DOH, Roque clarify: EUA needed before using big batch of Covid-19 vaccines
THE Department of Health (DOH) on Tuesday clarified that before it accepts donated vaccines, it should first secure an emergency use authority (EUA) from the Food and Drug Administration (FDA) to be able to administer the medicine.
“We will wait for the issuance of an EUA by the Philippine FDA before we accept and administer the donated vaccines,” the DOH said.
It’s the same thing with vaccines that the government plans to procure, the DOH added.
The DOH issued the clarification after FDA Director General Enrique Domingo was quoted as saying that even if the EUA has not been granted yet, the DOH can still accept the donation.
“Pero desisyon nila [DOH] yun kung tatanggapin nila at gagamitin nila [The decision lies with the DOH if they will use or accept it],” Domingo said, referring to China’s reported to donate 500,000 doses of Covid-19 vaccines to the Philippines.
The donation was announced by China’s State Councilor and Foreign Minister Wang Yi during a bilateral meeting with Foreign Affairs Secretary Teodoro L. Locsin Jr.
Bayanihan Act
The DOH will be able to use donated vaccines, which are not registered with the FDA, as such is allowed under the Bayanihan Act, Domingo said in an online interview with PTV.
“That is why DOH is very careful in accepting such unregistered product, which they accept as donation, since they take responsibility for it,” Domingo said.
Presidential spokesperson Harry Roque noted the said policy for using unregistered vaccine through a “special authorization” might not apply with the latest batch of Covid-19 vaccines to be donated by China.
He pointed out that special authorization is only allowed for small batches of vaccines.
“500,000 doses is not a small batch. It is intended for 250,000 people so that definitely requires an EUA (emergency use authorization) or general use authorization (GUA),” Roque said.
Both EUA and GUA are issued by FDA for drugs or vaccines before the said products could be used locally.
To recall, the Presidential Security Group (PSG) earlier used unregistered Covid-19 vaccine, which was reported;y donated by the Chinese government
Roque said currently, the Chinese government has yet to disclose the brand of the 500,000 doses of Covid-19 vaccines it will donate, and when it will be shipped to the country.
He also said they are still waiting for confirmation on whether the said donated doses will be applied to the 25-million-dose order of the government with Chinese drug maker, Sinovac, or to future orders.
Meanwhile, the Covid -19 cases in the country surged to 504, 084 on Tuesday.
Lacson: No ‘agenda’
Also on Tuesday, Senator Panfilo Lacson debunked insinuations on Senators agenda in pursuing the vaccine inquiry, voicing hopes vaccine officials learned “hard lessons on transparency.’
“While there is still a long way to go as far as the government’s vaccination efforts are concerned, the controversy involving Covid-19 vaccines from Sinovac should be a hard lesson on honesty and transparency for officials in the program, Lacson said.
Had the officials been forthright about the conditions of negotiations with Sinovac early on, there would have been no speculations or suspicions about the matter,
he said in an interview on ANC, stressing that while Congress – the Senate and House of Representatives – are willing partners of the executive department, lawmakers “need to be informed also what happened to the appropriations we gave you.”
In his privilege speech on Monday, Lacson noted that when the Senate hearings raised more questions than answers about Sinovac, “our officials were both tongue-tied and stuttering, leaving us with a string of flip-flopping pronouncements.”
Lacson debunked insinuations that some senators had personal or political motivations in the hearings. “I haven’t heard of any senator who has expressed preference for the Pfizer vaccine or any brand for that matter,” he said, adding that “what we are doing in the Senate is an exercise of our oversight function over the appropriations laws that we passed, particularly on the purchase of the vaccines.”
He stressed, “There is no personal or political agenda involved in our inquiry as insinuated by Secretary Carlito Galvez Jr. earlier. Most of us who participated in the public hearings of the Committee of the Whole merely want to get straightforward and honest responses from the concerned authorities so we will be informed for our future reference in our legislative work. Instead,
the resource persons were groping, inconsistent, flip flopping and even evasive in their responses – hence our misgivings and apprehensiveness,” he added.
He recalled that when the Senate conducted inquiries on the anomalies in the Bureau of Customs, Bureau of Corrections and Philippine Health Insurance Corp. (PhilHealth)/Department of Health, “enough information was gathered that led to the filing of criminal and administrative cases by the Department of Justice and the Presidential Anti-Corruption Commission, and
could have possibly tightened the noose on those responsible for the pillage of public funds or prevented them to further bleed dry the public coffers.”
He added, “Isn’t that how the executive and legislative departments work as a team in fighting corruption?”
The suspicion of senators – and netizens – was aroused when officials would not disclose pricing and other conditions of the negotiations with Sinovac, a privately owned Chinese firm. The officials also were not forthright in their answers during Senate hearings last week, he said.
He added it was only recently that Galvez declared an “indicative price” of P700 for the Sinovac vaccines. “If at the outset during our first hearing last Jan. 11, he already declared we can get Sinovac vaccines for P700 thereabouts, then that’s the end of the story,” he said.
Nondisclosure agreement
For his part, Justice Secretary Menardo Guevarrra said there is nothing wrong with the nondisclosure agreement on the prices of the vaccine being obtained by the government.
However, Guevarra stressed that the efficacy and safety of these vaccines should be publicly disclosed as the lives of people who will be inoculated are on the line.
“There may be some good reason for nondisclosure of the commercial terms such as price competition, distribution channels, etc. I believe, however, that absolute transparency is necessary in relation to the safely and efficacy of the vaccine, as the very lives of our people are at stake,” Guevarra pointed out.
He made the statement in reaction to criticism on the refusal of government officials to disclose the vaccine costs, citing nondisclosure agreements with manufacturers.
The DOJ chief’s statement also followed several reported deaths of elderly people inoculated with Pfizer-BioNtech Covid-19 vaccine in Norway.
Guevarra said the negotiated procurement of vaccines under the Procurement Law is allowed, especially in times of emergency such as the pandemic,.
“Our Procurement Law expressly authorizes negotiated procurement by government in emergency cases such as when there is imminent danger to life during a state of calamity,” he explained.
The Philippine government, through vaccine czar Galvez Jr., has been negotiating with vaccine manufacturers for the country to get a share of their vaccine production.
But Galvez declined to disclose how much it would cost the government to obtain the Sinovac vaccine as this might affect ongoing negotiations to secure vaccines from other manufacturers.
“I have not seen the tripartite agreement among the national government, the local government sector, and the vaccine manufacturer, so I am not in a position to comment on whether the non-disclosure provision is anchored on a sound policy basis.”
“What I know, however, is that the tripartite agreement is a broad preparatory agreement, to be followed by actual supply contracts containing specific terms, such as on pricing,” he noted.