Regulator seeks more data on Sinopharm and Sputnik V jabs

• No definitive information on expected COVID-19 vaccine quantities and timeframe
• NMRA still analysing data on other COVID vaccines, SPC in discussion with Pfizer
• Priority groups to be decided based on quantity of vaccines received
• Govt. may permit private sector distribution of vaccine in future

By Shailendree Wickrama Adittiya

Despite the imminent possibility of Sinopharm vaccines arriving in the country, Health Authorities yesterday stated they were still awaiting more data on both the aforementioned and Sputnik V COVID-19 vaccines before giving regulatory approvals.

At a press briefing held yesterday on COVID-19 vaccination, Senior Consultant Physician of the Infectious Diseases Hospital and member of the expert committee appointed by the National Medicines Regulatory Authority (NMRA) on COVID-19 vaccines Dr. Ananda Wijewickrama said, that the vaccines will be approved by the NMRA if they are deemed suitable for use in the country and are produced in accordance with World Health Organisation (WHO) recommendations and standards.

“Applications for registration have been submitted to the NMRA for the Sinopharm and Sputnik V vaccines. The appointed committee analysed the data on these two vaccines. We require more data and have informed the relevant organisations to provide the data as soon as possible,” Dr. Wijewickrama, the first healthcare professional to receive the Oxford-AstraZeneca vaccine in Sri Lanka, said.

He added that the NMRA has also analysed data on the Pfizer vaccine. 

“We have decided it is a good vaccine. However, the only issue with the vaccine is that due to orders from other countries, supply will be a problem,” he went on to say. Despite this, the State Pharmaceutical Corporation (SPC) is holding discussions with Pfizer.

Deputy Director General of Health Services Dr. Hemantha Herath explained they were expecting the first batch of vaccines through the COVAX facility for 20% of the population this month. 

“From the information we have received officially, by the end of February, we are to receive these supplies. A fixed date cannot be given as it depends on production and distribution,” he added.

Dr. Herath explained that approximately nine million persons need to be vaccinated in order to achieve the desired vaccine coverage in the country. The Government is thus also considering purchasing vaccines. 

“The Government has made all arrangements for us to purchase vaccines. Approximately nine million of the population is expected to be vaccinated and the Government hopes to import 18 million vaccination doses,” Dr. Herath said, adding that it will, however, take time to receive these orders due to the manufacturing and distribution process.

While Health Authorities were unable to give a definitive answer in terms of quantity and timeframes, Dr. Herath said all preparations have been made to begin vaccination as soon as the doses are received.

According to him, 4,000 centres have been identified as suitable for the COVID-19 immunisation program, with plans to have at least 2,000 centres running at a time. If a single centre vaccinates 300 persons a day, a total of 600,000 persons can be vaccinated in a day across the island.

This depends on the doses the country receives, however, and Dr. Herath stated that the first round of the ongoing immunisation program has administered the vaccine to most of the target group. A donation from the Government of India, the 500,000 doses of the Oxford-AstraZeneca COVID-19 vaccine will be provided to 250,000 frontline workers from health, military and police units.

Priority groups for the next campaign of vaccination will depend on the quantity of vaccines received. While Health Authorities previously stated that the process will target age groups starting from above 60 and moving on to the 50-59 group, 40-49 group and so on, they are now considering all those above 30 as a whole.

Priority will be given depending on risk factors like comorbidities, as well as contribution to the economy and exposure to the public. Teachers, for instance, have been identified as a priority group and media personnel may also be considered due to their exposure to the public.

With the ongoing campaign of immunisation, for instance, priority was given to frontline workers as the COVID-19 treatment and prevention system would collapse if frontline workers are affected.

Health Authorities also stressed that changes may be made to current policies and decisions on vaccination, depending on the vaccines the country receives as well as data on vaccinations. Dr. Wijewickrama explained that when the Oxford-AstraZeneca vaccine was first produced, it was recommended that the second dose should be administered after a four-week interval.

“However, data now shows efficacy increases when it is administered after 12 weeks and there is higher immunity than when giving the second dose in four weeks. Due to this, doctors are holding discussions and, while the decision currently is to administer the second dose in four weeks, there is a chance of it being administered after 12 weeks depending on data that surfaces,” he went on to say.

In response to a question on persons who have recovered from COVID-19 receiving the vaccine, Dr. Wijewickrama said the accepted policy in the world at present is to provide the vaccine even to persons who have already contracted the virus. This is the current WHO recommendation as well.

In terms of procuring, distributing and administering, the State sector will continue to handle the immunisation process for the time being. However, Dr. Herath said, “In the future, I believe this vaccine and any other vaccines the NMRA approves of can be administered through the private sector as well.”

At present, the vaccine will be administered at no charge to persons based on priority as opposed to those who can afford it, a situation that could change if the private sector is permitted to administer the vaccine. 

However, certain private sector institutions have shown interest in purchasing the vaccine to provide it to their employees and the possibility of this has been discussed with AstraZeneca and Pfizer. The developers and manufacturers, however, stand by the policy to not permit purchases by the private sector given insufficient supply to meet current vaccine demands.

“Thus, at present, even if a private company or individual wants to purchase the vaccine, they will not be able to because the manufacturers currently do not permit it,” Dr. Wijewickrama added.