How the Philippines can prepare for the COVID-19 Vaccine 2
If the 12 to 18 month minimum period were to be followed, we should expect a vaccine by mid-2021. But are we ready for it? REUTERS/Dado Ruvic/Illustration
Culture

How the Philippines can prepare for the COVID-19 Vaccine

It isn’t merely a matter of waiting for a vaccine to be developed against the virus the world is currently battling, it is about having the proper protocols, laws, and systems in place to receive it. BY MELVIN SANICAS, MD
ANCX | May 10 2020

At least 102 organizations around the world are working to develop and test vaccines for SARS-CoV-2, the coronavirus causing COVID-19. The first COVID-19 vaccine candidate entered human clinical testing on March 16, 2020, just 2 months after the genetic sequence of the virus was released. This has never happened before.

Several companies are operating at “warp speed” to develop vaccine candidates and run clinical trials, including pharma giants like Johnson & Johnson, GlaxoSmithKline, Sanofi, AstraZeneca and Pfizer, either working together or creating their own. Vaccines typically take 10 to 15 years of research and testing. The mumps vaccine was the fastest one in history from lab (1963) to licensing (1967). Assuming the often quoted “12 to 18 months” timeline for the COVID-19 vaccine actually happens, the earliest we can expect it 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 end up in the market so we expect at least six to reach the finish line. With the world population at 7.8 billion as of May 2020, if we were to vaccinate everyone, these six organizations need to 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 besides vaccine supply.

 

Regulatory review and approval

Countries should prepare its regulatory processes. This includes (1) clinical evaluation, (2) chemistry, manufacturing, and control (CMC) & quality and (3) mechanisms to fast-track the process of receiving regulatory documents from other countries specifically the ones manufacturing the vaccines. National regulatory authorities (NRA), such as our Philippines Food and Drug Authority, should  exchange information on COVID-19 policy issues and align with other regulatory agencies both in the region (through the ASEAN Pharmaceutical Product Working Group) and the bigger and more advanced NRAs to enhance the efficiency in regulatory decision-making.

 

System and prioritization

In most countries vaccination focuses almost entirely on young children. While some children and infants have been sick with COVID-19, adults make up most of the known cases to date. How do we make sure we can reach the high-risk groups? 1) The older adults, immunocompromised patients, and those who have chronic health and lung conditions, and diabetes who are at higher risk for serious illness. 2) The healthcare workers and essential non-healthcare workers can justifiably be prioritized because of their contribution to the health and well-being of the community. Their health helps preserve the health of others.

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

Priority population

Rationale for prioritization

Those at greatest risk of becoming infected and seriously ill

Maximize benefit of vaccine

Those who, if vaccinated, would prevent the greatest spread of the virus

Maximize benefit of vaccine

Those who have volunteered to participate in research aimed at developing the vaccine

Reciprocal obligation to those who were voluntarily put at risk to aid in this effort

The country should start formulating strategies on how the vaccine should be deployed starting with the most susceptible groups and then into the immediate family members of the vulnerable groups and gradually transition into the rest of the population until community immunity is achieved and transmission of the virus stops. Centralizing the availability of vaccines, once available, may extend their benefits to more people and prevent a situation where only the people who are able to pay the highest prices are 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 had no access to the vaccine until manufacturers shared some of their production to the World Health Organization (WHO). Countries can make agreements with one of the major companies or with multiple companies trying to make a vaccine, but which of the 102 organizations will finally have a safe and effective vaccine is anybody’s guess. On a positive note, WHO will be coordinating this for COVID-19, but establishing legal agreements between the vaccine manufacturers and recipient countries can be time consuming.

The time needed to develop and test COVID-19 vaccines—optimistically 12 to 18 months but realistically longer—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 over 40 vaccine manufacturers with seasonal influenza capacity but together they can only manufacture over six billion doses. Some countries with resources are now trying to increase their local vaccine production facilities. Even in the developing world, there are now over 50 vaccine manufacturers in 17 countries and territories, producing and supplying over 40 different types of vaccines. Local vaccine production provides significant benefits for the country not only during a pandemic but also in manufacturing capacity of other vaccines (like pediatric vaccines or seasonal flu).  This should be included in every country as a matter of national safety.

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 University of the Philippines-National Institutes of Health already doing world-class research. Perhaps after the pandemic, it is time to revisit the idea of having local vaccine manufacturing capacity in our country.

 

Dr. Melvin Sanicas (@Vaccinologist) is a public health physician specializing in vaccines and infectious diseases. Dr. Merlin Sanicas is a physician-scientist specializing in molecular biology and cancer immunology.