Selasa, 22 Desember 2020

From shortlisting promising candidates to negotiations: How Singapore procured its first COVID-19 vaccine shipment - CNA

SINGAPORE: When Singapore’s first shipment of COVID-19 vaccines from Pfizer-BioNTech touched down at Changi Airport on Monday (Dec 21), the relief on the tarmac was palpable.

Just hours before, fears of supply chain disruptions had emerged.

European countries had shut their borders to isolate Britain after reports of a more infectious COVID-19 variant there accounted for a fresh wave of cases.

Fortunately, Singapore was prepared for such situations, the Economic Development Board (EDB) told CNA.

"To mitigate the risk of supply disruptions resulting from new waves of infection in other countries, we worked to ensure diversity in manufacturing locations across the portfolio of vaccines procured,” said EDB.

Arrangements for back-up airlift were also put in place to guard against limited global air cargo capacity, it said.

READ: Britain faces isolation as world tightens borders to keep out new COVID-19 strain

READ: WHO says no need for major alarm over new COVID-19 strain

ASSEMBLING THE TEAMS

The arrival of Singapore's first COVID-19 vaccine has been long-awaited, providing hope for an end to a global pandemic that has infected more than 77 million people and claimed 1.7 million lives.

Even before COVID-19 cases spiked to the thousands in Singapore, the search for suitable vaccine candidates had already begun.

In April, EDB chairman Dr Beh Swan Gin set up a therapeutics and vaccines expert panel (TxVax) led by Dr Benjamin Seet, deputy group CEO (education research) of the National Healthcare Group.

The panel comprised 18 scientists and clinicians across hospitals, A*STAR and the private sector.

Its mission was to source for promising vaccine candidates around the world.

There have been about 160 candidates to date, and the panel whittled that down to 35 after screening through technology type, track record and the timeline of production. 

Once certain vaccines and therapeutics showed promise, the Government set up a planning group to procure them early, said EDB.

The multi-agency group comprised members from EDB, the Health Ministry, the hospital cluster, the Health Sciences Authority and the Prime Minister’s Office.

It studied the TxVax panel’s analysis to shortlist promising candidates, which cut across different vaccine technologies.

READ: Singapore can be air cargo hub for COVID-19 vaccines - Changi Airport, CAAS

PROCUREMENT PROCESS

Three vaccines soon looked viable - Moderna, Pfizer-BioNTech and Sinovac. The first two vaccines use the new messenger RNA technology. Sinovac is a traditional inactivated virus vaccine.

mRNA vaccines teach our cells to make a protein that triggers an immune response inside our bodies. This is different from traditional vaccines that put a weakened or inactivated germ into our bodies.

The group made its first advance purchase agreement with Moderna in June, securing it with a down payment. In August, it bought the Sinovac vaccine and advanced talks with Pfizer-BioNTech.

Though Moderna appeared to be the frontrunner, the US Food and Drug Administration gave its stamp of approval to the Pfizer-BioNTech vaccine earlier, on Dec 11.

Singapore followed suit, with Prime Minister Lee Hsien Loong announcing in a televised address on Dec 15 that the Health Sciences Authority had approved the Pfizer-BioNTech vaccine.

The first shipment would arrive by the end of December, with other vaccines expected to arrive in the coming months, said Mr Lee then.

He also said that if everything went according to plan, Singapore would have "enough vaccines for everyone" by the third quarter of next year.

READ: Pfizer-BioNTech, Moderna and Sinovac - A look at three key COVID-19 vaccines

The road to Singapore's vaccine procurement was fraught with uncertainty, as decisions had to be made during early phases of clinical trials, said EDB.

“When we were at the point of negotiating the product, we had no idea if it was actually going to be licensed,” said EDB’s Dr Lisa Ooi, vice president, healthcare and wellness.

“It had to be accompanied with a risk-adjusted approach. For example how much do we buy, at what point, what data will allow us to make certain decisions. So all the decisions were made on a very data-driven process where we reviewed the data around the vaccines.”

While EDB started by establishing wide contact with vaccine makers, MOH negotiated and finalised commercial agreements.

"In advance purchase agreement, you're trying to buy something before the products are actually available. It’s almost like buying a movie ticket even before the reviews come," said Dr Seet.

"Subsequently we have to look at how soon we can actually get it into Singapore. If we want to buy, is it available? Because it could actually be bought up by bigger jurisdictions - the US, EU, many of the larger economies have bought huge chunks,” he added.

Once a candidate was identified, it was subject to HSA’s independent approval.

To date, Singapore has signed about 40 non-disclosure agreements with pharmaceutical firms, which grants it access to unpublished data. That allows authorities to make a more informed decision on the vaccines.

READ: Singapore to start Phase 3 of COVID-19 reopening on Dec 28

SAFETY OF VACCINE

The Government has not disclosed the amount of Pfizer-BioNTech vaccine doses it has ordered, but said this is the first time it has bought large quantities of a drug before approval.

Dr Seet explained: “We evaluated all vaccine technologies. But we eventually looked at RNA with a lot more interest, particularly because they were easier to manufacture and therefore went into clinical trials earlier and can actually be made available globally in the large quantities needed.”

Assoc Prof Tan Say Beng, executive director of the National Medical Research Council, said the standard of clinical trials also gave Singapore confidence to forge ahead.

"Globally, many agencies in countries are confident that the process was abided to. It was not at the risk of compromising the integrity of the study, so if you needed 30,000 subjects, you will get 30,000 subjects. So there were no shortcuts from that point of view."

COVID-19: Social gatherings of up to 8 people allowed from Dec 28, further reopening of activities in Phase 3

Singapore has set aside more than S$1 billion in the vaccine efforts, of which down payments have been made to at least three firms.

While it has not revealed the actual cost of each deal, authorities say Singapore's economic strategies gave it an edge during the talks.

“Singapore is really known as a leading biomedical hub, so I think the region does look to Singapore for certain thought leadership whether it's in regulatory, in clinical sciences," said EDB’s senior vice president and head of healthcare and wellness, Ms Goh Wan Yee.

"That position, plus the fact that many companies actually have significant bases in Singapore, puts us in a good footing to be able to negotiate and work with them despite our small market size,” she added.

To shore up the country's pandemic response, EDB also worked with companies to set up vaccine production facilities here.

With the shipment now in Singapore, the work to inoculate residents will begin.

The Government has said that vaccinations will be voluntary, but has urged residents to get inoculated.

Priority will be given to those at greatest risk, such as frontline and healthcare workers, and the elderly and vulnerable.

As the population gets inoculated, a rolling review will continue to track data from the vaccine.

"As the drug is being used in the population, not just in Singapore but around the world, the company has the requirement to track any adverse events it spots. It works closely with the regulator, HSA in this case, to make sure that they monitor, have a registry if you like, all the different side effects that they see,” said Assoc Prof Tan.

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2020-12-22 10:06:59Z
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