Even if permitted, local vaccines will take 5 months to hit stores

The government is working on producing Chinese and Russian vaccines locally apart from buying doses, but those vaccines will not hit the stores before four-five months.

Companies capable of producing vaccines here and experts say the whole process of producing vaccines involves several phases, which will take time.

From getting the approval to produce a vaccine and then signing agreement with the parent company, the actual production process depends on technology transfer and validation, importing testing reagents, setting manufacturing procedure, and sterility check.

Pharmaceutical companies say all these phases will take time and some of the steps do not have any shortcuts.

Dr Firdausi Qadri, emeritus scientist at icddr,b, told The Business Standard even if a local company gets approval to produce a vaccine, everything, except for manpower and machinery, has to be imported.

"Even producing a simple medicine takes months. Producing vaccines is harder than drugs. It is not possible to produce vaccines in less than four to five months," she said. 

"It is a problem for us that we have not yet received the World Health Organisation prequalification from the National Regulatory Authority despite the approval and agreement. The United Nations Children's Emergency Fund (Unicef) will not buy the vaccine unless it is a prequalified one and the vaccine cannot be produced outside the country either," she added.

Three pharmas assessed

The health ministry has assessed the capabilities of Incepta Pharmaceuticals, Popular Pharmaceuticals, and Healthcare Pharmaceuticals to produce vaccines. These companies have vaccine production plants in the country.

Incepta, which was found to have the highest capability, will be able to produce China's Sinopharm vaccine through master seed and fill finish. The two others will be able to do so through bulk fill finish.

"No matter what process we choose, it will take time," said Abdul Muktadir, chairman of Incepta Pharmaceuticals.

"The company that gets approval has to sign an agreement with the parent firm. After that it will depend on at what stage the parent company will allow production from and how long it will take for technology transfer and imports."

The World Health Organisation (WHO) says the surge in infection has put global vaccine supply in jeopardy, leading to a shortfall of 190 million doses to global platform COVAX by June.

COVAX has so far delivered 65 million doses to 124 countries and economies. The WHO has called upon vaccine makers to make forward deliveries and supply additional doses to COVAX honouring their own commitments.

"And we need the large vaccine manufacturers to enter into deals with companies like Teva, Incepta, Biolyse and others who are willing to use their facilities to produce COVID-19 vaccines," WHO Director-General Dr Tedros Adhanom Ghebreyesus said at a media briefing on 17 May.

Time consuming process

Companies say it will take some time to import and produce vaccines even if it is done through fill finish after approval and deal signing are done.

A senior official at a company capable of producing vaccines said the manufacturing process involves many tests to be done through a standard procedure.

"We need the technology from the parent company, and we have to understand how to use it here. The technology also has to be validated."

Explaining further, he said, "Once a product is made, how it is made in the same way the next time is called validation. The same product has to be made several times for validation and that is the standard guidelines."

"All the data must be submitted to the drug administration before the vaccine can be produced. They will analyse everything. After that, if the process is right, we have to meet the final requirement and buy the equipment, including vials. There is also a process to buy those," he added.

The official said producing vaccines through fill finish is also time-consuming as the product has to be brought after completing all the processes. 

"Requisitions will be sent for purchase. Products will come from one country to another. A vaccine has to be stored for 14 days after it is made. Then comes the sterility check. It will take at least another 14 days. There is no shortcut here. The whole process will take four to five months."

"It is not a matter of importing something and filling up bottles. It is medicine and it will take time," he added.

Apart from the three companies, Renata and Orion Pharma have also sought permission to produce vaccines. They also said it would not be possible for them to go into vaccine production before six to seven months.

The chief executive of a company that sought permission to produce the Russian vaccine said it would take at least six months to market the product after getting approval.

On condition of anonymity, he said after getting approval, raw materials have to be imported by signing a contract and those have to be produced locally then.

"Importing raw materials through a letter of credit (LC), unloading those at port, transporting those to the plant, and processing those will take time. It may take six to seven months to bring the product to market after testing."

He added, "But as we do not lack machinery and manpower, some are hoping the approval will be given fast and it will take a shorter time to market the product."

Prof Sayedur Rahman, chairman of the pharmacology department at Bangabandhu Sheikh Mujib Medical University, told The Business Standard the fill finish process might be conducted before vaccine is produced in Bangladesh and that would include importing vials.

"It takes three days to fill the vials with the vaccine that is produced in 30 days. This is time-consuming. It is done with robots abroad but here we will do it through automation." 

On Monday, Health Minister Zahid Maleque said companies would have to secure the drug administration's approval for producing vaccines.

"The drug administration will assess and recommend some names. One or more companies from those may be given the final approval then. No company has yet been given the approval. Despite a company's capability, producing vaccines locally will take four to five months."

Vaccination drive in uncertainty

The nationwide vaccination drive started on 7 February with the Oxford-AstraZeneca vaccine produced at the Serum Institute of India. The second dose of vaccination began on 8 April. However, administering the first dose was suspended from 26 April because of the vaccine shortage created by India stopping all vaccine exports.

As per the deal with Serum Institute and Beximco, the government was supposed to get 50 lakh doses of Oxford-AstraZeneca vaccine every month. It has so far received 70 lakh doses in two shipments. It now has only 6.23 lakh doses out of 1.2 crore.

The second dose for 14 lakh people is still uncertain as India did not confirm when the next consignment would arrive in Dhaka.

Due to the vaccine crisis, the second dose also has already been suspended at various vaccination centres across the country. Vaccination can be carried out for six more days with the available doses. There is uncertainty over when more vaccines will arrive so that vaccination can go ahead in full swing.

Dr ASM Alamgir, principal scientific officer at the Institute of Epidemiology Disease Control and Research (IEDCR) and a member of the Covid-19 vaccination core committee, said, "We are disheartened that such a well-managed vaccination programme has suddenly come to a halt due to vaccine shortage."

"We are contacting different countries to get vaccines. We hope to get vaccines soon," he added.