@ Cynthia Adina Kirkwood
U.K. Panics: Vaccine Rollout Could Cost Lives
Updated: Jan 19, 2021
The queue of lorries on the M20 was several miles long at Dover port caused by its closure after France shut its border to the U.K. following its announcement of a variant of the novel coronavirus before Christmas. (Photo by AFP)
Miraculously, there are safe and effective COVID-19 vaccines less than one year after the pandemic. Regretfully, the journey from vaccine development and approval into the arms of Europeans is taking the long way around.
At the same time, a virulent strain of the novel coronavirus, which is 70 percent more contagious, has been discovered in the United Kingdom. Unsurprisingly, it has been detected in dozens of other countries.
“Mainland Europe stands out as a global vaccine straggler, certainly in the rich world,” according to The Economist (January 5). “America and Britain have already jabbed 1-2% of their populations; Israel, the world’s stand-out star, is now at 16%, according to Our World in Data, a website. In contrast, Germany has administered merely 317,000 jabs, or 0.4% of its people. France did not break the 1,000 mark until January 4th. The Netherlands is due to start its vaccination drive only this week.” Portugal had vaccinated 32,000 people as of January 3, according to SIC Noticias (January 6).
What to do?
The United Kingdom panicked and adopted an unorthodox approach.
It accepted former British Prime Minister Tony Blair’s suggestion of delaying the second dose of the two-dose vaccines. In “A Plan for Vaccine Acceleration” (January 3) by Blair’s Institute for Global Change, also examined are vaccine supply, sites, staffing and systemization. Other countries such as Denmark have followed suit while some such as Germany are considering it.
What is also different about Britain is that it is the first country to approve the Oxford/AstraZeneca vaccine. On December 30, 2020, The British Department of Health and Social Care accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) and gave the vaccine emergency authorization. The viral vector vaccine is 60 percent effective, with two doses. The Pfizer/BioNTech is the other vaccine that has been approved in the U.K.
All four U.K. chief medical officers supported delaying the second jab, according to i (December 31, 2020), which they said “will protect the greatest number of at-risk people overall in the shortest possible time and will have the greatest impact on reducing mortality, severe disease and hospitalizations, and in protecting the NHS (National Health Service) and equivalent health services.”
There have been mixed reactions to the radical change in Britain’s COVID-19 inoculation program. Even pharmaceutical representatives differed in their responses. Pfizer/BioNTech released a joint statement:
“The safety and efficacy of the vaccine have not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,” referring to a prime shot and a booster administered 21 days later of the 95 percent-effective vaccine.
“There is no data to demonstrate that protection after the first dose is sustained after 21 days,” reported Reuters (January 4).
A total of 41 Members of Parliament have written a joint letter to Health Secretary Matt Hancock and Nadhim Zahawi, a minister for business and industry who temporarily relinquished that post when placed in charge of the COVID-19 vaccine rollout, seeking clarity on the changes in the vaccine plan in 20 questions, according to BBC News (January 4).
In it, the MPs said that they welcome the vaccine rollout and its prioritization of frontline health workers and the most vulnerable to the virus, but they ask whether the new 12-week gap between the first and second doses of the Oxford/AstraZeneca and Pfizer/BioNTech risks the success of the vaccination program. They also seek guidance on the combination of jabs from different manufacturers.
Professor Andrew Pollard, director of the Oxford Vaccine Group, said on Sky News (January 4):
“If you give a longer gap, the immune system has time to mature the response. You get a better response from the second dose. And if we have good protection from the first dose, as we know that we do with these vaccines, then you can give more vaccines to people if you’re not tripped up by having to give the second dose while you’re still rolling out the first dose.”
Pollard’s statement is not based on specific scientific data.
Scientists and doctors took different stances on the British plan.
Professor Wendy Barclay, of the Department of Infectious Disease at Imperial College London, said that spacing out injections was an interesting idea but “too risky” to try without further evidence, according to BBC News (December 23, 2020).
General practitioners (GPs) in the U.K. were angry with the government’s decision to delay the second dose to more than 500,000 people, according to i (December 31, 2020) because of the rescheduling nightmare. The chair of the British Medical Association’s GP committee, Dr. Richard Vautrey, said:
“It is grossly and patently unfair to tens of thousands of our most at-risk patients to now try to reschedule their appointments. The decision to ask GPs, at such short notice, to rebook patients for three months hence, will cause huge logistical problems for almost all vaccination sites and practices.
“For example, to make contact with even just two thousand elderly or vulnerable patients will take a team of five staff at a practice about a week, and that’s simply untenable.”
