The announcement of the first fully-approved vaccines for COVID-19, the disease at the heart of probably the most pervasive pandemic the world has ever known, came as the proverbial light at the end of a long and particularly dark and death-filled tunnel. Pretty soon however, we learned those first ones (not counting Sputnik, the Russian contribution that presented a different set of problems) were not for everyone. We watched as the light eventually turned into a train, and then as it blew right by us. But it was hardly reason to be discouraged, because ours was on its way.
Those keeping up with the pandemic will clearly recognise the analogy to that first train being some of the fancier, state-of-the-art, yet also never- tried-before mRNA vaccines developed by Pfizer-BioNTech and Moderna, that some of the richer countries of the world were able to secure supplies of first, mostly thanks to their financial clout. As private sector companies, the makers were of course under no obligation to take part in any global public health initiative. Pfizer even avoided taking any funds on offer under Operation Warpspeed from the US government, that other companies including Moderna have gladly availed (Pfizer’s partners BioNTech, who developed the underlying technology, did take $400 million from the German government).
In the poorer parts of the world, we had to wait for the train marked Oxford-Astrazeneca, and fortunately that first name entered into the partnership on condition that there would be none of the profiteering that the pharmaceutical industry, or at least the clutch of global giants collectively known as ‘Big Pharma’, is notorious for. And we were comforted by the fact that although not the first ones to rescue our species from a stunningly penetrative and successful enemy, or even the most efficacious (its efficacy results from clinical trials have not only failed to match the designer vaccines being rolled out, even the presentation of the data was a bit iffy), it was at least for us – the closest thing to what can be called “the people’s vaccine’.
All of Moderna’s doses and 96% of Pfizer/BioNTech’s have been acquired by rich countries. In welcome contrast Oxford/AstraZeneca has pledged to provide 64% of their doses to people in developing countries. It is also the only approved vaccine which can be stored at fridge temperatures. However, despite their actions to scale up supply, they can still only reach 18% of the world’s population at most, in 2021. On January 4, the UK’s National Health Service again became the first health agency in the world to deploy ‘the Oxford vaccine’, as it has grown to be known, following another quick and prompt review and approval by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) ‘after meeting strict standards of safety, quality and effectiveness’.
That set the dominoes rolling and both India and Bangladesh soon followed, over the past week. India also approved, for emergency use, a homegrown vaccine by Bharat Biotech, an experienced Hyderabad-based company that enjoys a good reputation.
On the cusp
The Directorate General of Drug Administration (DGDA) in Dhaka issued the approval on Monday evening (January 4), with the emergency use proviso that most countries have used.
"We held a meeting with our vaccine expert committee this evening," said Brig Gen Mahbubur Rahman, director general of DGDA. "We reviewed all the reports on this vaccine, and then issued a no-objection certificate (NOC) on the emergency use of Oxford's Covid-19 vaccine in Bangladesh.”
Beximco Pharmaceuticals Ltd has collected the NOC from the DGDA, and using it, they can now begin the procedure to bring the vaccine from India, he further added.
Earlier on Monday, amid the confusion that India had barred export of Covid-19 vaccines until its local needs were met, Health Minister Zahid Maleque and Foreign Minister Dr AK Abdul Momen both said there was no need to worry.
Saying that Bangladesh would get the delivery of its vaccine shipment from India on time, the foreign minister said: "Decision has been taken at the highest level, and that will be implemented. Nobody has to worry or get panicked," he told reporters, sharing the updates Ministry of Foreign Affairs had received from the Indian Ministry of External Affairs.
Dr Momen said they had talked to the Indian External Affairs Ministry and the Indian High Commission in Dhaka once they had heard of a ban, reported our sister newsagency, UNB.
"Bangladesh must not be concerned as commitment has been made at the highest level. Nothing to worry," he added.
Beximco Pharma also made the assurance that the first shipment of Covid-19 vaccines from the Serum Institute of India (SII), with whom Beximco has signed a deal, would arrive on time.
“We hope to get the vaccine as per the agreement,” Beximco Pharma's Chief Operating Officer Rabbur Reza said on Monday. “We are in constant touch with them. We have spoken with Serum (Institute of India) even today. They have assured us,” he added.
