2021: The Year of the Vaccine

By Ms. Pinja Mann, Analyst at IB Consultancy

As we start the new year, hopes of getting back to a somewhat normal state of affairs are starting to materialize, albeit slowly. The latter part of 2020 was full of setbacks on trials, issues on the supply-and-demand sector, coupled with poor coordination from governments and implementation of the actual vaccine Programs at large, making the roll-out for the COVID-19 vaccines in the beginning of the new year slow at best. Key international players are racing against the clock to facilitate the growing demand for the vaccines to contain the virus, which has mutated into an even more infectious strand. Japan and South America have also reported detecting new strains, distinct from the strains first reported in the UK and South Africa. Nevertheless, despite the growing concern over the vaccines’ effectiveness against the mutated virus, Pfizer/BioNTech vaccine makers are reportedly encouraged by a recent study showing that their vaccine appears to work against variants. However, the more time it takes to vaccinate at least 70 percent of each country’s population - a projection percentage for herd immunity - the more likely it is for the virus to mutate even further, making the current vaccines in the market void and ineffective. By the current rate, we are looking at the end of 2022 before all countries affected will have vaccinated the majority of their population.

Multiple agencies in the US and abroad have also launched various COVID-19 initiatives in a quest to fast-track vaccine developments. These include Operation Warp Speed (OWS), a collaboration of several US government departments, e.g., Health and Human Services and subagencies Defence, Agriculture, Energy and Veterans Affairs, and the private sector. OWS has funded JNJ-78436735 (Janssen), mRNA-1273 (Moderna), and NVXCoV2373 (Novavax), V590 (Merck/IAVI), V591 (Merck/Themis), AZD1222 (AstraZeneca/University of Oxford), and the candidate developed by Sanofi and GlaxoSmithKline. Within OWS, the US National Institutes of Health (NIH) has partnered with more than 18 biopharmaceutical companies in an initiative called ACTIV. ACTIV aims to fast-track the development of drug and vaccine candidates for COVID-19. Whereas the COVID-19 Prevention Trials Network combines clinical trial networks funded by the National Institute of Allergy and Infectious Diseases (NIAID): the HIV Vaccine Trials Network (HVTN), HIV Prevention Trials Network (HPTN), Infectious Diseases Clinical Research Consortium (IDCRC), and the AIDS Clinical Trials Group. Finally, the COVAX initiative, part of the World Health Organization’s (WHO) Access to COVID-19 Tools (ACT) Accelerator, is being spearheaded by the Coalition for Epidemic Preparedness Innovations (CEPI); Gavi, the Vaccine Alliance; and WHO. The aim is to work with vaccine manufacturers to offer global, equitable access to COVID-19 vaccines, so that 2 billion doses can be fairly distributed by the end of 2021. The COVAX initiative includes global companies as well as universities, namely Inovio, Moderna, CureVac, Institut Pasteur/Merck/Themis, AstraZeneca/University of Oxford, Novavax, University of Hong Kong, Clover Biopharmaceuticals, and University of Queensland/CSL.

According to the COVID-19 vaccine tracker, Regulatory Affairs Professionals Society (RAPS), a neutral, non-lobbying non-profit global organization, there are currently nine authorized and approved COVID-19 vaccines, namely the multinational mRNA-based vaccine, Comirnaty, developed by Pfizer, BionTech; Fosun Pharma. Comirnaty has been approved for emergency use (regulators allowing shots to be given to a certain group of people, e.g., health care workers, first responders or the elderly) in the UK, Bahrain, Canada, Mexico, the US, Singapore, Chile, Oman, Saudi Arabia, Kuwait, and the EU. While mRNA-1273, developed by Moderna, Biomedical Advanced Research and Development Authority (BARDA), and NIAID, has gained authorization in the US, Canada, EU, and Israel. While AstraZeneca, funded by CEPI, the UK Government, BARDA, Gavi, and the Vaccine Alliance is approved for use in the UK, India, Argentina, Dominican Republic, El Salvador, Mexico, and Morocco.

