Is the first come first served vaccine rollout scientifically and ethically right?

This narrative may not go down very well with the many young Malaysians who have successfully secured their AstraZeneca-University Oxford (AZ) doses.

I It was a frantic scrambling by the tech savvy for the 268,000 doses of the AZ vaccine. All vaccine doses were snapped within a space of four hours.

Now that they have jumped the queue, some of them have even begun to rationalize the legitimacy of the first come first served vaccine roll out!

A man receives the AstraZeneca Covid-19 vaccine at the World Trade Centre Kuala Lumpur May 5, 2021. ― Picture by Ahmad Zamzahuri

Due to the limited supplies of vaccines, like all other global health authorities and agencies, the MOH and JKJAV phased the vaccine rollout based on three major considerations.

  1. To protect and preserve the functioning of our society, namely the healthcare and essential services
  2. To decrease serious COVID disease and deaths by as much as is possible
  3. Reduce the added burden of COVID disease on people facing disparities

These considerations are premised on 4 major ethical principles:

  1. The allocation of the scarce vaccine supplies should aim towards maximizing the benefits and minimizing the harms. The reduction of COVID associated morbidity and mortality, would reduce the burden on the healthcare capacity. The most vulnerable in terms of inevitable work exposure and the other high-risk groups for COVID should be determined by scientific evidence.
  2. To promote justice to advance equal opportunity for all persons to enjoy maximal health and wellbeing as vaccines becomes more widely available.
  3. To mitigate health inequities and allow every person the opportunity to attain his or her full health potential and is not disadvantaged due to any social determinants.
  4. To promote transparency in the decision-making process to inspire public trust in the implementation of the vaccine rollout.

Pivoting on these incontrovertible principles, during the period of limited vaccine supply, the MOH and JKJAV has identified 5 major groups:

  1. Healthcare Workers
  2. Critical and Essential Services Personnel
  3. Senior Citizens
  4. Person with Co-Morbidities
  5. Physically and Intellectually Challenged Persons (OKU)

One does not sacrifice pristine ethical values simply based on a perception that there is “public fear over the AZ vaccine” because “we understand that is what the public feels”. [1]

Where may I ask is the scientific evidence to substantiate this personal perception? From the very outset, there has always been a substantial proportion of the citizens who have been either vaccine hesitant or resistant. (Graph I). This has remained fairly consistent for the period Dec-Feb 2021 (Graph II)

Graph I: Malaysians’ acceptance of COVID- 19 Immunization.
Graph I: Malaysians’ acceptance of COVID- 19 Immunization.
GRAPH II: Malaysians agreeable to be immunized against COVID- 19 for the period Dec – Feb 2021
GRAPH II: Malaysians agreeable to be immunized against COVID- 19 for the period Dec – Feb 2021

The FDA paused the J&J vaccine (adenoviral vector mode of action like the AZ vaccine) for 10 days to investigate the possible link with blood clots.[2] Unlike JKJAV, they undertook a 50 state COVID survey which showed that:

  1. There was high awareness of the J&J vaccine pause
  2. Vaccine hesitancy and refusal did not increase
  3. The pause did not have any major negative effects on vaccine preferences and attitudes

During the period Dec 2020 – April 2021, when the AZ and J&J vaccines were being investigated, except for the UK, overall, there was no decrease in vaccine acceptance in 8 European countries [3]

It would seem that the scientific studies and surveys do not validate the presumptions of the MOH or the JKJAV. But if they insist that the socio- demography of the vaccine hesitant/resistant persons in Malaysia are diametrically different from their fraternity in the US and 8 other European countries, then they ought to provide us with the evidence.

The CDC and FDA paused the use of the J&J vaccine, following reports of 6 cases (1 fatal) of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, on 13 April 2021 and promptly issued a health alert. [4]

The Advisory Committee on Immunization Practices (ACIP) met the following day, illustrating a sense of urgency to investigate the association of the J&J vaccine with the blood clots aka Thrombocytosis Thrombocytopenia Syndrome (TTS).

Within ten days, the ACIP presented its findings and recommended to the CDC to lift the pause on the J&J vaccine for use in adults.

We are made to understand that there was an assessment committee to review the AZ vaccine, its plausible association with TTS and its utilization in the Malaysian context. We would appreciate if the MOH or JKJAV can point us to the conclusions of the study and its recommendations. This is in part fulfillment of the ethical principle of transparency and accountability which would inspire confidence among the medical associations and professionals that a thorough analysis of the evidence has been undertaken and contextualized for PICK, National COVID-19 Immunization Program.

