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London. The cameras were focused on the face of 90 year-old Margaret Keenan, the first UK citizen to receive the newly approved Pfizer/BioNTech COVID-19 vaccine on Tuesday at University Hospital in the city of Coventry.  After her jab, she passed through a corridor of applauding nurses. Behind her mask was the glint of a smile as she described the experience as an “early birthday present”. She turns 91 next week.

But underneath the hopeful photo-ops, staged in England’s north, one of the areas hardest hit by the coronavirus, a technically complex “V-Day” operation was getting underway across the hospitals, and primary health care centers of the UK’s National Health Service (NHS).

"It's just so strange and wonderful really"

Margaret Keenan, who turns 91 next week, says becoming the first to receive the Pfizer/BioNTech vaccine is the "best early birthday present"https://t.co/5YRCcikgC8 pic.twitter.com/FxviG39ai2

— BBC Breaking News (@BBCBreaking) December 8, 2020

Famed for its octopus-like bureaucracy, the vaccine rollout could still be a model for other countries if it goes off smoothly as 800,000 vaccines are rolled out this month, to be followed by up to 4 million more vaccines in January 2021.

Some 50 hospital hubs around the country, with cold chain capacity to manage the -70C ultra-cold conditions required for the Pfizer vaccine, were the first to begin administering vaccines on Tuesday, according to a detailed NHS plan, that is to be executed with military-style precision.

In line with the recommendations of an independent expert group published just last week, the campaign will focus first on vaccinating people over the age of 80, as well as some of the most vulnerable health and care staff – particularly people working in care homes.

Health Secretary Matt Hancock dubbed Tuesday “V-day”. The term, hearkening back to the legacy of Britain’s World War II’s D-Day landing at Normandy, illustrated both the drama of the moment as well as the complex logistics required to successfully execute the vaccination operation.

“Today marks the start of the fight back against our common enemy, the coronavirus,” said Prime Minister Boris Johnson, on a visit to a London hospital where others were lining up to receive their first vaccine doses. He summoned national pride as well, declaring that getting vaccinated was “good for you and good for the whole country”.

Initiative Begins at Hospitals – Moving Next Week To Primary Care Networks

While the initiative was beginning at 50 hospital hubs across the country, there were also plans to distribute about one-fifth of the vaccines through about 280 pre-selected NHS ‘primary care networks’ (PCNs).

These PCNs are local health care centres that house clusters of NHS general practitioners who are the first point of care for patients’ routine healthcare needs in the state-sponsored NHS system. The PCNs will be expected to deliver around 945 vaccines in the 3 days after receiving a vaccine batch; they would also executive “roving vaccine” services to nearby care homes.

An exhaustive NHS circular on Monday outlined the steps that would be required for the vaccine campaign, in nitty-gritty detail, to those local practitioner centres

These steps ranged from details of the protocols for selecting and booking the first patients, to instructions about the drop-off of portable refrigerators to ensure adequate cold-chain storage for the sensitive Pfizer vaccines.

The PCNs must also perform a battery of assessments, reviewing the readiness of their site, supplies, workforce, IT systems and medical records, and how they plan to dispose of vaccine waste. Training webinars, a hotline and a process to request more vaccine supplies have also been set up.

The circular illustrated the special measures being put into place to handle the ultra-cold conditions required for the vaccines – and ensure their use rapidly after delivery. It read:

“A separate delivery of an under-counter sized refrigerator will be made to every site between Tuesday 8 th – Saturday 12th December. You will be given 24 hours’ notice before your delivery is made. Deliveries will be made between 08:00 and 18:30 on weekdays and between 09:00 and 16:00 on Saturdays,” the circular told primary care networks.

“We expect the remaining vaccine shelf life once delivered and stored at 2-8°C to be in the range of 86 hours (3 days 14 hours) to 99 hours (4 days 3 hours).”

On storing the vaccine, it said: “Shelf life will be clearly marked on the vaccine box label. Further guidance on the appropriate cold chain procedure can be found in the SOP. Note that it is essential that sites have sufficient vaccine storage space at 2-8 °C for up to 5 days.

“Sites that receive the initial vaccine delivery on 14 December will receive their corresponding vaccine delivery for dose 2 on Monday 4 January 2021. Sites that receive their initial vaccine delivery on 15 December will receive their corresponding vaccine delivery for dose 2 on Tuesday 5 January 2021.”

Ethnicity Also A Recommended Factor in First Vaccine Selections

The recommendations to GPs also include advice to consider placing older people who are members of an ethnic minority to go first in line.

“GP practices know their local populations and are responsible for generating patient lists based on the priority cohort definition, which for sites going live next week is ‘All those 80 years of age and over’ (excluding the housebound),” the circular clarified.

“If your site potentially has more than 975 patients over 80 years who may wish to be vaccinated, and you need to prioritise which patients should have access to the first supply of vaccine to your designated site, then you could consider the following: i. Age 80 or over; ii. Co-morbidities; iii. Ethnicity.”

That last recommendation is based on the Department of Health and Social Care expert group  findings that “certain black, Asian and minority ethnic groups” should also receive preferential vaccine treatment because they are at higher risk for serious disease. This risk is due largely to socio-economic inequalities, inequalities in access to health services, and related health conditions.

.@MartinRCGP has written to @MattHancock asking him to explain the rationale for not including Black, Asian and minority ethnic patients on #Covid19 vaccination priority list. Read more in @thetimes https://t.co/NnPUO7rlz2

— RCGP (@rcgp) December 2, 2020

“There is clear evidence that certain black, Asian and minority ethnic (BAME) groups have higher rates of infection, and higher rates of serious disease, morbidity and mortality,” the expert group report, published last week, stated.