Responding to a query on India barring export of vaccines, Reza said: “Serum Institute has already received requests for vaccines from some 70 countries. But they want to give priority to Bangladesh.”
The confusion didn’t have much meat to it, but nevertheless had risen on the back of a statement to the Associated Press by the CEO of the Serum Institute, in which he most likely misspoke. The next day, in a joint statement, Serum’s CEO Adar Poonawala and Bharat Biotech Chairman Dr Krishna Ella communicated their intent to develop, manufacture and supply Covid-19 vaccines for India and the world.
The statement said the more important task in front of them is saving lives and livelihoods of populations in India and the world. "Vaccines are a global public health good and they have the power to save lives and accelerate the return to economic normalcy at the earliest," it reads.
It said, "Now that two COVID-19 vaccines have been issued EUA (emergency use authorization) in India, the focus is on manufacturing, supply and distribution, such that populations that need it the most receive high quality, safe and efficacious vaccines. Both our companies are fully engaged in this activity and consider it our duty to the nation and the world at large to ensure a smooth rollout of vaccines. Each of our Companies continue their COVID-19 vaccines development activities as planned."
Earlier in the day, Adar Poonawala also specifically clarified that export of vaccines is permitted to all countries.
You could almost hear the sigh of relief across Bangladesh.
The man with a plan?
The COVID-19 vaccination program will start in Bangladesh at the end of January or the beginning of February, Health Minister Zahid Maleque said this week, speaking after the DGDA’s approval was reported.
As vaccinating millions of people across the country to control Covid-19 looks to be a daunting task, the government has prepared a masterplan and necessary guidelines to do the job properly, he said.
The masterplan will soon be submitted to Prime Minister Sheikh Hasina for approval to begin the country’s biggest-ever vaccination program in early 2021, said officials at the Ministry of Health.
In an interview with UNB, Health and Family Welfare Minister Zahid Maleque said they have a target of vaccinating around 55 million people over the course of the first year, depending on the availability of the vaccine.
February, with fingers crossed
Zahid Maleque said the government has already taken necessary preparations to ensure proper distribution of the vaccine among people based on priority and necessity.
He said they hope that the vaccine will be available in the country by the end of January or early February. “Once the approval process of the WHO and other organizations is completed, the work on vaccination will start in the country at the end of January or the beginning of February.”
However, an official at the ministry, wishing anonymity, said they are getting ready to start the Covid-19 vaccination program in early February as they may not receive it by January.
As per their plan, the health minister said three crore (30 million) doses of Oxford/AstraZeneca vaccine will reach the country in different phases by the next six months.
Maleque said the health sector has sincerely been working on all the procedures -- from signing contracts to the immunisation process.
He said the number of people they are going to vaccinate will be around 55 million. “It’ll take six months to collect and vaccinate three crore doses of the vaccine of Oxford/AstraZeneca.”
Besides, the minister said, the COVAX program led by the World Health Organization (WHO) and the Global Alliance for Vaccines and Immunisation or GAVI is supposed to start giving Bangladesh vaccines for around 40 million people or 20% of the population by May and June.
“We’ve already completed signing a deal and all other paper works to have the vaccines under the COVAX program. So, about 55 million of our people will come under the vaccination campaign by a year's time, or slightly more,” he added.
Maleque said they have made all the preparations for reaching their target of vaccinating 55 million people as early as possible. “Our expert teams are working on it properly. We also have adequate manpower to make it happen.”
Who may get it first?
The minister said a masterplan and guideline have been worked out as to how the vaccine will be given and to whom it will be given first.
He said they have already set priorities for the distribution of vaccine doses.
In the first phase, he said, healthcare sector workers, and members of various forces, media and government employees, will be vaccinated with the highest importance.
Who all are out?
Maleque said half of the total population of the country is under 25 years of age while 40% of people are under the age of 18. “They don’t need the vaccine at the early stage.”
In addition, the minister said, about three million pregnant women and patients with some other complex diseases will not be vaccinated.
The health minister said the vaccine doses will be collected from Oxford and COVAX will cover the maximum people who are primarily needed.
Storage and transport
The minister said they have taken steps for ensuring freezing facilities at the district-level hospitals for the storage of the vaccines at the required temperatures.
Besides, he said, the process of procuring cold boxes for the transportation of the vaccine is underway. “World-class labs have been set up in Bangladesh having the recognition of the WHO.”
