The Vietnamese Covid-19 vaccine is still waiting for approval while other countries are racing to find a cure. It’s time to fight back the Covid-19 disease.
Deputy Minister of Health, Tran Van Thuan – at the regular government press conference on September 6 – said that Nanogen Pharmaceutical Biotechnology Joint Stock Company needs to submit more research data of Nanocovax, Covid-19 vaccine. The data will be reviewed by the National Committee for Ethics in Biomedicine Research and the the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients before issuing a certificate for emergency use of the vaccine.
The required information includes safety for all subjects who have been vaccinated with at least 1 dose of Nanocovax vaccine so far, additional assessment of immunogenicity on new variants, the size of samples, as well as the 50% efficacy threshold set for COVID-19 vaccines by the World Health Organization. These requirements, according to the Deputy Minister, are salient because vaccines are a special product of concern for both communities and generations. Nanocovax is the protein subunit COVID-19 vaccine, which is in Phase 3a – midterm clinical trial and has not yet completed Phase 3.
How Covid-19 vaccines are authorized in other countries?
The first Emergency Use Authorization issued by US Food and Drugs Administration for the Pfizer-BioNTech Covid-19 vaccine for individuals 16 years of age and older on December 11, 2020. Later, WHO approved the emergency use of the vaccine, now known as Comirnaty on December 31, 2020.
The FDA’s reviewed and analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the Covid-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older. Based on results from the clinical trial, the vaccine was 91% effective in preventing Covid-19 disease, according to the FDA.
Dr Benjamin Coghlan, Senior Health Specialist at Asian Development Bank shared an example on Novavax, a prominent protein subunit vaccine against Covid-19. Novavax is seeking regulatory approval from WHO and several national and regional regulators throughout the world. Many of these regulatory bodies are conducting “rolling reviews” of Novavax such as immediately reviewing new clinical trial data as soon as it becomes available from the developer.
This is with a view to fast-track authorization of the vaccine rather than wait for the submission of all data after all phases of vaccine trials are completed. This has been a strategy employed by many manufacturers and regulators throughout the pandemic to speed up the traditional pathway to vaccine approval without skipping any of the well-defined steps to ensure vaccine safety and effectiveness.
In addition, some countries are making ‘advanced purchasing agreements’ (APA) before formal regulatory approval to ensure access to vaccines. This approach assumes that vaccines will ultimately be deemed safe and effective by the appropriate regulator. For instance, the European Commission approved an APA with Novavax on 4 August 2021 and pending approval of the vaccine by the European Medicines Agency (EPA).
While it is not the normal process for a regulator to authorize the use of a vaccine prior to the completion of Phase 3 clinical trials, some national regulators have approved vaccines for use even before Phase 3 trials were completed. Given the emergency nature of the pandemic and the difficulties with controlling spread without vaccines, Russia and China authorized the use of some vaccines in their countries.
According to Mr. Benjamin, vaccines for use in Vietnam are reviewed by Viet Nam’s National Regulatory Authority (NRA): “Viet Nam’s NRA has been assessed by the World Health Organization as a stable, effective and integrated regulatory system (Level 3 on a four-level scale). Nanogen does not need to submit clinical trial data for NanoCovax to the WHO for Emergency Use Listing (EUL) or any other regulator if they are only intending to use the vaccine domestically. They will, however, need to have approval from other countries and/or the WHO if they export the vaccine to other markets.”
There are several vaccines being used in many parts of the world that do not yet have WHO EUL. For example, Covaxin produced by India’s Bharat Biotech which is the vaccine being used in 9 countries. Sputnik V manufactured by Russia’s Gamaleya National Center has been approved in 79 countries. In total, 7 Covid-19 vaccines have received WHO EUL, whereas 22 vaccines have been approved by at least one country’s regulator, said Dr Benjamin.
Meanwhile, Korean pharmaceutical company HLB signed a memorandum of understanding (MOU) with Nanogen to acquire the rights to supply Nanocovax across the globe, except for in Vietnam and India on August 18. Nanogen also signed an agreement with an Indian company, Vekaria Healthcare, for technology transfer, production, and distribution of its Nanocovax Covid-19 vaccine earlier.
Beyond the vaccine
Vietnam will need 150 million vaccine doses to cover 70% of the population. By the beginning of September, the country had only obtained more than 20 million doses from many disparate sources. A number of vaccine transfer-and-produce initiatives have been endorsed by the Ministry of Health (Decision 2301/QD-BYT), to beef up vaccine production from Vietnam to around 200 million doses by the first half of 2022. In addition to that, the country has successfully secured technology transfer from Japan and Russia, according to Dr. Pham Cong Hiep RMIT Senior Lecturer and Research Cluster Lead. It is expected that the tech transfer of the Sputnik vaccine from Russia will be completed by the end of 2021
Joining the global vaccine supply chain will help Vietnam to achieve a number of its strategic goals. First, Vietnam can take advantage of its high-quality infrastructure in industry zones, and experienced workers in many high-tech firms to participate deeper in the value chain of vaccine production. Second, being able to master complex vaccine production know-how and establish capability to produce large-volume world-class vaccines can ensure Vietnam to reach its target of Covid-19 vaccine coverage of at least 70% of the population by Quarter 2/2022. Third, it can contribute to reducing global shortages and making vaccines more affordable to less developed countries like Vietnam, Dr Hiep explained.
Vietnam is also implementing the vaccine diplomacy strategy to obtain the fastest access to not only vaccines but also drugs and medical equipment. The Ministry of Health and overseas representative agencies have lobbied the governments of countries Japan, India, Switzerland… to successfully import millions of doses of drugs to fight Covid-19, according to the Deputy Minister.
In Vietnam, 6,408 patients are in serious condition on September 2. Vietnam ranks 161 out of 222 countries and territories, with an average of 4,951 infections for every 1 million people, according to the Ministry of Health. Therefore, the country will need to stay ahead of treatment therapy to avoid these numbers rising.
According to Professor Soren R. Kirchner – Professor at Andrews University in Vietnam: “It seems too late to just prevent against Covid-19 at this point. Vaccines are great for prevention, but now we also need to treat existing cases who are ill. I’ve been studying the patient numbers since July, and I think it’s time to put out the fire with therapeutics since it seems too late for containment.”
According to Prof. Soren, India’s therapeutics strategy can be suggested for Vietnam. India had an attack by Delta variant which lasted 120 days and killed hundreds of thousands. In India, used some therapeutics has flattened the death curve. Therefore, he proposed 3 strategies as therapies to the new development. Strategy 1 is to continue testing at home rather than in gathering situations. Early detection and treatment-is the hallmark of medicine in the west. Test and isolate to detect all F0.
Strategy 2 is Therapeutics! Therapeutics! Therapeutics! Distribution of medicine packages to include Covid-19 treatment pills and approved regimen should be sent to every household. However, he noted that therapeutics are not a substitute for vaccination. Strategy 3 is to encourage people who are not F0, F1, or even perhaps F3 to go back to work and enforce 5K Rules. Patients and at-risk persons such as the elderly and people with preexisting autoimmune conditions must be isolated and treated.
Vietnam needs to move with greater urgency on vaccines, which for prevention of cases and move faster on a new strategy to treat existing cases, while getting back to work. Prevention and therapy are two separate tools we must work with, according to Prof. Soren.