Vaccine: Getting close to the finish line

BABE’S EYE VIEW FROM WASHINGTON D.C. - Ambassador B. Romualdez (The Philippine Star) - October 18, 2020 - 12:00am

Presidential spokesman Harry Roque’s statement that “the pandemic is about to end” when some vaccine makers expressed interest to conduct clinical trials in the Philippines may sound overly optimistic to some, but there is no doubt that this COVID-19 scourge will come to an end since we are just a month or two away from seeing a safe vaccine ready for use.

Trials for several vaccine candidates being developed by pharma and biotech companies from many countries are now on phase three, with researchers working at a rapid pace getting closer to the finish line. The other good news is that several companies are also pursuing experimental treatments for patients with severe cases of COVID-19, with the US National Institutes of Health launching a study to identify as quickly as possible those that have shown promising results to determine whether they can move into larger-scale testing.

However, a few hiccups were reported in phase three trials of some vaccine developers such as Johnson & Johnson that had to pause the late-stage trial for its vaccine following an adverse reaction from one of the trial participants. Eli Lilly also had to stop the late stage trial for its antibody treatment due to safety concerns.

But according to medical experts, these delays during trials are “not uncommon” and do not necessarily mean that there is a problem with the vaccine or treatment. In fact, these pauses should reassure the public since they show that system checks put in place are actually working for everyone’s protection.

Among the companies pursuing experimental COVID-19 cures in the US, Regeneron is leading the way, with no less than Dr. Anthony Fauci saying that the Regeneron REGN-COV2 antibody cocktail may have actually helped President Trump – who had tested positive for COVID-19 – get “well” faster.

Here in the United States, the leading developers are Moderna and Pfizer, most likely the only two candidate vaccines that could possibly meet the Emergency Use Authorization guidelines of the US Food and Drug Administration by yearend. Pfizer is set to apply for emergency approval of its candidate vaccine this November, which is being tested on 38,000 participants worldwide, putting it at the forefront of the race. While vaccine testing (using different doses and techniques) normally takes years, Pfizer was able to do it quickly due to a new technique that can measure how well a volunteer’s immune system responds to a vaccine, the process becoming much faster with computer systems calculating the data.

“Never have we been in a scenario where you truly have seven billion people watching intently and following every single bit of progress under a microscope… and it’s good. It creates a more health literate community,” noted Dr. Isaac Bogoch, an infectious disease specialist and professor at the University of Toronto, over the intense scrutiny that the whole world is putting regarding the development of vaccines.

We’re glad the Philippines is taking part in the World Health Organization-led solidarity trials on potential vaccines because the bigger number of safe vaccines are made available, the faster the world can get back to “normal.” Regardless which country the developers are from, I am confident their vaccine candidates will most likely be safe because no country would produce a vaccine that could harm its own people.

Several pharmaceutical companies have already signed a confidentiality disclosure agreement (CDA) in preparation for phase three trials of candidate vaccines in the Philippines. Considering that we urgently need to get vaccines from wherever as soon as they are available, I was shocked to find out that DOH Secretary Duque has not signed a simple thing as a CDA with Pfizer.

DFA Secretary Teddy Boy Locsin mentioned our need for the vaccine as soon as it was available during a telephone conversation he had with US State Secretary Pompeo. I followed it up with a phone call to the White House NSA and everything went into motion, with Pfizer taking the lead in getting in touch with us.

Signing the CDA is not a commitment but simply gives the pharma company an assurance that their formula will not be disclosed. It’s only the first step to enable Pfizer to present what their candidate vaccine is all about, after which a panel of experts headed by DOST will then review the results of the Phase 1 and 2 trials in preparation for Phase 3 local trials. Once approval is given, the vaccine can then be sold in the Philippines.

I’m still dumbfounded why Sec. Duque has not signed the CDA. The other day, the State Department informed us the US government has ordered an excess of vaccines which they said will be made available to “close allies” like the Philippines. But what can I say? Countries like Japan, Thailand, Vietnam and so many others are already ahead of us.

Several big corporations such as ICTSI, SM, the Lucio Tan Group, San Miguel, the PLDT Group and other entities with a large number of employees have signified their intention to purchase the Pfizer vaccines for their workers and their families, significantly reducing the need for DOH to purchase the vaccines as they will just need our government’s approval.

We’re so glad the Senate has already approved the proposed bill granting anti-red tape powers to the President, not only because we need to be ready for foreign investors to come in once the pandemic is over but, more importantly, so we can cut the red tape in getting vaccines for at least 65 million Filipinos to effectively have herd immunity.

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Email: babeseyeview@gmail.com

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