An infectious disease expert working for the government estimates that the earliest time the Philippines would approve a COVID-19 vaccine for distribution is in the second quarter of 2021 or the months of April to June.
Dr Jaime Montoya, executive director of the Philippine Council for Health Research Development, said this projection takes into consideration the time it will take to conclude crucial Phase 3 trials and the approval process of food and drug administrations.
“My estimate is that it will be available in the Philippines, second quarter of next year,” he said in a Rappler Talk interview on Friday, September 18.
Dr Melvin Sanicas, a Filipino vaccine expert based in Switzerland, said Montoya’s estimate is “reasonable” but that it’s a “best-case scenario.”
Montoya’s estimated timeline is broken down as follows:
- November or December 2020 – Earliest conclusion of Phase 3 trials of any of the 9 most advanced vaccine candidates
- January to March 2021 – Food and Drug Administrations (FDA) of the countries where the vaccine candidates are developed approve the vaccine for distribution, based on their assessment of Phase 3 trials.
- April to June 2021 – The Philippines’ FDA approves a vaccine for local distribution.
This timeline is hinged on many things going right.
The assumption is that Phase 3 trials will run smoothly, which is not always the case. Trials for the vaccine being developed by Oxford University and AstraZeneca, for example, were paused when one of the volunteers experienced an illness. Because the illness turned out to be unrelated to the vaccine, the trials were resumed. But hiccups like this, or even bigger obstacles, can still threaten the progress of Phase 3 trials of all vaccines in the works.
Phase 3 trials are a crucial stage that involves testing thousands of people and comparing results with volunteers given a placebo. This determines if the vaccine is effective in protecting against SARS-CoV-2, and can reveal evidence of other possible side effects that may have been unseen in earlier studies.
If a vaccine’s Phase 3 trials go well, the results would still have to be assessed by FDAs of its home country and countries that want to distribute the vaccine domestically, like the Philippines.
Montoya said that it’s possible for Phase 3 trial data to be submitted to both FDAs simultaneously but this process could lengthen the time it will take for the Philippine FDA to approve the vaccine for distribution. If the home country’s FDA were to approve it first, which Montoya estimates could take a month, the Philippines’ FDA’s assessment would be aided by the approval of the home country’s FDA.
Managing expectations set by Duterte
The more realistic expectation of a vaccine approval in the Philippines by the middle of 2021 is in stark contrast to the remarks of President Rodrigo Duterte that Filipinos need only wait until December for a vaccine.
“I promise you, by the grace of God, I hope by December we would be back to normal…. Hintayin lang ho ninyo by December kung makatiis kayo (Just wait for December, if you can stand it),” he said on July 31.
A month later, Duterte claimed that certain vaccines are to be “distributed worldwide by September, October” of 2020, again setting expectations.
“When the President said that the vacines are available, he’s actually correct. It will be available maybe in their home countries but it’s unlikely to be available in other countries like the Philippines because, as I said, it will also take time for them to submit their applications to our FDA and for FDA to review it before it can issue an approval for the said vaccine,” said Montoya.
Consistent with his geopolitical stance, he’s given more praise to China and Russia for their assurances that the Philippines would get some level of “priority” access to their vaccines.
But he has slammed “Western” companies, likely referring to the US and European companies, for supposedly demanding a “reservation fee” which Duterte refuses to pay.
Montoya said this fee likely refers to Advance Market Commitment (AMC), which pharmaceutical companies usually ask from governments or other buyers, not just as advance payment but to boost its funding for vaccine development.
Ironically, the Philippines has already agreed to contribute to the AMC being collated by the Gavi COVID-19 Vaccines Global Access (COVAX) Facility. The Duterte administration is ready to cough up P1.5 billion for the program which ensures that the Philippines and other participating countries will get 20% of their needed vaccine supply from a manufacturer.
Upcoming hurdles: Securing supply and distribution
But even with Philippine FDA approval of a vaccine, there’s still the challenge of securing a supply of the vaccine, and then distributing it efficiently to Filipinos.
Montoya said that through the COVAX Facility, the Philippines is assured at least of 20% of its vaccine needs, which could mean two doses of a vaccine for around 10 million people. This is if the Philippines’ vaccine needs amount to immunization of 60% of its population, the Department of Health threshold for herd immunity.
But the private sector could move independently of the government and secure its own supply of an FDA-approved vaccine. This means that Filipinos who can afford to can buy a vaccine from their doctor even ahead of the free immunization by the government, which would likely cover only health workers and the poorest Filipinos anyway.
Let’s say a vaccine does reach a good number of Filipinos. That doesn’t mean health measures like mask-wearing and social distancing will be lifted.
The government will have to see the effects of the vaccine and a significant decrease in the number of infected.
“The effect is not immediate. Yes, you have a vaccine. Yes, you may be protected but of course we still have to see first of all, whether you will have the antibodies and whether the antibodies will be sufficiently high enough and if it will last for a long time,” said Montoya.
Some scientific groups say that a vaccine may have to be administered every year or once every two to 3 years.
Authorities would have to prepare for logistical concerns like ensuring a “cold chain” for a vaccine, or ways of transporting a vaccine such that it is kept to a certain low temperature. – Rappler.com