The Health | March , 2021

Instead of outright mass vaccinations of these frail and sick senior citizen population , perhaps we have to consider a more careful approach starting with smaller trial groups involving the elderlies , as well alternative strategies such as vaccinating the people around them , to form some sort of ‘ local bubble ’ surrounding these groups .

To understand why a careful approach could be valuable and why these particular groups may be excluded from vaccination , it ’ s important to firstly understand the context of these reported adverse events .

As reported by Rachael D ’ Amore in Global News , a virologist and assistant professor at Dalhousie University Alyson Kelvin mentioned the difference between adverse events “ following immunisation ” and adverse events “ directly related to vaccine ”.

Any calamities , such as death ( which could happen due to various reasons ) happening to the person after receiving the vaccine would be recorded as an adverse event . It doesn ’ t necessarily mean its related to the vaccine .

Looking at the case in Norway , D ’ Amore reported 33 deaths from the 45,000 people vaccinated with the Pfizer-BioNTech shot since mid-January , and these group of 33 people were described as a group of frail elderly individuals ( 75 years and older ) with serious diseases .

How does this number stack up with the clinical trials ?

According to the US Food and Drug Administration ( USFDA ) Briefing Document dated Dec 10 , 2020 , a total of six deaths out of 43,448 participants were reported . Only two of the six received vaccines while the rest were placebos . The two vaccine recipients were above 55 years of age .

Debate over the cause of dealth

So , the death rate reported by D ’ Amore for the Norway case is 0.073 % while the death rate reported in the clinical trial was 0.01 %. If we only consider the two participants that actually received vaccines , then the clinical trial mortality rate is about ~ 0.0046 %.

No deaths are insignificant but statistically speaking these numbers show a relatively small frequency compared to the total vaccinated group . Now with that being said , it does appear to show Norway ’ s figure to be nearly 16 times more than the clinical trials . There are various opinions on this observation .

According to Bloomberg Intelligence Senior Industry Analyst Sam Fazeli , “ Norway ’ s excessive deaths suggest they are in subjects with serious , uncontrolled illnesses .” Others may postulate that these individuals were nearing the end of their lives or could be part of the expected daily death rate in Norway ’ s nursing home . What is certain is that we ’ ll need more representative data to ensure that this is more demographically comparable .

Phase two and three of the clinical trials consist of only 21.4 per cent participants who are 65 years and older​ , with obesity ( 35.1 per cent ), diabetes ( 8.4 per cent ) and pulmonary disease ( 7.8 per cent ) as some of the most common underlying diseases . The document mentioned that it includes

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BY AMEEN KAMAL

“ participants with chronic but stable medical conditions ”.

In contrast , according to the Norwegian Medicines Agency , the Norwegian case involves “ the elderly and people in nursing homes with serious underlying diseases ” and postulated that “ therefore it is expected that deaths close to the time vaccination may occur ”.

A top physician at the Norwegian Medicines Academy , Sigurd Hortemo pointed that we cannot exclude the possibility of adverse reactions ( side effects such as fever , which are relatively more common ) undermining the already-deteriorating health of these highly vulnerable groups , which could have further contributed to more severe conditions and even death .

This could explain most of the 143 deaths shortly after vaccination in the UK , as reported in UK ’ s The Sun , whereby officials mentioned that “ the majority of reported fatalities were in elderly people or people with underlying illness .”

Optimising the vaccine “ value ”

All-in-all , clinical trial results indicate that the benefit to the overall population outweigh the risks , but in light of insufficient data to represent significantly older age groups with acute illnesses and / or unstable conditions , these emerging reports warrant a careful approach or a different strategy for these groups .

As mentioned earlier , a strategy to be considered could be vaccinating the people around them , to form some sort ‘ localised heard immunity ’ or ‘ local elderly bubble ’. For example , this could mean household members taking care of them or nursing home workers .

This method could satisfy proponents of “ quality-adjusted life years ” or QALYs per vaccine that advocates a method of prioritising vaccine recipients according to the relative ‘ value ’ or ‘ benefits ’ it brings to people receiving it ( according to extended lifespan and health condition improved through receiving vaccines ).

The vaccine ‘ value ’ is optimised through inoculating people who are more likely to experience higher QALY per vaccine whilst at the same time , these selected people can act as a ‘ bubble ’ to keep the frail and ill elderlies safe from Covid-19 infections - potentially mitigating QALY ’ s discriminatory impact against this clearly vulnerable groups .

Of course , this method assumes vaccinated people cannot transmit the virus , which may not be the case . Also , this concept carries operational challenges as it introduces new guidelines and standard operating procedures ( SOPs ).

Medical authorities would need to establish clear clinical criteria for determining age groups with certain illnesses to be excluded from vaccination , especially those deemed to be in the terminal stages . This is followed by the selection criteria and verification process for the people around them to form the ‘ bubble ’.

The method also requires strict adherence to SOPs to ensure the ‘ frail elderly bubble ’ isn ’ t breached , giving special importance of contact tracing surrounding this bubble . The method could mean more people than expected to be vaccinated in the second phase given that a frail and ill elderly individual may be surrounded by more than one person .

The second phase has been reported to involve 9.4 million people from the high-risk senior citizens groups , starting from April to August this year . At two doses per person , this translates to 18.8 million doses .

Smaller trial groups

As reported in Code Blue , a total of 21 million doses are expected to be received by the second quarter . That ’ s roughly 2.2 million ‘ extra ’ doses . Let ’ s say we are left with a ballpark figure of 1.5 million doses ( assuming buffer doses aside ) with two doses per person that ’ s already 750,000 people who could be considered for the ‘ frail and ill elderly local bubble ’.

These are just “ back of the envelop ”’ estimates and the authorities have to verify its viability , which would be subject to ( among others ) actual planned utilisation of the various vaccine types and actual vaccine inventory .

Similar calculations based on the reported three million vaccines doses expected in the first quarter and a first phase involving 500,000 frontliners indicate a similar number of additional doses in the first phase . If so , in addition to frontliners , the first phase should consider small trial groups involving the elderly , in various potential formats . Based on the results from the first phase , we ’ ll have more data to shape vaccine choices and strategies to be used for the larger senior citizen population in the second phase .

The concept of doing smaller trial groups involving different vaccines types in the first phase may also provide more data against uncertainties such as serious adverse events , immunity retainment , side effects and potential impact on vaccine effectiveness continuously-emerging mutated virus strains .

Many are asking to be prioritised vaccine recipients , but careful use of extra doses ( if any ) in an estimated one-year journey towards heard immunity will have to be in balanced consideration of the workforce in key economic sectors , the education system and selected workforce relevant to uncompromisable areas of national security . — The Health

Ameen Kamal is the Head of Science & Technology at EMIR Research , an independent think tank focused on strategic policy recommendations based on rigorous research .