There is clearly a lot of money at stake in the race to end this disease – which to date has infected more than 29 million people and claimed the lives of almost 900,000 – and whoever develops the vaccine first, wins. This week Cuba begins clinical trials of Soberana 01.
Worldwide, a reported 200 research teams are currently working to develop a vaccine, with the World Health Organisation (WHO) monitoring some 140 of them.
Nonetheless, in specialised publications and news media in the United Kingdom and United States there are calls for caution and ‘not to lose hope’ concerning the most promoted vaccine contenders. It is common knowledge that behind the human and ethical interest in finding a drug to end the pandemic, pharmaceutical companies across the world are also racing against the clock to develop a vaccine.
Opinions on developing vaccines against Covid-19 therefore shift between optimism and caution, a hot topic in the news that is flooding media and social networks worldwide.
But vaccines do already exist. There is Russia’s Sputnik V, which the Russian Health Ministry has said will be rolled out as part of the third stage of clinical trials, or post-registration tests. The drug was developed by the N. F. Gamaleya Federal Research Centre for Epidemiology and Microbiology and has been registered ‘with conditions’.
Those most at risk, such as health workers and teachers, will be the first to be vaccinated, so as to avoid cases of infection among children. N.F. Gamaleya Centre director, Alexander Gintsburg, stated that the third stage of trials will be carried out on outpatient volunteers.
China also has a vaccine. The China National Intellectual Property Administration has stated that the Ad5-nCoV recombinant vaccine is the first in the country to receive a patent for use against Covid-19.
Ad5-nCoV is the result of a joint project between Chinese biopharmaceutical CanSino Biologics Inc. and a group of scientists from the People’s Liberation Army (PLA), led by epidemiologist Chen Wei.
The drug was approved for military use for one year, with the Central Military Commission responsible for authorising its use in any future plan for civilian vaccination. The post-administration data obtained from 508 volunteers indicated that the vaccine is safe, though adverse reactions included fever, arrythmia, diarrhoea and dizziness.
And then there is Cuba’s vaccine, Soberana 01, whose first stage of clinical trials began the week commencing 24 August.
According to the Cuban Public Registry of Clinical Trials, research to develop the prophylactic drug is being led by the Finlay Institute of Vaccines (IFV) and includes 676 people aged between 19 and 80 years.
According to this institution, phase one and two of the clinical trials should finish on 11 January, with the results available on 1 February – ready for publication on 15 February 2021.
IFV Director General and project leader, Vicente Vérez, has said that the study has already been authorised by the Centre for State Control of Drugs, Equipment and Medical Devices (CECMED).
He also explained that Soberana 01, approved by Cuba’s drug regulatory authority, is low risk, with few uncertainties and encouraging results in the preclinical phase, according to the Presidency of Cuba’s website.
Vérez explained that following the results of animal testing, Soberana 01 was first trialled on humans on 28 July, specifically on three of its researchers, who also presented with high immune response in the initial assessment.
Specialists from various institutions participated in the study, including the Centre for Molecular Immunology and the University of Havana.
The debate around the chances of the different trial vaccines clearly increased following Russia’s registration of Sputnik V – which has been called into question, particularly by Western laboratories and publications, due to a lack of evidence on its results in phase three.
But there is real fear and doubt. In fact, faced with the uncertainty of which vaccine will win the race, the most developed countries have started to buy hundreds of thousands of doses from different laboratories in an attempt to ensure supply.
The United Kingdom has signed agreements with potential providers like AstraZeneca, Pfizer/BioNTech and Valneva; while the United States already has contracts with Pfizer/BioNTech, Moderna, Johnson & Johnson, AstraZeneca and Novavax. (PL)