Maleque said they have also prepared cold chains and procured cold boxes for storing the vaccine at a specific temperature.
‘No chance of chaos’
“A guideline has been made on how the vaccine will be distributed. There’s no chance of any kind of chaos in the distribution of vaccines as everything will be done in accordance with the guidelines we’ve prepared,” the minister said.
He said they have sufficient trained manpower to provide the vaccine. “The vaccine will be given by skilled manpower. We also have a plan to involve the private sector in providing the vaccine.”
Maleque said the government will continue the normal vaccination activities for other diseases alongside the coronavirus vaccine ones.
Contacted, Health Secretary Abdul Mannan said a masterplan has been worked out for carrying out the vaccination activities in a disciplined manner.
He said the masterplan will be presented to the Prime Minister soon for her approval. “Once it’s approved, the vaccination activities will be carried out accordingly.”
As per the deal with the Serum Institute of India, Mannan said Bangladesh will get 30 million doses of vaccine (5 million doses per month) in the next six months. In the first phase, he said 5 million vaccine doses will come and it will be given to 2.5 million people. He also said the government is in talks with some other companies in addition to AstraZeneca to procure the vaccine.
Replying to a question, he said a guideline is being prepared on the storage and distribution of the vaccine. “Vaccination will be carried out as per the guideline.”
Asked how many doctors, nurses and other manpower will be needed to distribute the vaccine, Mannan said they will give details about it later after the approval of the masterplan.
The machinery of government
There were more signs this week that the machinery of government was indeed being mobilised for a strong push towards eradicating the virus that has thrown the entire world off kelter for more than a year now. At its weekly meeting, the Executive Committee of the National Economic Council (Ecnec) approved the first revision of the Covid-19 Emergency Response and Pandemic Preparedness Project, raising its cost by Tk 5,659.07 crore - mainly for the procurement, preservation and distribution of Covid-19 vaccines.
Talking about the Covid-19 project, Member of the Planning Commission Abul Kalam Azad said that apart from procuring, preserving and distributing the Covid-19 vaccines, the other major project operations include installation of modern microbiology laboratories alongside PCR machines at 27 medical college and hospitals in the country.
Besides, RT-PCR kits, antigen kits and health safety kits will also be procured under the project alongside setting up Biosafety Level-3 Labs at IEDCR and Bangladesh Institute of Tropical and Infectious Diseases (BITID), Chattogram.
He said 10-bed Intensive Care Units (ICU) and 20-bed Isolation Units would be set up at 43 district Sadar hospitals under the project.
The other major project operations include setting up 10-bed ICU units at 10 medical college and hospitals and 5-bed ICU units at infectious disease hospitals in Dhaka and Chattogram, setting up 7 medical screening units at 5 port of entries, setting up infectious disease units at 27 medical college and hospitals, infection prevention and control units at 62 district hospitals, medical waste management plants at 10 medical college hospitals and 10 district hospitals, and installing central liquid medical oxygen system at 30 government hospitals.
According to the project factsheet provided by the Planning Commission, the project has been revised for inclusion of installation of Vaccine Testing Lab (WHO maturity level-3) through strengthening the National Control Laboratory of the Drug Administration, inclusion of recruitment of necessary manpower and trainings to check Covid-19, and also inclusion of US$ 100 million to be financed by Asian Infrastructure Investment Bank (AIIB) as co-lender with the World Bank and $500 million by the World Bank against the coronavirus vaccine procurement.
Azad said the government aims to give Covid-19 vaccines to around 13.76 crore people of the country. The people aged below 18 would not be brought under the vaccine coverage except for certain reasons.
Some Tk 4,236.43 crore will be spent on procuring, transporting, distributing the vaccines while the frontline workers like health workers, law enforcers, media personnel would get the vaccines on priority basis, he said.
The planning minister said the government will monitor the Covid-19 vaccine management round the clock to check irregularities in vaccine distribution.
Last year, Ecnec approved the original project with an estimated cost of only Tk 1127.52 crore, which has now gone up to Tk 6,786.59 crore in the second revision. So the cost has gone up nearly six-fold. Project costs going up after revision are of course nothing new in bangladesh. Only this time, it may just be worth it.