By: Yen Makabenta

First word
I WRITE this out of sheer ci-tizen concern and journalistic curiosity. I do not represent a business or political interest that Secretary Carlito Galvez said he was told to shun when President Rodrigo Duterte designated him as the country’s “vaccine czar” to undertake the procurement, purchase and distribution of a Covid-19 vaccine to meet our people’s needs.

At a press briefing last Thursday, the good secretary announced that the government would sign on Friday, November 27, an agreement with the private sector and British-Swedish pharmaceutical company AstraZeneca for the purchase of two million doses of its Covid-19 vaccine.

Secretary Galvez said the private sector would pay for the purchase of the vaccines, which it would be donating to the government.

As I was digesting this seemingly reassuring news, I was startled to find on my news monitor and the internet a new announcement from AstraZeneca about its vaccine.

AstraZeneca vaccine needs to undergo trial
On November 26, Bloomberg news and Newsmax TV circulated a report headlined: “AstraZeneca likely to run fresh global vaccine trial, CEO says.” The story read in full:

“AstraZeneca Plc is likely to conduct an additional global trial to assess the efficacy of its Covid-19 vaccine, according to the company’s chief executive officer, after current studies raised questions over its level of protection.

“The new trial would be run instead of adding an arm to an ongoing US trial and would evaluate a lower dosage that performed better than a full amount in Astra’s studies. The company acknowledged that the lower level was given in error fueled concerns.

“‘Now that we’ve found what looks like a better efficacy, we have to validate this, so we need to do an additional study,’ CEO Pascal Soriot said in his first interview since the data were released. It will probably be another ‘international study, but this one could be faster because we know the efficacy is high, so we need a smaller number of patients.’

“Astra shares extended declines, falling 0.8 percent in London.

“Soriot said he didn’t expect the additional trial to hold up regulatory approvals in the UK and European Union. Clearance from the US Food and Drug Administration may take longer because the regulator is unlikely to approve the vaccine on the basis of studies conducted elsewhere, especially given the questions over the results, he said. Authorization in some countries is still expected before the end of the year, he said.

“Astra and its CEO are facing scrutiny as the drugmaker responds to growing confusion over the vaccine. The company’s late-stage data initially increased confidence that the world would soon have multiple shots to combat the pathogen, following positive reports from front-runners Pfizer Inc. and Moderna Inc. But scant disclosures and the manufacturing discrepancy have sparked doubts among scientists and investors.

“Astra and its partner, the University of Oxford, reported Monday that a lower initial dose of the vaccine, followed by a full dose, produced a 90-percent efficacy rate, compared with 62 percent for two full doses.

“A day after the data were unveiled the head of the US vaccine program known as Operation Warp Speed said that the regimen showing the higher level of effectiveness was tested in a younger population. He also said that the half-dose was given to some people because of an error in the quantity of vaccine put into some vials. None of those details were disclosed in Astra or Oxford’s original statements.

“The company has previously said it was considering adding a new arm to its US trial to test the lower dosage.

“Astra and researchers have declined to provide more data ahead of a peer-reviewed analysis that is expected to be published in the coming weeks. Results have been submitted to an undisclosed journal, Astra said in a statement.

“Astra’s is one of three vaccines that could be approved before the end of the year. Pfizer and Moderna, which have both created vaccines using messenger RNA, published data earlier this month that showed their vaccines were about 95 percent effective, and Pfizer has applied to US regulators for emergency approval.

There’s added pressure on the Astra shot to succeed because it’s easier to store and the company is selling it at cost during the pandemic, which means many low- and middle-income countries are relying on it.”

PH buying AstraZeneca vaccine
“This coming Friday, we will sign the tripartite agreement where we will buy two million doses of the vaccine from the United Kingdom’s AstraZeneca. Joining us will be the private sector who donated these,” Secretary Galvez, the chief of the National Task Force Against Covid-19 said at Thursday’s press briefing.

Galvez said the United Kingdom and AstraZeneca wanted to make the vaccine accessible to all and were not seeking to profit from it.

The Philippines aims to vaccinate up to 75 percent of the population against Covid-19, but this would not be completed in one year, he said.

The government, he explained, could vaccinate only 25 million to 30 million people a year.

One of the reasons for the slow pace was vaccine supply and demand in the world market, he said.

The vaccine is expected to become available either in May, June or July next year, so the immunization drive is likely to start late in the second quarter of 2021, he said.

He also cited the logistics involved in the endeavor.

The country’s previous immunization drives targeted only about 5 million people a year, he noted.

The government would have to take into consideration cold chain storage and management of the vaccines, he said.

If it would use a vaccine needing cold chain storage, there are limitations to this, he added.

He also said officials were assessing and conducting an inventory of the supply chain facilities of the Department of Health and the private sector for the vaccines.

He said that once the contract for the vaccine has been signed, the government would plan the delivery schedule, storage and distribution with the vaccine manufacturer.

The government will also tap the services of the private sector to help it come up with a systematic plan using information technology and GPS technology, he said.

Galvez also assured the public that the Covid-19 immunization drive would be free of political color, even if it would likely take place in the run-up to the 2022 elections.

The President’s goal is to contain the virus and end the outbreak in the country, as he has seen the suffering of the Filipino people, Galvez said.

He said the President wanted to ensure this by appointing him to the task of overseeing the matter, as he was not involved in politics.

Galvez was a military general before he joined the administration as peace process adviser after his retirement.

Problem with AstraZeneca deal
There is a horrendous problem with this tripartite deal. The AstraZeneca vaccine for Covid-19 does not exist yet. It is medical relief that is still in the making. It will probably pass muster after its coming global trial. But in the meantime, it is not yet a vaccine against the coronavirus.

Meanwhile, the US government is set to start deliveries of the Moderna and Pfizer vaccines as early as next week.

President Trump made the announcement during a special Thanksgiving holiday message to US troops overseas via teleconference. He said front-line workers, medical personnel and senior citizens would be the vaccine’s first recipients.

Eventually, the Covid vaccine frontline will be joined by AstraZeneca and other vaccines under current development, including the Russian and Chinese vaccines which we once thought would be first in the line.

If the signing of the tripartite agreement pushed through on Friday, Secretary Galvez has much explaining to do about the deal.

Source: Manila Times 28-11-2020