WHO EUL on Sinopharm

Finally, the World Health Organization (WHO) issued emergency use listing (EUL) to Sinopharm of China for their vaccine against the coronavirus disease 2019 (COVID-19). The Chinese state-owned Sinopharm is among the first vaccine-makers that earlier successfully developed an anti-COVID vaccine late last year. But it was only on May 7 that the WHO granted this EUL while China had already distributed Sinopharm either by donation or sold to a number of COVID-impacted countries, mostly in the Middle East and Latin American countries.

In fact, the Sinopharm vaccine is being inoculated already to people in 40 countries that have approved emergency use authorization (EUA) in their respective Food and Drug Administration (FDA) authorities, according to the WHO monitoring. Per WHO record, Sinopharm got the fifth EUL among anti-COVID vaccine products that have already reached phase 3 clinical trials.

The WHO earlier granted EUL to four other vaccine products, namely: Oxford’s AstraZeneca; Pfizer BioNtech; Janssen of Johnson & Johnson; and most recently Moderna-MRNA1273, all from the United States.

From the WHO record also, there are a total of 111 anti-COVID vaccine candidates currently undergoing 326 clinical human trials in various stages, phases 1, 2, or 3 testing. Of these 111 anti-COVID vaccines, 14 of them have secured EUA by one or more countries.

It was our own FDA director-general Dr. Eric Domingo who first informed us about the WHO monitoring report on vaccine trials and EUA status during our previous week’s Kapihan sa Manila Bay zoom webinar. Domingo reported the same to President Duterte at the special meeting of the Inter-Agency Task Force on the Management of Emerging and Infectious Diseases (IATF-MEID) held Thursday night at Malacanang. The same “next slide, please” presentations to the President were made by the FDA chief again through virtual tele-conferencing when he joined at the IATF meeting held just last Monday night (May 10) in Davao City.

Of the 14 vaccines with approved EUA, Domingo noted, AstraZeneca is the Number One widely used in 93 countries, including the Philippines. This was followed by Pfizer being used in 85 countries; Sputnik-V from Russia’s Gameleya in 65 countries; Moderna in 46 countries; Janssen in 41 countries, and Sinopharm in 40 countries.

The rest of the 14 vaccines with EUAs include the Covishield by Serum Institute of India (SII) being used in 40 countries; Coronavac from Sinovac of China in 24 countries, including the Philippines; and, Bharat Biotech of India in 9 countries. And four other lesser known Chinese and Russian anti-COVID vaccines in limited use in their respective countries.

Domingo cited our FDA have so far approved the EUA of seven vaccine brands. Pfizer was the first one to secure EUA from us. Subsequently, our FDA approved the EUAs of AstraZeneca; Sputnik-V; Sinovac; Bharat Biotech; Janssen; and, Moderna got it just last week.

And soon, Domingo told President Duterte last Monday night, Sinopharm will get the eighth EUA from our FDA. Thus, the Philippines will join Hungary as the country with the most number of EUAs granted to eight vaccine brands.

The President on official photos showed him getting his Sinopharm jab from Department of Health (DOH) Secretary Dr. Francisco Duque III on May 3. Duque is the immediate head of Domingo since FDA is one of the attached agencies of the DOH.

Three days later, the Chief Executive  justified his taking the Sinopharm jab upon his doctors' advice. Citing it is his own life to decide, the 75-year-old President has publicly declared his preference to be inoculated with China-made vaccines.

But President Duterte ordered the return of 1,000 doses of Sinopharm that Beijing purportedly donated to the Philippine government. It was his response for the backlash in taking the Sinopharm jab even if our FDA has not issued it yet with the EUA.

For this, President Duterte made a public apology and admitted his mea culpa.

A day after the WHO granted EUL on Sinopharm,  Duque immediately ordered DOH to apply for EUA for it from his own FDA. So obviously, he won’t anymore have to return the donated Sinopharm vaccines.

It was actually the Presidential Security Group (PSG) that first got their Sinopharm jabs ahead of everyone else. During the televised emergency IATF meeting at Malacanang in December last year, the President revealed the PSG got Sinopharm jabs when he confronted Domingo on FDA probe into rumored smuggling into the country of China-made vaccines. PSG chief Brig. Gen. Jesus Durante III later confirmed at the Senate hearing they expect to receive at least 10,000 doses of Sinopharm vaccines of “donation” from China.

The PSG Hospital subsequently applied with the FDA for “compassionate special permit” (CSP) on the “donated” Sinopharm vaccines. Under this CSP, the PSG was required to submit report to the FDA of any serious adverse reactions or side effects to all who got the Sinopharm jabs for monitoring purposes.

It remains unclear though up to now if these 1,000 doses of Sinopharm vaccines were the same ones “donated” to the PSG.

Until last week he talked with us at the Kapihan sa Manila Bay webinar, Domingo has not received the PSG report on their Sinopharm use. In February this year, veteran newsman Ramon Tulfo who was once a Malacanang special envoy to China, claimed he, along with the PSG and other Duterte administration officials have allegedly gotten the Sinopharm jabs in October last  year. Tulfo also admitted he has applied to become official distributor of Sinopharm in the Philippines.

As of late, at least three local distributors have applied to import Sinopharm here, Domingo disclosed. But none of them submitted to FDA on the efficacy and safety data required for the grant of EUA to Sinopharm.

With the Sinopharm procurement now under DOH’s government-to-government arrangement, Domingo told the President, he  asked motu propio the WHO for copies of these data. Still, the WHO EUL on Sinopharm vaccine should not exculpate anyone who flouted the FDA law.