As 2020 comes to a close and the world continues to battle with waves of Covid-19, a vaccine seems to be the only hope left to break this cycle. In the global race for a vaccine, the relentless dedication of the scientists has generated extraordinary results at an incredible speed. Three vaccines are on the verge of getting emergency use authorization and a total of 58 vaccines are in clinical trials on humans. Experts have cautioned that widespread vaccination programs will take a while, as approval and mass production takes time, but we can expect more options to become available by the middle of next year.
The US Food and Drug Administration has set the vaccine efficacy rate benchmark at 50%, which means any vaccine to get authorized will need to be safe, prevent disease, or decrease its severity in at least 50% of the people who are vaccinated. The top three front-runners in the vaccine race, Pfizer and BioNTech, Moderna, and Oxford-AstraZeneca have published their vaccine efficacy rate, and all are much higher than this benchmark. A vaccine having 90% to 95% efficacy rate during an outbreak condition is a well-proven safe bet for extensive use.
What are the most promising vaccine candidates?
The vaccine made by Pfizer and BioNTech is showing 52% efficacy within a week after the first dose and 95% after the second dose across people of all ages, races, and weight. Moderna reported their vaccine having a 94.5% efficacy rate after a late-stage trial. Both the vaccines require two standard doses per person, and both have applied for emergency use authorization from the US FDA, however, the UK has already started the Pfizer vaccine roll out by giving an emergency authorization. Pfizer gained permission early on and Moderna is seeking permission to test the vaccine on children between 12-18 years of age.
The Oxford-AstraZeneca vaccine is the third in the race. This vaccine has an efficacy of 90% with an initial half-strength dose followed by a full second dose, and the two standard-dose shots have 62% efficacy rate. All respondents between the ages of 18 to 70 produced similar levels of antibodies against the virus.
The other vaccines from around the world already in the second and third phase of trial and look promising are: Novavax, Johnson and Johnson, Imperial College London, Arcturus Therapeutics and Duke-NUS Medical School, Sanofi/GSK, Curevac, Sinovac, and Sinopharm vaccines.
What technologies are being used to manufacture the vaccines?
Pfizer and Moderna vaccines are made from messenger RNA technology which instructs human cells to make the coronavirus spike protein to induce an immune response.
The Oxford-AstraZeneca vaccine makes use of a genetically modified adenovirus derived from chimpanzees to carry a gene for the spike protein which, once taken up by human cells, stimulates the immune system to make antibodies and T-cells.
The AstraZeneca vaccine can be transported and stored at normal fridge temperatures. The Pfizer vaccine requires storing at minus 70 degrees Celsius from the manufacturing point till it is injected. The Moderna vaccine remains stable at minus 20C for up to six months, at refrigerated conditions for up to a month, and at room temperature for up to 12 hours.
The great news is, all these vaccines can be designed, developed, and tested much faster than traditional vaccines.
What about the Chinese and Russian vaccines?
According to an article in Nature magazine, five out of the 11 vaccines that are being developed in China are in phase 3 clinical trial. Two are being developed by state-owned enterprise Sinopharm, one by CanSino, one by Sinovac, and the fifth one by Anhui Zhifei Longcom Biologic Pharmacy. Sinopharm’s and other vaccines’ trials are being carried out in many countries like the UAE, Pakistan, Saudi Arabia, Indonesia, Brazil, and some others.
International regulators are yet to approve any Chinese vaccine yet, but their government gave emergency-use authorization to vaccinate high risk front-line medical staffs and other officials. By early November, nearly 1 million Chinese people were inoculated with the Sinopharm vaccines.
Russia reports 92% efficacy of their Sputnik V vaccine and has rolled out vaccination programs for their health care workers, teachers, and social workers. The late-stage testing is not completed yet, but emergency use was already given in August. Russian researchers claim that more than 50 countries have requested for more than 1.2 billion doses of the Sputnik vaccine. Bangladesh is in contact with both China and the Russia for Sinovac and Sputnik-V vaccines.
How many doses of vaccine does the world need?
Vaccine roll out has already begun, and all eyes are focused on the global manufacturing capacity since it will soon become a precious commodity. The world population stands at 7.8 billion and the WHO has put the Covid-19 herd immunity threshold at around 70%. That means we will need a total of 11 billion doses for inoculation. Estimated world capacity stands at around 10 billion doses by the end of 2021 -- that includes AstraZeneca’s 3 billion, Pfizer’s 1.3 billion, Moderna’s 1 billion, Russia’s Sputnik, and six other potential ones that are ready for production -- if they get the authorization.
Already, more than 10 billion vaccine doses have been pre-ordered and half of them are secured by Canada, the US, the UK, Australia, Japan, and the 27 EU countries which represents just 13% of the world population. Canada leads the pack by securing nine doses of vaccine per person and India secured 2 billion doses just by leveraging their access to the manufacturing capabilities of the Serum Institute of India.
This kind of vaccine nationalism makes it difficult for the low and middle-income countries to procure vaccines for their people. Anticipating this, COVAX was launched in April 2020 which is co-led by WHO, Gavi, the Vaccine Alliance, and the Coalition for Epidemic Preparedness Innovations (CEPI). COVAX works with vaccine manufacturers and has access to a large portfolio of vaccines, which includes Moderna and AstraZeneca shots.
Their aim is to provide equitable access to safe and effective vaccines for both high and low-income countries. They plan to raise $18 billion, secure and provide 2 billion doses by the end of 2021 to cover at least 20% of the population of participating countries. Bangladesh is one of the 189 countries which signed up with the COVAX facility.
