US health chief casts doubt on Russia's vaccine trials
Bella Perez-Rubio (Philstar.com) - August 12, 2020 - 6:27pm

MANILA, Philippines — The United States health chief on Wednesday emphasized the importance of providing transparent data in the effort to find a a safe and effective vaccine against COVID-19.

"This is not a race to be first," US Health and Human Services Secretary Alex Azar told reporters during a teleconference hosted by the US Asia Pacific Media Hub.

"The United States commitment...is that any vaccine will be proven to be safe and effective in ethical clinical trials, and the data will be made transparently available and reviewed by outside experts," he added.

Azar's remarks follow Russia's claim that it has produced the world's first vaccine offering "sustainable immunity" from the novel coronavirus which was met with skepticism from the international community.

President Rodrigo Duterte, however, has shown enthusiasm for Russia's vaccine, accepting the country's offer to participate in clinical trials and even going so far as to offer to be injected himself as a gesture of gratitude and trust.

Due to his advanced age and the fact that he is the president of the Republic of the Philippines, it is unlikely that he will actually be included in clinical trials.

In response to Duterte's remarks, Azar warned that Russia is only starting Phase 3 of clinical trials, which involves the large-scale testing of vaccines for efficacy and safety, while two of the US' six vaccines entered the same phase "weeks ago."

He added that "data from the initial trials in Russia have not been disclosed."

Despite this, the Washington Post reported that the Philippines may be included in the Phase 3 clinical trials of the Russian vaccine developed by Gamaleya Research Institute of Epidemiology and Microbiology.

As skepticism continues to grow amid these reports, the country's Food and Drug Administration on Wednesday assured that the Russian vaccine, dubbed Sputnik V, will be properly assessed as soon as it arrives.

“Once an application for clinical trial or registration of the Russian vaccine is filed at the [Food and Drug Administration], we will evaluate it accordingly, FDA Director General Eric Domingo told Philstar.com in a text message.

Domingo added that the FDA will only approve the use of vaccines if they have been used in widespread testing or Phase 3.

Why join human trials for a vaccine?

In June, Science and Technology Secretary Fortunato Dela Peña said that the country would likely be joining Chinese company Sinovac Biotech in conducting Phase 3 of their clinical trials for their COVID-19 vaccine.

He also explained the benefits of joining human trials, saying it would ensure both the country’s prioritization and FDA approval of the vaccine proves to be successful.

“For example, if we are not included in a clinical trial, such as the Oxford vaccine which is being reported to be very advanced, if this is introduced to the country, the FDA will still require us to undergo our own clinical trials. Because a new provision in our Universal Healthcare Act, which is probably a result of past lessons learnt from vaccines, added a Phase Four requirement,” he said in Filipino.

Phase 4 requires the country to conduct its own trial of vaccines even if it is approved by the FDA abroad.

Dela Peña said that the conducting of simultaneous trials here could circumvent a delay of six to nine months.

As of June, the COVID-19 task force has given the go signal for the Philippines’ participation in at least five clinical trials for vaccines against the disease.

Aside from Sinovac Biotech, the collaborating organizations include the Adimmune Corporation, the Academia Sinica, the Chinese Academy of Science - Guangzhou Institute of Biomedicine and Health and SinoPharm Group - Wuhan Institute of Biological Products and Beijing Institute. — with reports from Gaea Katreena Cabico

COVID-19 NOVEL CORONAVIRUS VACCINE
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