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Bangladesh approves Russia’s Sputnik V Covid-19 vaccine for emergency use

  • Published at 01:59 pm April 27th, 2021
Sputnik V Vaccine
File Photo: Sputnik V gives around 92% protection against Covid-19, according to late-stage trial results published in the Lancet in February this year Reuters

Bangladesh expects to receive around 4 million doses next month, says the drug administration chief

The Directorate General of Drug Administration (DGDA) of Bangladesh has approved emergency use of Russia's Sputnik V vaccine, paving the way for a second Covid-19 vaccine in the country.

The decision comes at a time when the country is in desperate need of Covid-19 vaccine doses to ensure the continuation of the nationwide inoculation drive.

Sixty countries have so far approved the use of the two-dose vaccine, including Bangladesh. India approved it on April 12.

The health authorities in Bangladesh had stopped administering the first dose of the Oxford-AstraZeneca vaccine (Covishield) from Monday amid uncertainties over further shipments.

DGDA Director General Major General Md Mahbubur Rahman said the Russian vaccine had been approved to pave the way for its import, production and use in Bangladesh.

“We are expecting around four million vaccine doses to arrive in May,” he added.

The vaccine would be brought in under a government-to government (G2G) initiative, and a local manufacturer, possibly Incepta Pharmaceuticals, might produce it in Bangladesh in the future, the DGDA chief said.

“Only a handful of pharmaceutical companies, such as Incepta, Popular and Healthcare, have the facilities necessary to manufacture vaccines. Representatives from the Russian side will visit Bangladesh and evaluate the facilities,” he stated.

“The company which meets their requirement will produce the vaccine,” he said, before adding that the production method was still undecided.

Still awaiting WHO’s approval

Health Minister Zahid Maleque, at a press briefing on Tuesday, said the government had given the DGDA the green light to approve the vaccines accepted by WHO and other international drug regulators.

The approval of Chinese-made vaccines was under process as well, he said.

Meanwhile, WHO said it was still in discussions about Russia’s Sputnik V vaccine and had yet to set a date to evaluate the shot’s clinical data for a possible emergency use listing, as reported by Reuters.

"On Sputnik, we are still waiting, we are still in the back-and-forth stage. So we don't have a review meeting scheduled yet," WHO spokesperson Margaret Harris told a briefing in Geneva.

However, DGDA DG Maj Gen Mahbubur said another protocol had been followed to approve Sputnik V for emergency use.

A technical experts’ committee recommended that the vaccine be approved on Tuesday noon after reviewing all necessary documents and its efficacy. The emergency core vaccination committee under Prof Kamal of Bangabandhu Sheikh Mujib Medical University has given its nod as well.

The government formed the five-member technical experts’ committee on April 20 to send vaccine recommendations to the DGDA in a move to find alternatives to the Oxford-AstraZeneca one.

“The Sputnik V vaccine was approved at around 1pm on Tuesday following the committee’s recommendation as we had already evaluated it earlier,” the DGDA chief said.

Sputnik V is one of the Covid-19 vaccines that had an efficacy rate of over 91%, he added.

Can it be used as the second dose for Oxford vaccine recipients?

Like Covishield, the Oxford-AstraZeneca vaccine manufactured by Serum Institute of India, Sputnik V is also an adenovirus vaccine.

Asked if Sputnik V could be administered as the second dose to people who had received their first dose of Covishield since the country was running out of the latter, the DGDA DG said a committee had been formed to analyze that avenue.

However, the authorities were trying to administer the same vaccine as both doses to every recipient, he added.

Next course of action

Maj Gen Mahbubur Rahman said the hunt for another vaccine would continue despite the approval for Sputnik V.

“We are reviewing documents related to the Sinopharm jab,” he stated.

Health Minister Zahid Maleque, on the other hand, termed the attitude of global leaders in reserving more vaccines for developed countries “frustrating”, and said it was the reason why Bangladesh had not received an adequate amount of the Oxford-AstraZeneca vaccine even after paying for it in advance.

“We are exploring alternative sources now. All necessary documents of the Sinopharm vaccine have been sent to the authorities concerned … we are waiting to get the vaccine in hand,” he added.

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