What is Bangladesh’s strategy for procuring the vaccines?
Bangladesh signed an agreement with Serum Institute of India and Beximco Pharmaceuticals Ltd to collect 30 million doses of the AstraZeneca vaccine to vaccinate 15 million people in the first phase. We will also receive 68 million doses through COVAX. These should cover 29% of our population.
The government has approved direct Covid-19 vaccine procurement from any organization through negotiations without following a bidding process. Conditions apply -- these must be WHO or EU authorized vaccines, and the manufacturer will need a certification from DGHS. Through direct procurement and the COVAX initiative, Bangladesh will have a wider access to vaccines.
AstraZeneca priced their vaccines at $2–$3 per dose and promises to make no profit from its sale while the pandemic lasts. Pfizer’s vaccine will cost around $20 to $25 and Moderna’s one will be $37. The AstraZeneca vaccine is only costing $1.6 to $2 per dose for Bangladesh, thanks to the COVAX facility. There is a plan to purchase 40% of the needed vaccine through COVAX. Also, the less stringent storing condition makes this an ideal vaccine for Bangladesh.
Who are the biggest vaccine manufacturers?
By revenue, the world’s top five vaccine makers are from the US and Europe. By volume, India is the biggest as it supplies some 60% of the world’s vaccines, and Serum Institute of India is the biggest manufacturer of vaccines in the world. By capacity, China is the largest, even though only 5% of Chinese-made vaccines are sold abroad since their fragmented industry serving the domestic market has safety issues. However, China has joined COVAX and hopes to supply to developing countries when their vaccines get international authorization.
Do we have the infrastructure to store, distribute, and inoculate people?
Bangladesh is procuring AstraZeneca vaccines which can be stored in normal refrigerators. It will be essential to reduce potential hazards as the vaccine travels from the point of manufacturing to the point of delivery. Early planning of setting up vaccination points and the meticulous distribution process must address all logistical hurdles associated with the cold-chain maintenance. Last-mile cooling facilities, storage at vaccination points, and inoculation as the final delivery must be a smooth process for a successful vaccination program. This will require a large coordination effort, awareness, and skilled people handling the vaccines.
Countries gearing up to use the Pfizer vaccines have ramped up their cold storage capacity and delivery logistics in readiness for the vaccine roll-out. Investments are going in to make specialized freezers, dry ice, lithium battery, syringes supply, etc. Logistics companies UPS, FedEx, and DHL are also preparing for vaccine transportation. Any private initiative in Bangladesh would do well to keep these additional investments in mind while importing Pfizer or Moderna vaccines, since specialized ultra-cooling facilities will be needed to maintain cold chain at either minus 70 or minus 20 degrees Celsius, depending on the vaccine.
What is the strategy of choosing vaccine recipients?
The Strategic Advisory Group of Experts (SAGE) on Immunization of the WHO has devised a strategy that includes the principles of choosing the target groups of immunization once vaccines become available.
The five principles -- human well-being, equal respect, equity, reciprocity, and legitimacy will dictate the priority groups of people in need of vaccination.
At stage I, there will be enough vaccines to cover only 1–10% of the population. Then at stage II additional 11-20%, and then finally at stage III another 21-50% of the population will be covered.
Ultimately, the government will decide who will get immunization priority in the three stages. SAGE indicated the following groups should get precedence -- health care workers, older patients with elevated risks and comorbidities, law and order front-liners, public representatives, social workers employed in public service works, workers in non-essential but economically critical sectors who cannot maintain physical distancing, teachers, media workers/journalists, city corporation and municipal workers, government leaders/administrative/technical personnel critically needed for indispensable functions of the state, underserved people, and displaced people. Another group we may need to keep in mind are the people serving jail time.
As there is no trial study report published on the vaccine use in pregnant women, lactating mothers, and children, it is not recommended to be used in these groups. The Covid-19 recovered people are also recommended to take the vaccine, since antibodies wane after a few months of infection.
Transparency is needed in decision-making to avoid bias and for defending the decision.
What else should be done till we get a vaccine?
The government has finally approved and started the rapid antigen testing. Rapid antibody test will also be needed soon to conduct nationwide sero-surveillance to detect the number of people who have already had Covid-19. Once the vaccination begins, antibody tests will also be used to monitor the level of antibodies produced from the shots.
According to the CEO of the Serum Institute of India, it may take another four years for everyone in the world to be vaccinated. Vaccines will provide protection, but we need to be vigilant and observe if people can still get the disease after vaccination and if they do, then are they transmitting the disease or not.
Meanwhile, till the majority are vaccinated, social distancing protocols will remain essential, which include mandatory mask-wearing, avoiding indoor gathering, keeping three to six feet distance, limiting the exposure time at closed gatherings, meeting in open spaces, keeping indoors ventilated, and handwashing/sanitizing. An epidemiology and transmission study in India found that children and young adults who make up one-third of Covid-19 cases were key to transmitting the virus. So, keeping schools closed will remain a better option.
Once vaccination begins, we should be prepared to track side-effects arising from vaccination. Experts will need to analyze the vaccine safety for different groups of people and ensure that recipients taking the first shot must come back for the second dose. The government needs to educate the public about what to expect and for further reinforcement maybe design a vaccine tracker. The tracker can track people who will be receiving the dose, connect it to a helpline for adverse effect support, and send auto-reminders of second dose. We must remember that it is not the vaccine, but the vaccination program that saves people.
Dr Maliha Mannan Ahmed is the Founder and Executive Director of Organikare. She has an MBBS, MBA, and a Master’s in Health Care Leadership.