Currently, China and Russia have multiple vaccines for the global marketplace, three and two respectively. The Chinese Sinovac has developed an inactivated vaccine, composed of dead or inactivated viruses or bacteria, (formalin with alum adjuvant), CoronaVac. CoronaVac has been granted emergency use in China, and temporary authorization for emergency use in Brazil; whereas Indonesia granted emergency use approval earlier in January 2021. Beijing Institute of Biological Products; China National Pharmaceutical Group, Sinopharm has produced an inactivated vaccine by the name of BBIBP-CorV. The BBIBP-CorV is currently authorized for use in China, UAE, Bahrain, and Egypt. The third vaccine is also an inactivated vaccine, developed by Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm); its use is currently not authorized outside of China. Whereas the Gamaleya Research Institute, Acellena Contract Drug Research and Development in Russia developed the Sputnik V vaccine, a non-replicating viral vector (viral vectors are genetically modified to make replication-defective). Additionally, the Federal Budgetary Research Institution State Research Center of Virology and Biotechnology has developed a peptide vaccine, named EpiVacCorona; it’s currently only authorized in Russia. Meanwhile, Indian based Bharat Biotech, ICMR has developed an inactivated Covaxin vaccine, although it’s only approved for use in India.

In late December, Chinese authorities gave conditional approval for general public use of the Sinopharm’s, a state-owned drug-maker, COVID-19 vaccine. UAE and Bahrain have already granted the vaccine’s emergency use for their key workers earlier in December 2020. Turkey has also begun its massive vaccination campaign, using the Chinese Sinopharm COVID-19 vaccine. Turkey will reportedly also buy 30 million doses of another vaccine developed by German-based biotech firm BioNTech. In more recent developments, Brazilian researchers confirmed the effectiveness, 50.4 percent, of another Chinese vaccine, CoronaVac, developed by the Beijing based Sinovac, breaching the supply-and-demand gap left by the Western world. Sinovac has already sold more than 300 million doses, mostly to low-and middle-income countries. At present, several Southeast Asian countries, e.g., Vietnam, Malaysia, and the Philippines hope to finalize deals with Sinovac, despite limited data and the vaccine’s actual effectiveness to date. In addition to Sinovac purchases, Malaysia signed an additional deal to buy 12.2 million doses of Pfizer/BioNTech vaccine, according to the country’s health minister. The European Commission purchased 300 million more doses of BioNTech/Pfizer COVID-19 vaccines in early January 2021 and The European Medicines Agency expects AstraZeneca vaccine to be approved by January 29, 2021. Remarkably, the UK has moved ahead of the EU in the number of vaccines approved for use, currently at three, after authorizing the use of Moderna in early January 2021. While Serbia, a country at the crossroads of Central and Southeast Europe, has started inoculating Sputnik-V with top officials getting the jab to boost public trust in the vaccine; Serbia and Belarus are currently the only two countries in Europe using the Sputnik- V vaccine. Nevertheless, major concerns about the effectiveness and possible side-effects are circulating, since the trials are still ongoing and the data is limited, similar to the case of Sinovac. Despite all this, Sputnik-V post-registration clinical trials involved over 44,000 people in Russia, the UAE, India, Venezuela and Belarus.

At the time of writing this article, the global infections topped 95 million, according to Johns Hopkins University in Baltimore, with a death toll of 2,041,932. In other developments, the World Health Organization’s team of international experts from Australia, Britain, Germany, Japan, the Netherlands, Russia, Qatar and Vietnam, are in Wuhan investigating the origins of the COVID-19 pandemic. There’s light at the end of the tunnel with 319 treatments in total and 240 vaccines in development, according to Milken Institute, a nonprofit, nonpartisan think tank, COVID-19 Treatment and Vaccine Tracker; there’s hope for the normalization of everyday life. The three institutions, Novax, Johnson & Johnson, and Tongji Hospital; Wuhan, China, are all at the final stages, i.e., phase three of the trial, with others following not too far behind. *information was accurate at the time of writing this article 19/1/2021

Pinja is currently studying MSc Security and Crisis Management - Governance of Crisis at Leiden University. She joined IB Consultancy in November 2020.