How the Philippines can prepare for the COVID-19 vaccine

It is not simply waiting for a vaccine to be developed against the virus that the world is currently fighting, it is about having the appropriate protocols, laws and systems to receive it. BY MELVIN SANICAS, MD

ANCX | May 10, 2020

At least 102 organizations worldwide are working to develop and test vaccines against SARS-CoV-2, the coronavirus that causes COVID-19. The first candidate for the COVID-19 vaccine entered human clinical testing on March 16, 2020, just 2 months after the release of the virus’s genetic sequence. This has never happened before.

Several companies are operating at “warp speed” to develop vaccine candidates and conduct clinical trials, including pharmaceutical giants like Johnson & Johnson, GlaxoSmithKline, Sanofi, AstraZeneca and Pfizer, working together or creating their own. Vaccines generally require 10 to 15 years of research and testing. The mumps vaccine was the fastest in history from the laboratory (1963) to the license (1967). Assuming that the “12 to 18 month” schedule often cited for the COVID-19 vaccine actually occurs, the earliest we can hope for is mid-2021. For now, we should start preparing for its arrival and try to find effective therapies until the vaccine is ready.

In the past, only six percent of vaccine candidates ended up on the market, so we expect at least six to hit the finish line. With the world population in 7.8 billion As of May 2020, if we were to vaccinate everyone, these six organizations must produce at least 1.3 billion doses each. This also assumes that the vaccine requires only one dose, and the world population has not changed significantly since then. Once a vaccine is licensed, there will still be several challenges in addition to supplying the vaccine.

Regulatory review and approval

Countries must prepare their regulatory processes. This includes (1) clinical evaluation, (2) chemistry, manufacturing and control (CMC) and quality, and (3) mechanisms to accelerate the process of receiving regulatory documents from other countries specifically those that manufacture vaccines. National regulatory authorities (NRAs), such as our Philippine Food and Drug Authority, should exchange information on COVID-19 policy issues and align with other regulatory agencies both in the region (through the Pharmaceutical Products Task Force of the ASEAN) as with the largest and most advanced group. ANR to improve efficiency in regulatory decision making.

System and prioritization

In most countries, vaccination focuses almost exclusively on young children. While some children and babies have been sick with COVID-19, adults account for the majority of known cases to date. How do we ensure that we can reach high-risk groups? 1) Older adults, immunocompromised patients, and those with chronic lung and health conditions and diabetes at increased risk of serious illness. 2) Health workers and essential non-health workers can be justifiably prioritized due to their contribution to the health and well-being of the community. Your health helps preserve the health of others.

WHO’s resource allocation and priority setting guidelines recommend prioritization of those who fall into the categories presented in the table below.

The country should begin to formulate strategies on how the vaccine should be implemented, starting with the most susceptible groups and then towards members of the immediate family of vulnerable groups and gradually moving on to the rest of the population until community immunity is achieved and virus transmission stops. . Centralizing the availability of vaccines, once available, can extend its benefits to more people and avoid a situation where only the people who can afford the highest prices get vaccinated first.

Legal agreements

In 2009, with the H1N1 flu pandemic, some industrialized countries were well prepared with advanced purchase contracts for vaccine supplies that could be activated as soon as a pandemic was declared. Those without these contracts did not have access to the vaccine until manufacturers shared part of their production with the World Health Organization (WHO). Countries can reach agreements with one of the main companies or with several companies trying to make a vaccine, but nobody knows which of the 102 organizations will finally have a safe and effective vaccine. On a positive note, WHO will coordinate this for COVID-19, but establishing legal agreements between vaccine manufacturers and recipient countries can be time consuming.

The time taken to develop and test COVID-19 vaccines, hopefully 12 to 18 months, but more realistically, gives us the opportunity to address these challenges so that once a vaccine is finally available, it can be deployed effectively and efficiently.

Mass production is extremely important in a pandemic, when billions of doses are needed. There are more than 40 manufacturers of seasonal influenza-capable vaccines, but together they can only make more than six billion doses. Some resource countries are now trying to increase their local vaccine production facilities. Even in the developing world, there are now more than 50 vaccine manufacturers in 17 countries and territories, producing and supplying more than 40 different types of vaccines. Local vaccine production provides significant benefits to the country not only during a pandemic, but also in the manufacturing capacity of other vaccines (such as pediatric vaccines or seasonal influenza). This should be included in all countries as a matter of national security.

Many developing countries like Vietnam, Indonesia, Bangladesh, Thailand and Pakistan have local vaccine manufacturing capacity. The Philippines has some of the best scientists in this part of the world, and we have institutions like the Research Institute for Tropical Medicine and the National Institutes of Health at the University of the Philippines that already do top-notch research. Perhaps after the pandemic, it is time to review the idea of ​​having local vaccine manufacturing capacity in our country.

Dr. Melvin Sanicas (@Vaccinologist) is a public health doctor specializing in vaccines and infectious diseases. Dr. Merlin Sanicas is a scientific doctor specializing in molecular biology and immunology of cancer.