian vaccine, was the order of the week by the National Medicines Regulatory Authority [...]


Drug regulator in turmoil

Allegations of musical chairs with Expert Panel over Sinopharm & Bharat vaccines, but Acting Head says it’s expansion and not sacking

Sri Lanka’s drug regulator, crucial in these troubled times of the COVID-19 pandemic, continued to be buffeted by gale-force winds.

‘Not sacking’ but appointing fresh ‘experts’ to make vital decisions with regard to approving Sinopharm, the Chinese vaccine, and COVAXIN, the Indian vaccine, was the order of the week by the National Medicines Regulatory Authority (NMRA), many alleged.

Refuting these allegations, NMRA’s Acting Chairman Prof. Sisira Siribaddana said that there was only an expansion of the Panel of Experts and no removals, while three other new experts had also been requested to keep an eye out for the developments with regard to granting of emergency-use listing (EUL) for vaccines by the World Health Organization (WHO).

There was much confusion whether the community vaccination programme has been halted or not. Pic by Indika Handuwala

When asked about Sinopharm, he stressed that this vaccine would not be given to Sri Lankans until the WHO grants it EUL.

This came as there was much confusion whether the community vaccination programme has been halted or not, with contradictory views being expressed by politicians and officials.

Sources told the Sunday Times that Acting Chairman Prof. Siribaddana was attempting to cobble together expert panels to give the nod for the Chinese vaccine (produced by the state-owned China National Pharmaceutical Group known as Sinopharm) and COVAXIN (produced by the Indian biotechnology company, Bharat Biotech).

The Sunday Times understands that a heated conversation emerged on email on attempts to appoint a new ‘expert group’ and the NMRA’s Acting Chairman gave less than six hours on Monday (March 29) to the Board Members to indicate “whether they have any strong objections” to the appointment of the new experts.

The earlier eight-member Panel of Experts on COVID-19 vaccines which has not refused approval to Sinopharm, only asked for more data, comprises senior clinicians Dr. LakKumar Fernando (a Paediatrician) & Dr. Ananda Wijewickrama (a Physician); senior vaccinologists Dr. Rajiva de Silva & Dr. Kanthi Nanayakkara; renowned immunologist Prof. Neelika Malavige; a senior Professor in Pulmonology Prof. Channa Ranasinghe; a respected medical statistician Prof. A. Pathmeswaran; and a senior epidemiologist Dr. Hasitha Tissera.

This panel had recommended that the NMRA should not approve Sinopharm for administration to Sri Lankans until more data on safety and efficacy are available.

Sources said the suggested experts to replace this panel are a Professor of Medicine; the Dean of Health of a private institute of higher education; and a senior Paediatrician as well as five Epidemiologists from the Epidemiology Unit. There was no confirmation whether these experts, who are expected to assess the safety and efficacy of the Sinopharm vaccine, have accepted the offer made by the NMRA’s Acting Chairman.

The Sunday Times, meanwhile, learns that strong objections ensued on Tuesday (March 30) when alleged attempts were made to “mislead” the Health Ministry’s National Advisory Committee on Communicable Diseases (NACCD) that the NMRA has “approved” the Sinopharm vaccine under ‘emergency-use authorization’ for use in Sri Lankans. The NACCD is the country’s highest technical committee on vaccinations which decides on the immunization policy.

Finally, the NACCD had been made to understand that the NMRA has given only a ‘waiver of registration’ to import the donation of the Sinopharm vaccine to the country, but had made a decision that more data on safety and efficacy are necessary to approve it for use on Sri Lankans.

China donated 600,000 doses of Sinopharm, which arrived in the country on Wednesday (March 31).

So far, the eight-member Expert Panel has granted EUL for AstraZeneca’s COVISHIELD and Russia’s Sputnik-V.

Give more data, was the same urgent call that went out from the WHO, with the decision on EUL expected from the WHO for Sinopharm initially in February, then early March or late March 2021, being put back now to late April.

This week, the WHO stated that an interim analysis of clinical trial data from two Chinese COVID-19 vaccines, Sinovac and Sinopharm, showed that the vaccines were safe and had good efficacy but “both vaccines lacked data in older age groups and in persons with co-morbidities”.

The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) which reviewed the applications of the vaccines has said it would hold off on issuing recommendations for how the two Chinese vaccines should best be used until after another expert panel rules on their EUL applications. A final decision would be made at the end of April.

The view in health circles was that China has given COVID-19 vaccines in the guise of donations, so that the receiving countries are required to register these vaccines. This is what they have done in more than 50 countries. After that, the sale of these vaccines would begin to those countries, possibly at around US$ 19 per dose. This was nearly four times the price paid for the AstraZeneca vaccine which is US$ 5.25.