“There is no strong evidence that ethnicity by itself (or genetics) is the sole explanation for observed differences in rates of severe illness and deaths.”

“What is clear is that certain health conditions are associated with increased risk of serious disease, and these health conditions are often overrepresented in certain BAME groups. It is also clear that societal factors, such as occupation, household size, deprivation, and access to healthcare can increase susceptibility to COVID-19 and worsen outcomes following infection. These factors are playing a large role in the inequalities being seen with COVID-19.”

Roll-Out Logistics Aside – The Public ‘Hearts-and-Mind Challenge’ Remains

Precise, considered actions – like those outlined above – coupled with close monitoring of vaccinated populations, are vital in ensuring the NHS gives a strong performance on the global stage this December, but the true challenge lies in public uptake, a professor of general practice in south west England told Health Policy Watch.

“The supply, the manufacturing, the distribution – these are all going to be very stretched,” said Professor John Campbell, Professor of General Practice and Primary Care at the University of Exeter Medical School. He said that despite the government’s assurance “that Brexit is not going to affect any of that, you can imagine getting this into the UK is going to be quite a challenge”.

The first batch of the Pfizer coronavirus vaccine left the manufacturing facility in Belgium on Thursday 4 December and was ready for use by Tuesday morning with no delays.

But the UK’s Brexit deadline of 31 January has also raised concern as to how quick and easy deliveries can remain after that date.

Even more pressing concerns, Campbell said, are not strictly logistical. While complications in the distribution and administering of a vaccine can be ironed out, “the bigger issues are related to the public perception and understanding of a new type of vaccine”, referring to the relatively novel mRNA technology used by Pfizer.

“There is a hearts-and-mind challenge for the wider public that we have to be sure to overcome,” he warned. “While people are desperate to get back to some sort of normality, people are still questioning [getting vaccinated].”

Both the UK and WHO have acknowledged the threat posed by a limited vaccine uptake by the public. WHO has published guidance for improving acceptance – and the UK’s Department of Health is also making patient engagement a key part of its package for primary care networks.

But there could be an equal threat growing in the opposite camp, Campbell underlined: among those who are willing to be vaccinated as soon as possible.

The other concern is that increasingly positive news of an imminent vaccine roll-out could urge the public to throw precautionary measures to the wind, despite the fact that most people will remain unprotected until a critical level of herd immunity is reached in vaccine coverage.

“People are now thinking that the new vaccine is around the corner,” Campbell noted. “Realistically, for the majority of the population, it’s going to be many months off.”

This was a fear that was shared by WHO last week, with WHO Director General Dr Tedros Adhanom Ghebreyesus warning last Friday: “There is a growing perception that the pandemic is over. The truth is, at present, many places are witnessing a very high transmission of the virus, which is putting enormous pressure on hospitals, intensive care units and health workers.”

Campbell said: “People have this sense that the vaccines are here so we don’t need anything else, and that’s very much not the case … It’s in this 6 to 9 month gap that there are important opportunities for other interventions.”

A Vaccine Can’t Come Too Soon

For most countries, weary of economic lockdowns, social strains, pressured hospitals, not to mention the human tragedies of serious illness, death and “long COVID” after effects, the introduction of vaccines cannot be too soon.

Over 1.5 million people have died since the pandemic began nearly a year ago, including more than 61,000 in the UK, the fifth hardest hit in terms of mortality, after only the United States, Brazil, India and Mexico – and just ahead of Italy, France, Iran, Spain and Russia. Many of those same countries are now in the thralls of a second or third wave of virus infections and deaths.

At a press conference on Friday, WHO officials held out hope that low- and middle-income countries, and more affluent ones, could begin vaccinating the highest-risk groups, like health workers and older people in the first quarter of 2021, with the support of the WHO co-sponsored Act Accelerator’s COVAX vaccine facility initiative.

Most of the world’s countries, rich and poor, have joined the initiative – which also aims to raise donor funds to supply 2 billion vaccines to countries that cannot afford to purchase them on their own.

However, despite repeated pleas to donors for support, the facility remains some US$28 billion short on the funding needed for next year to fully fund the vaccine drive, as well as drugs, tests and health system support services in the world’s poorest 92 countries.

Meanwhile, a parallel initiative by India and South Africa in the World Trade Organization to extend a “waiver” on COVID-related patents, copyrights, and trade secrets for vaccines, medicines and health equipment has picked up considerable support among African, Asian and Latin American member states. But it is stiffly opposed by a wall of G-20 countries with huge pharma interests at stake.

WTO members are due to meet again on Thursday to debate the waiver proposal – ahead of a full hearing by the WTO’s General Council on 17 December. While a number of high- and middle-income countries, including Canada and Australia, have tried to mediate a highly polarized debate, leaders of the initiative have also threatened to put it to a vote, if it’s not taken seriously.

Medicines access groups are now stepping up their campaign for approval of the WTO waiver – saying it’s the only way to ensure fair distribution of the brand-new technologies.

“While the world waits with bated breath for the possible approval of these COVID-19 vaccines, it’s not time to celebrate yet,” said Dr Sidney Wong, Executive Co-Director of Médecins Sans Frontières Access Campaign in a press release on Tuesday.

“Right now, we’re in a situation where a lion’s share of the limited number of first doses have already been snatched up by a handful of countries like the US and UK, as well as the EU, leaving very little for other countries in the short term. What we really want to see is a rapid expansion of the overall global supply, so there are more vaccines to go around and doses can be allocated according to WHO’s public health criteria, not a country’s ability to pay.”

Image Credits: Pfizer, BioNTech.