Bringing COVID-19 vaccine to the world; a race of prowess – Part 2

After a failed attempt to buy the German company Curevac so that it could obtain sole rights to the coronavirus vaccine, it tried unsuccessfully to secure the first doses of a vaccine by investing 30 million dollars in the French pharmaceutical company, Sanofi.

Some countries can afford to buy access to vaccines leaving poor nations at risk. This oxygen mask approach by rich nations does not guarantee the safety of everyone because the pandemic does not identify national barriers. Therefore, the global health watchdog aims to equitably deliver two billion doses of safe, effective vaccines to both high- and low-income countries. The costs of producing a vaccine can range from 150 million dollars if the researchers develop a vaccine that is safe and efficient, early in the process.

If they have to keep going back to the drawing table, the costs of vaccine development become higher surpassing a billion dollars. The price of the vaccine is the final, negotiated price between the vaccine manufacturers and governments. The cost can be excessive in high-income countries but up to 400 percent lower in low-income countries. The World Health Organisation does not have enough finances to fund vaccine development. If it did, it would have ownership and power to ensure equitable distribution. There are financial risks involved in the research and development of a vaccine. If after all the extensive testing of vaccines, they are not approved, pharmaceutical companies would incur financial losses. Therefore, it is prudent to collaborate with other organisations and countries to pool financial resources together. It is in light of these that the 194-member health body partnered with The Global Alliance for Vaccines (GAVI) and Coalition for Epidemic Preparedness Innovations (CEPI) to form COVID-19 Vaccine Global Access (COVAX).

A laboratory technicians handles vials as part of filling and packaging tests for the large-scale production and supply of the University of Oxfordís COVID-19 vaccine candidate, AZD1222, conducted on a high-performance aseptic vial filling line on September 11, 2020 at the Italian biologicsí manufacturing facility of multinational corporation Catalent in Anagni, southeast of Rome, during the COVID-19 infection, caused by the novel coronavirus. – Catalent Biologicsí manufacturing facility in Anagni, Italy will serve as the launch facility for the large-scale production and supply of the University of Oxfordís Covid-19 vaccine candidate, AZD1222, providing large-scale vial filling and packaging to British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca. (Photo by Vincenzo PINTO / AFP)

Under COVAX, 34 candidate vaccines are in different stages of clinical trials and about eight are in the third phase of the clinical trials. One hundred and forty-two candidate vaccines are under preclinical evaluation. Despite many countries including the traditional USA allies; Germany, United Kingdom, and France, joining the COVAX initiative, the USA has decided not to join and has chosen to go solo citing the WHO as being China-centric.

Earlier in July, the USA initiated a formal pulling out from the WHO. The USA could have opted to join COVAX and still continue on its own solo vaccine development as some countries have done. The manufacture of a vaccine is a collaborative effort that entails countries, pharmaceutical firms, universities, public health agencies, research agencies, non-governmental organisations and the WHO. Under normal circumstances, vaccine development takes years but because of the ongoing pandemic, systems have been put in place to reduce the red tape that would have made it almost impossible for a vaccine to be ready within a year.

Pre-COVID era, candidate vaccines must go through the first three phases of clinical trials before they can be sold or administered to the public. When a vaccine is undergoing a clinical trial, it is called a candidate vaccine. Candidate vaccines usually go through four phases in the clinical trials. There are some steps that cannot or should not be reduced. These are the steps or stages of clinical trial of the vaccine. Before it gets to the clinical trial stage, the candidate vaccine must have passed through the pre-clinical stage. The clinical trial only starts after it has passed through a pre-clinical trial. At the pre-clinical trial stage, the vaccine is tested on animals and in the laboratory to see if the vaccine can elicit an immune response.

If the vaccine passes the pre-clinical phase, it can enter the Phase I with about 20-80 volunteers to test the safety of the drug. In a bid to fast-track some stages of the clinical trial, two different phases are being carried out concurrently. The Phase II tests for the efficacy of about 100-300 volunteers. It determines if the vaccine can actually elicit an immune response. The volunteers are usually divided into the control and test groups that will be given the vaccine. Phase III is tested on about 10,000-50,000 volunteers for safety and side effects. The group is also divided into control and test groups. Phase III participants must be followed up for several months or years.

In Phase III trials, participants are selected from areas where the risk of infection is high. Phase III trials are usually the nemesis of drug companies because of the large body of data they have to collect, collate, and analyze. They rely heavily on massive data collection and a combination of results from scores of hospitals and thousands of participants sometimes across different countries. Phase III wants to know as many side effects as possible that might not be visible in smaller groups. The United Arab Emirates and Saudi Arabia have agreed to have Phase III trials of Sputnic V conducted in their countries. Chinese-owned COVID-19 candidate vaccines are undergoing Phase III trials. The candidate vaccines are being tested on populations in Bahrain, the United Arab Emirates, and Brazil. Since thousands of people need to be tested in Phase III to prove efficacy before they can secure approval from regulatory bodies, China had to seek participants outside their country because COVID-19 is relatively under control in China unlike Brazil but Brazil has only agreed to test only its health care workers because they are constantly exposed. Even so, their workers wear personal protective equipment so one would have to wait and see if they can get a sizeable test group. By the 7th of September, Brazil ranked third in the number of COVID-19 cases. For several weeks, Brazil had been ranking second in the world before it was overtaken by India on the 6th of September.

The USA ranks first in the number of COVID-19 cases. The United Arab Emirates has relatively few infections so it might be a challenge for China to get a sizeable test population. Earlier, in a race against time, China had approved vaccine use for its military before completing phase III trials. AstraZeneca, a British firm in collaboration with the University of Oxford is also carrying out Phase III trials in South Africa, Brazil, and the United Kingdom. Moderna, a biotech company based in Massachusetts is testing its candidate vaccine on 30,000 people across the USA. BioNTech, a German-based company in collaboration with the New-York based Pfizer are conducting its Phase III clinical trials in 39 states across the USA and some countries including Germany, Brazil, and Argentina.

The Phase III is usually carried out in populations that have a high chance of getting infected with the disease. In addition, the country or location for the third phase of the clinical trial must have proper infrastructure on the ground to quickly detect and monitor side effects. In April, two French personalities on live television suggested that vaccines should be tried in Africa riling even the Director-General of WHO, Tedros Adhanom Ghebreyesus who hails from Ethiopia. The Phase IV is conducted after the vaccine has achieved regulatory approval and investigates the long-term effects of the vaccine and rare side effects. Some but not all experimental vaccines against SARS actually made the disease worse after the recipient was vaccinated. This usually occurs from vaccines made from inactivated viruses.
To be continued tomorrow.