Strong cautioning by SLMA & AMS

The Sri Lanka Medical Association (SLMA) has written to the Health Minister on Friday on the urgent need to ensure the approval of the NMRA prior to the use of any vaccine on Sri Lankan nationals.

Emphasizing the need to maintain the integrity and independence of the NMRA for a long-term successful vaccination programme in Sri Lanka, the SLMA stresses that the NMRA plays an essential role in protecting public health by ensuring medical products available in the country meet accepted standards of safety, quality and efficacy.

The SLMA states: “In the context of COVID-19, the NMRA appointed an independent panel of experts to study all documents submitted in relation to candidate vaccines for COVID-19 and provide scientific advice for emergency use approval in Sri Lanka. We understand that the recently imported Sinopharm vaccine to date does not have the NMRA approval for use on Sri Lankan nationals or the approval of the WHO.

“We are aware that the NMRA-appointed independent panel of experts were of the opinion that the data provided so far are inadequate to arrive at a decision on the safety, efficacy and the immunogenicity of the Sinopharm vaccine. We have been reliably informed that attempts are being made to overturn that decision and register the said vaccine for emergency use.

“The fact that a large consignment of the questionable vaccine has already landed in the country does support this information. We believe that it is irregular for our health authorities to administer a vaccine not approved by the NMRA even to foreign nationals based in Sri Lanka.

“We wish to emphasize to the government, the need to make decisions based only on scientific evidence for optimum control of the COVID-19 infection. Assuring a background of freedom for decision making at the NMRA with no other outside influence would be of paramount importance in this regard.”

Meanwhile, the Association of Medical Specialists (AMS) this week stated that despite a clear recommendation of a properly constituted independent expert advisory panel “we are concerned about reports that a newly-reconstituted Board of the NMRA appears to have taken an unprecedented step to disregard the panel’s opinion and allowed the import of the vaccine (Sinopharm) to be used in Sri Lanka.

“We also note with great anxiety and dismay of certain arbitrary appointments and removals being made to the NMRA Board. We strongly believe such moves as an attempt to undermine the scientific basis of vaccine approval and hence its safety, efficacy and acceptance by the public”.

The AMS added that it is a strong advocate for a careful, timely and transparent review of candidate vaccines by the NMRA with the support of relevant experts. The first step towards this is to ensure that the independence of the NMRA is maintained.

Sinopharm for Chinese workersThe Sinopharm vaccine will be administered to Chinese workers in Colombo, Puttalam, Kandy and Hambantota, starting tomorrow, Chief Epidemiologist Dr. Sudath Samaraweera told the media on Thursday.The people of Sri Lanka would be given Sinopharm, based on the decision of the Expert Panel, he said, adding that a request has been sent to get Sputnik-V and “when we get it, we’ll give it”.

When asked, the Deputy Director-General (Public Health Services II), Dr. Susie Perera said that the second dose for whoever has got the vaccine up to now would be in 12 weeks from the day the jab was given.

Conceding that there is a short supply of vaccines globally, she said that no decision has been made yet to give the Sinopharm vaccine to Sri Lankans.

“Due to the short supply of doses, the WHO has informed all member-countries that there will be a delay in the supply. We are aware that what we are getting from COVAX is going to get delayed and similarly, whatever countries that have come to bilateral agreements are facing a delay. What we are sure is that getting (the vaccine) through COVAX might be faster than getting through various bilateral arrangements. We are confident that through COVAX, we will be getting some supply. In whatever order that we gave the vaccines, we will be giving the second dose,” said Dr. Perera.

Asked when the next stock of vaccines is due, she said: “We were supposed to get it in April, but we know that we will be getting it in May. We have a stock that we can use to start giving the second dose. We won’t be mixing two different vaccines for the doses either.”

The Deputy Director-General (Public Health Services I), Dr. S.M. Arnold said that a vaccination plan is in place but the supply has been delayed. “Don’t panic, you will get the vaccine,” was his message to the public.

Beware of fake vaccines – WHO DG

With countries scrambling to secure COVID-19 vaccines, the World Health Organization (WHO) has warned against falling victim to fake vaccines.

“The WHO is concerned about the potential for criminal groups to exploit the huge global unmet demand for vaccines. We urge all people not to buy vaccines outside government-run vaccination programmes. Any vaccine bought outside these programmes may be substandard or falsified, with the potential to cause serious harm,” warned Director-General Dr. Tedros Adhanom Ghebreyesus.

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