In 27 other European nations in the European Union, the Pfizer/BioNTech vaccine is the only vaccine, so far, to be approved by the European Medicines Agency (EMA). It is expected that the Moderna vaccine, also a two-jab vaccine, but the second inoculation given 28 days later, will be approved this week. The EMA recommended the Moderna vaccine for conditional market approval on January 6, according to DW (January 6). The European Commission is expected to approve it. Both the Pfizer/BioNTech and the Moderna vaccines are mRNA vaccines. The Moderna vaccine, if administered appropriately, has been proven to be safe and 94.5 percent effective.
The European Medicines Agency (EMA) said a maximum interval of 42 days between the first and the second shot of the Pfizer/BioNTech vaccine should be respected to obtain full protection, according to Reuters.
The EMA said that any deviation from its recommended spacing, without a change to its marketing authorization, would be considered ‘off label use’, which entails lower liabilities on vaccine makers, according to The Guardian (January 4).
Britain began inoculating people with the Oxford/AstraZeneca on January 4. Brian Pinker, an 82-year-old dialysis patient and retired maintenance manager, became the first recipient. The National Health Service released a statement in which he paid tribute to the scientists and said:
“I am so pleased to be getting the COVID vaccine today and really proud that it is one that was invented in Oxford,” said Pinker, who sat a few hundred meters from the laboratory, according to France 24 (January 4).
Perhaps, the British government is selling this vaccine to the public as a national triumph on the heels of its torturous break from the European Union on December 31. Nevertheless, nationalism is of no consequence here. The vaccine’s safety and effectiveness are what matter.
Dr. Jim Baker, Jr., a respected American immunologist wrote in his blog, Pandemic Pondering (December 31, 2020):
“The latest actions taken by the U.K. seem even more confusing. First, they approve the AstraZeneca vaccine well before anyone else took this action. While it was developed at Oxford University in the U.K., approving it at this point, given the paucity of data and the low rate of efficacy, still came as a surprise.
“As a reminder, the AstraZeneca vaccine showed only a 60% efficacy in a trial that had a number of errors, including an incorrect initial dose for a small portion of the trial. The company seized on that data since it seemed to show a much better protection rate in that group, although later analysis showed that it was not statistically different from the overall 60% protection rate.”
According to BBC News (December 14, 2020), the Oxford team “bristle at any suggestion that there was a mistake, error, call it what you will. Perhaps the most accurate characterization is that the volunteers were inadvertently given a lower dose. In months to come, they would be the stellar group in terms of vaccine efficacy.”
The first doses were made at Oxford’s own bio-manufacturing facility. As the trial grew, it was clear that the university’s small facility was inadequate. Therefore, the team outsourced some of the manufacturing to a facility in Italy.
The Italian manufacturer used a different technique from Oxford to check the concentration of the vaccine, which is how many viral particles are floating in each dose. When the Oxford scientists used their method, it appeared that the Italian vaccine was double strength.
“Calls were made to the medical regulators,” according to BBC News. “It was agreed that volunteers should be given a half measure of the vaccine, on the basis that it was likely to equate to something more than a regular dose. This was partly a safety issue – they preferred to give them too little rather than too much.
“But after a week, the scientists became aware that something unusual was going on. The volunteers were getting none of the usual side-effects – such as sore arms or fever. About 1,300 volunteers had only received a half-dose of the vaccine, rather than a full one. The independent regulators said the trial should continue and that the half-dose group could remain in the study.”
Therefore, in an initial press release, the vaccine was reported to be between 60 percent and 90 percent effective, depending on the first dose.
From the start, the team at Oxford wanted to create a vaccine that could help the world. To do so, they would need billions of doses, something that only could be provided by industry, reported BBC News.
Sir Mene Pangalos, of the Cambridge-based pharmaceutical giant, AstraZeneca, offered the company’s help.
However, Oxford insisted that the vaccine should be affordable, which meant no profit for the drug company. Professor Pollard said:
“Not usually the way big pharma works.”
BBC News reported that the two parties struck a deal at the end of April 2020.
“The vaccine would be provided on a not-for-profit basis worldwide, for the duration of the pandemic, and always at cost to low- and middle-income countries. Most importantly of all, AstraZeneca agreed to take on financial risk, even if the vaccine turned out not to work.
“In May, in a huge vote of confidence, the U.K. government agreed to buy 100 million doses and provided £90 million in support.”
