imyeyes-banner-sqIn My EyesBy Edward B. Antonio

Anti-COVID vaccine, who wants to be first?

The race is on for the anti-COVID 19 vaccine, fellas.

Is somebody already near there the finish line?

This early (or late), Russia and China are the preferred vaccine suppliers once the vaccine is perfected.

President Rodrigo Duterte said he preferred COVID-19 vaccine supplies to come from either China or Russia who both have submitted applications to conduct clinical trials for their inoculations in the Philippines.

“For me, either China or Russia, I am ok,” Duterte said.

 Just this November, Clover Biopharmaceuticals is seeking to conduct late-stage clinical trials in the Philippines of its coronavirus vaccine. Clover is the second Chinese developer to apply for Phase 3 clinical trials in the Philippines following Sinovac Biotech, which is seeking to begin trials of its vaccine by December. Aside from Clover, the Philippines is also evaluating COVID-19 vaccines of Johnson & Johnson’s Janssen and Russia’s Gamaleya Research Institute for late-stage trials.

Just recently, Russian President Vladimir Putin announced that Russia has become the first country in the world to approve a COVID-19 vaccine after less than two months of human testing, calling it Sputnik V, in reference to Russia’s triumph in 1957 being the first country in the world to launch a space satellite.

Shortly after Putin’s announcement, President Rodrigo Duterte said he had accepted Putin’s offer to provide the country with a vaccine against COVID-19, and that he is willing to try it for himself during clinical trials. Moscow hopes to supply the Philippines with the Russian COVID-19 vaccine by the year’s end if joint clinical trials prove successful, Russia’s ambassador to Manila, Igor Khovaev said.

   Russia’s Sputnik V has been registered by the Russian Ministry of Health in August and approved for distribution in Russia despite international criticism that it had only been tested in a small number of people during Phase 1-2 trials. The Phase 3 trial has yet to be conducted.

“If the results of (the) joint clinical trials Phase 3 are positive, the supply of Russian vaccine (in the Philippines) can start by the end of this year,” Khovaev said, with the hope that Russia’s ongoing bilateral talk to produce the vaccine locally will push through.

But once the vaccine is ready for marketing, who will be the first to be injected?

“Certainly not me,” exclaimed a government employee, citing the deaths caused by the infamous dengvaxia vaccine designed to contain the deadly dengue virus.

“The ghost of dengvaxia is still haunting. There’s already a phobia or fear for new vaccines,” said another employee.

Why does it take a long time before an anti-COVID vaccine is discovered? Why is it so hard to develop a vaccine?

A key challenge in developing vaccines for emerging infectious diseases is that each pathogen uses a different mechanism to infect cells and elicits a different immune response from the body. The majority of vaccines are built from the ground up to address these unique factors and need to undergo rigorous efficacy and safety testing—a process that can typically take up to six years. The majority of vaccines currently being tested and developed rely on previous research addressing other types of infectious diseases.

What are these so-called clinical trials, fellas.

My research says that clinical trials are scientific studies designed to test the safety and usefulness of new medical interventions such as treatments, devices, preventative care, screening or diagnostic procedures, and more.

There are four phases of clinical trials that each inform decisions made in the next phase:

Phase I: Establishing the safety and correct dosage of a treatment

Phase II: Investigating the efficacy and side effects of a treatment in patients with the disease

Phase III: Further investigation into efficacy and monitoring of adverse side effects

Phase IV: Assess the cost-effectiveness and performance of a treatment in real-life scenarios after the treatment has been approved by the Food and Drug Administration

In the interest of time for COVID-19, instead of searching for a new treatment, scientists have opted to test treatments that have already been approved for other diseases or have been tested in humans. By starting with a treatment that has been tested extensively in humans, researchers can take advantage of the years of research, preclinical trials and early phase safety trials that have already been conducted on these drugs to move quickly into human patients.

Further, the FDA cited possible side effects of COVID-19 vaccine in ongoing trials.

In the middle of ongoing COVID-19 immunization trials, the Food and Drugs Administration reminded the public of the possible side effects of these vaccines being developed.

Interviewed by the media, FDA’s Dr. Eric Domingo noted that side effects depend on the type of the vaccine that is being tested.

“Unang-una ‘yung mga local side effects: pamamaga sa site ng injection, ‘yung pananakit ng katawan. Merong iba nagkakaroon sila ng mild symptoms: pamimigat ng katawan right after the vaccine,” he said.

He also said that a vaccine could also lead to a disease as one of the possible side effects.

“Ang isang bakuna maari rin siya maging cause ng sakit. So kailangan tingnan mo rin kung magko-cause siya noong parang sakit ng COVID-19 o iba pang sakit o kung wala siyang effect,” he added.

He assured, however, that the FDA will look into these possibilities before certifying any vaccines against COVID-19.

Health Undersecretary Maria Rosario Vergeire said that the government will still subject the Russia-made vaccine to regulatory procedures before clearing it for clinical trials.

“Just like any product, any other new technology katulad ng bakuna, idadaan natin ‘yan sa regulatory procedures,” she said.

Again, the lingering question looms: Who wants it first aside from President Duterte?

Who gets coronavirus vaccine first? Philippines needs ‘foresight’, says governor

“The Philippine government should have “foresight” on how the vaccine will be administered to the 110 million Filipinos once it becomes available. Authorities “should be ready to respond” to questions on how it will administer 220 million shots of the vaccine, with each person requiring 2 shots of the drug,” said Cavite Governor Jonvic Remulla.

He said we should have the foresight and prepare for the arrival of the vaccine

“How do we do it without creating the least amount of panic and hysteria? Who gets it first and how do people get it quickly enough?” he said on Facebook.

And who should be vaccinated?

Duterte declared that he wanted to immunize every one of the country’s 113 million people but priority would be given to the poor, the police and military personnel.

“All should have the vaccine without exception,” he said in one of his televised addresses.

And when will be the vaccine available?

Department of Science and Technology Secretary Fortunato dela Pena said that it would still take time to conduct clinical trials and to manufacture the vaccine from other countries.

“We still are looking at the end of trials in the second quarter of 2021. And between the end of trials, to the approval by FDA for application, for use, and the actual vaccination, mass vaccination, it will still take some time. Our original estimate of mid-2021 is still the most optimistic. Mid-2021 is optimistic. I suspect we’ll have to live with our current normal for the full of 2021,” he said.

And the funding?

“I have the money already for the vaccine. But hahanap pa ako ng maraming pera (I will look for more money) because, you know, there are now 113 million Filipinos and to me, ideally, all should have the vaccine. Without exception, lahat (all),” said Duterte.

Finance Secretary Carlos Dominguez III targets a P20-billion fund for the purchase of a COVID-19 vaccine. This fund will come from a loan to be provided by the Land Bank and the Development Bank of the Philippines, two government financial institutions. The loan will be given to the Philippine International Trading Corp, which has been authorized to purchase vaccines for the government.

This fund is to shoulder only an “initial” batch of vaccines.

Apart from this, there’s a P2.5-billion allocation for vaccines in the proposed 2021 national budget.

And so, let’s go back to our initial question.

Who wants it first? All.

Who should be vaccinated? All.

 What can you say, fellas?