TIMELINE: COVID-19 Vaccine Deal Sunk with Pfizer

MANILA, Philippines – As nations scrambled to get doses of the coronavirus vaccine from drug makers, the Philippine Health chief had been accused of “dropping the ball” by acquiring the vaccine deal with a drugmaker. based in the United States.

The serious accusations made by Senator Panfilo Lacson against Health Secretary Francisco Duque III have put the embattled official back in the hot seat, an unpleasant fact, considering that the latter has been haunted by many controversies since the start of the pandemic.

According to Lacson, Duque was “unable” to present the documents, such as a confidentiality agreement, necessary to finalize the COVID-19 vaccine deal with the US company Pfizer / BioNTech.

Lacson echoed the sentiments of Foreign Secretary Teodoro Locsin Jr. on Twitter Tuesday that the government was about to get 10 million doses of the COVID-19 vaccine from Pfizer until someone “dropped the ball”.

Duque denied Lacson’s statements and said that Pfizer did not set deadlines for the Confidentiality Disclosure Agreement (CDA).

“Pfizer did not set a deadline, nothing in all of our documents,” Duque said in a television interview on the ABS-CBN news channel.

“There is no such thing, that I did not act fast enough. The point is, you go through a process and when you go through a process you can’t rush things like that. You have to be careful, especially when it comes to a new and novel vaccine, “he added.

The Pfizer vaccine uses mRNA, a genetic molecule that carries the instructions for making proteins in our bodies.

He further said that the CDA with Pfizer was only filed on August 11.

“In fact, the CDA was intended to be signed, at the request of Pfizer, by the Office of the President,” he said.

“That would have prevented Pfizer from signing a CDA with many other government agencies. Therefore, it is a language that cannot be iterated, which is legal in the DOST (Department of Science and Technology) Office of the Executive Secretary, technical and legal offices of the DOH, we have to delete the provisions of non-disclosure. agreement, “he added.

(That would have prevented Pfizer from signing a CDA with many other government agencies. So it was supposed to be just one office, but it went through an iteration, the DOST legal, the Office of the Executive Secretary, and the technical and legal offices of the DOH, we have to delete the provisions of the confidentiality agreement.)

Here is the timeline for the CDA process between Pfizer, DOH and other government agencies according to Duque:

June 24
According to Duque, around this time, Pfizer submitted its overview of its vaccine candidate and development program.

June 29
“DOH, through the pharmaceutical division, referred the proposal to DOST-PCHRD (Philippine Council for Health Research and Development) as the lead agency in managing the development of vaccines for the response to COVID-19” he explained.

“[T]This is in conjunction with the resolution of the IATF (Interinstitutional Working Group) that designates DOST-PCHRD as the lead agency for the evaluation and, in parallel, the vaccine would have been evaluated by the ethics review (of) FDA (Philippine Food and Drugs Administration) ”, he continued.

6th August
Duque said they sent a letter to Pfizer, informing the company to contact DOST.

August 7th
He then said that Pfizer met with DOH officials on this day to discuss and talk more about the mRNA technology that is being used for the COVID-19 vaccine.

“That’s where I asked questions. Sabi ko, meron na ba experiments an ibang technology with an mRNA vaccine. They said yes, for HIV AIDS that’s it. There has been no experience. DOH also has no experience in its long years of immunization, we never had this type of technology, “he added.

August 11
A few days after the meeting, Pfizer sent the draft CDA that Duque said was to be signed by the Office of the Executive Secretary “on behalf of all government agencies.”

26 of August
“We support the legal service for the comments made by the corresponding technical offices,” said Duque.

He clarified that he cannot disclose a copy of the CDA to the public, otherwise he may be sued by Pfizer.

4th of September
“Pfizer met with officials from DOH, DOST, (Executive Secretary Salvador) Medialdea, to provide updates on their vaccine developments. So sinabi nila there are two vaccines rated in terms of safety and efficacy profile after phase one and phase 2 clinical trials. “

(Pfizer met with DOH officials, DOST, Executive Secretary Salvador Medialdea, to provide updates on their vaccine developments. They said there are two vaccines rated in terms of safety and efficacy profile after phase one clinical trials. and phase 2).

Duque previously explained that Pfizer does not want to conduct its Phase 3 clinical trials in the Philippines.

“We would have preferred to have clinical trial phase three in the Philippines just to be able to pass the ethnic divide because not all races will be responsive when it comes to potential side effects,” he said.

In addition, he stated that during that meeting, Pfizer spoke with them about the “potential supply of 100 million doses by the end of 2020 subject to regulatory approval.” Pfizer also mentioned a projection of 1.3 billion doses, which will be available by 2021.

However, the health chief clarified that the 10 million doses are not available only for the country.

“You can ask the vaccine czar about this, but (the) ten million will be for the global market, in addition to those given to source countries like the US, which I think will account for most of the supply of vaccines “.

September 17
DOH sent another letter to the Medialdea Executive Secretary’s office. In the letter, Duque said they detailed that on September 11 Pfizer received their comments on the CDA.

“You can iteration yan eh back and forth. We want this provision to not be one-sided. Pfizer will say that this is not what we want. It is not as simple as if I had just made a document to import the medicine that I used to use or the vaccine that I used before, ”said Duque.

(It goes through an iteration, back and forth, back and forth. We will tell you that we want this provision to not be one-sided. Pfizer will then tell us ‘no, this is what we want.’ This is not a simple document stating that want to import a medicine or vaccine that you have been using for years. This is new.)

24th September
After several reviews, Pfizer sent an email to DOH. I have been informed by the Office of the Executive Secretary that DOH will be the signatory to the CDA and requested a meeting, ”he said.

In a media forum Wednesday, Duque also brought this up, explaining that DOST was supposed to be the signatory to the CDA for COVID-19 vaccines.

September 25th
“We responded to the Philippine government side to first have an alignment meeting with Pfizer, as Pfizer initially requests that the executive secretary sign the CDA when DOH has previously been assigned to sign (on behalf of the national government,” Duque said.

“Eh hindi pala ako pwede to sign for the national government. I can only sign for DOH. So it is not surprising that DOST also signed a separate CDA with Pfizer in November, ”he added.

(Turns out, I can’t sign for the national government. I can only sign for DOH. That’s why it’s no wonder that DOST also signed a separate CDA with Pfizer in November.)

He also added that even the head of COVID-19 policy implementation and vaccine czar Carlito Gálvez, Jr. signed another CDA with Pfizer in November.

Duque signed the CDA on October 30, approximately three weeks after receiving notice from the Office of the Executive Secretary assigning DOH as a signatory to the Pfizer CDA.

“Even if there were some provisions that I think are a bit unilateral, but I still think that we need a vaccine to be able to sign it,” concluded the Secretary of Health.

(Even if there were some provisions that I think were a bit one-sided, I was thinking that we need the vaccine, so I signed it.)

What Happened Outside of Duque’s Timeline

October 7
On October 7, Senator Francis Tolentino asked DOST, DOH, and the FDA to act together and cooperate for the smooth conduct of clinical trials of a potential COVID-19 vaccine.

Tolentino raised the issue during the Senate hearing on the proposed DOST budget, DOST Secretary Fortunato Dela Peña said the Philippines has signed confidential data agreements on COVID-19 vaccines involving at least five countries.

However, Dela Peña denied having knowledge when asked about reports that COVID-19 vaccines are allegedly being distributed in the country, as well as whether these vaccines have gone through licensing procedures.

“This statement is as alarming as it is confusing. This begs the question: who is really in charge of clinical trials on COVID-19 treatments in the country? “

EDV

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