Could it be that this non-profit vaccine’s commitment to global supply and equity as well as the British government’s financial commitment have clouded the judgment of experts? Add to that an amazing increase in COVID-19 infections, in part, due to a new highly contagious variant in Britain and the cheapness of the Oxford/AstraZeneca vaccine (£3 or $4 per dose as compared with £15 or §20 for Pfizer’s and £25 or $33 for Moderna’s), and the Oxford/AstraZeneca vaccine gets emergency approval in the U.K.
“The actual efficacy of one dose of the AstraZeneca vaccine is unclear and is open to debate,” said Baker in Pandemic Pondering. “Professor David Salisbury, a former director of immunization at the Department of Health in England, backed the idea claiming one dose of this vaccine will be 70 percent effective – which is crazy since that number is better than two doses were in the AZ trial!
“Most importantly, there is no data to show that the second dose of the Pfizer vaccine will be as effective if given three months later. This could reduce the overall efficacy of the Pfizer vaccine from the remarkable 95% shown in their phase three clinical trial.
“The implications of a vaccine that’s only 50-60% effective are far greater than people realize. Symptomatic infections continue to occur in people vaccinated with a 60% effective, albeit at half the current rate. This was well demonstrated in AstraZeneca’s clinical trial data. It means that this approach will not stop COVID-19 infections and transmissions. It may not even reduce the number of sick people that seek medical care. It seems poorly conceived at best.
“If the U.K. really wanted to help vaccinate the world more rapidly and effectively, they might consider having AstraZeneca license either the Moderna or Pfizer vaccines to increase production rather than trying to improve their own marginal product.”
Much has been made of the less cold temperature requirements for storage and transport of the Oxford/AstraZeneca vaccine as compared with the Pfizer and Moderna vaccines. Reuters (December 4) compared the three:
“The AstraZeneca vaccine can also be transported and stored at normal fridge temperatures, which proponents say would make it easier to distribute – especially in poor countries.”
Is this true? No. Chances are that if there is limited capability for storage in freezing temperatures, there is probably limited capability for refrigeration. “Poor countries” seem to refer to the Southern Hemisphere and a hot climate.
“The Moderna vaccine is stored at minus 20 degrees Celsius (-4 F), but can be kept for a month at normal refrigerator temperatures.
“The Pfizer vaccine needs to be stored at minus 70 degrees Celsius (-94 F) or below – equivalent to an Antarctic winter. . . . The vaccine will degrade in five days if kept at regular refrigeration temperatures of slightly above freezing.”
The German Health Ministry said that the European Medicines Agency’s rolling review of the Oxford/AstraZeneca vaccine was proceeding at “high pressure”, according to Reuters (January 4). In a rolling review, EMA’s human medicine’s committee (CHMP) reviews data as they become available. Therefore, CHMP can sooner reach its decision on authorization, according to the European Medicines Agency.
The Lancet (December (8) reported that the study of the Oxford AstraZeneca vaccine showed strengths, “including the large sample size, randomization to vaccine groups, inclusion of diverse sites targeting different races and ethnicities, standardization of key elements between the trials, balance of participant characteristics between the vaccine groups, inclusion of all participants in the safety assessment, and having similar results in Brazil as in the U.K. for the SD/SD (standard doses) group, which lends credibility to the results . . . .
“The limitations include that less than 4% of participants were older than 70 years of age, no participants older than 55 years of age received the mixed-dose regimen, and those with comorbidities were a minority, with results for that subgroup not yet available. The heterogeneity in vaccine dosage was fortuitous in uncovering a potentially highly efficacious formulation but was unplanned, and needs further evaluation in older adults and to confirm the unexpected results.”
BBC News (December 14) explained the science behind the Oxford/AstraZeneca vaccine:
“It is created from a modified virus that causes the common cold in chimpanzees, which has had a tiny bit of genetic material removed so that it can’t trigger infection in humans. Into this gap is inserted a fragment of the genetic code for coronavirus. This forms the vaccine. The technical term is a viral vector vaccine.”
Both the Pfizer/BioNTech and Moderna vaccines use a new technology, known as messenger RNA (mRNA), which has been researched for decades. The COVID-19 vaccine is the first product using this technology to be approved for use.
To trigger an immune response, many vaccines, such as the flu shot, put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, they teach our cells how to make a protein – or even just a piece of a protein – that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our body, according to the U.S. Centers for Disease Control and Prevention.
On January 3, India followed Britain’s example. It approved the Oxford/AstraZeneca vaccine for emergency use.
BBC News (January 4) reported that British Prime Minister Boris Johnson said that the U.K. has been “the first country to have pioneered a room temperature vaccine” in the Oxford jab, which he said offered “real hope for the future” and a “way forward”.
No, no and no.