This would then facilitate an appropriate and comprehensive risk communications about the AZ vaccine. Some felt that this effort was not forthcoming from the nation’s highest health and vaccine authorities.

An individual who actually took the initiative to frame “KEY FAQS-A set of crucial questions you may want answered before deciding to opt in or out of the AZ vaccine” wrote in his twitter preamble “the health ministry couldn’t have been sloppier by just dumping a page of links at us.”

So what is the scientific and ethical basis for the MOH and JKJAV to offer the AZ vaccine “on a first come, first served basis to the public aged above 18 who are willing to have it”? [1]

Britain has the largest experience with the AZ vaccine. More than 50 million doses have been utilized, a substantial proportion of which were AZ doses. [5].

Following the 1st dose of the AZ vaccine in the elderly population, 90% of COVID associated hospitalization had been reduced. One can clearly see from Figure I, that the UK Joint Committee on Vaccination and Immunization prioritized the age group more than 65 for the AZ vaccine doses.

FIGURE I: Rollout of the Pfizer and AZ vaccines in Scotland.
FIGURE I: Rollout of the Pfizer and AZ vaccines in Scotland.

And for the four months period from Dec 2020 – Mar 2021, the Public Health England estimated that 10,400 deaths have been prevented in persons above 60 years old in England. [7] The high Vaccine Efficacy claimed in the clinical trains have now been vindicated in the real world experience.

With access to probably the largest data-set for the AZ vaccine rollout, the UK Joint Committee on Vaccination and Immunization, recommended, “based on available data and evidence, it was preferable for adults aged under 30 with no underlying conditions to be offered an alternative to the AZ vaccine where available” [8]

How does the MOH and JKJAV scientifically and ethically justify the AZ vaccine to young adults from 18-30 years old, considering that the UK with the largest and widest experience with it’s homegrown University of Oxford vaccine has advised otherwise?

An interim risk benefit analysis of the AZ vaccine and TTS can be accessed here. [9]. It references the European Medicines Agency (EMA) which has meticulously analyzed the data to stratify the very rare risk of blood clots with the benefits for different age groups and COVID incidence rates. [10]

Table I : Summary of cases per 100 ,000 persons after 1 dose of AZ vaccine in a HIGH Infection Rate Country

The 4-5 per million often touted is actually the risk of blood clots in persons beyond 70 years old as per the EMA analysis. The risk is actually 4 times higher in persons below 50 years of age i.e. 20 per million.

The risk of being admitted to hospital and of dying from COVID in a 70 year old is 1786 and 906 times respectively, when compared to the risk of suffering from a blood clot.

Thus my suggestion to prioritize the AZ vaccine rollout in the high infection rate states, namely Sarawak, Kelantan, KL and Selangor, with the first right of refusal to the groups at the highest risk of severe COVID disease and deaths, i.e. those above 60 years old. Only when these high-risk elders have been protected, then the AZ vaccine can be offered to others. This makes medical sense and it is the ethically right response, within the context of limited vaccine supplies and the presently known risk benefit analysis.

It is probably the less than impressive odds in the younger age groups that have persuaded many health authorities in European countries to reserve the AZ vaccines for those beyond 50 years old. [11,12,13] Unless the MOH and JKJAV has evidence to the contrary, the deluge of young would be vaccinees may precipitate a more than usual load of life threatening TTS into our already overwhelmed healthcare facilities.

By : Dr Musa Mohd Nordin MALAY MAIL

* This is the personal opinion of the writer and does not necessarily represent the views of The Stringer.

References:

  1. https://www.theedgemarkets.com/article/astrazenecca-vaccine-dropped-covid19-immunisation-programme-says-khairy-jamaluddin
  2. https://emergency.cdc.gov/han/2021/han00442.asp
  3. https://osf.io/j5hf2/
  4. https://raw.githubusercontent.com/mariefly/HOPE/master/The_Development_in_Vaccine_Acceptance_20210421.pdf
  5. https://www.bbc.com/news/uk-51768274
  6. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00677-2/fulltext
  7. https://www.gov.uk/government/news/covid-19-vaccines-have-prevented-10-400-deaths-in-older-adults
  8. https://www.reuters.com/world/uk/britains-medicine-regulator-says-identified-possible-side-effect-2021-04-07/
  9. https://fimaweb.net/astrazeneca-risk-benefit-analysis-of-vaccines-versus-blood-clots/
  10. https://www.ema.europa.eu/en/news/astrazenecas-covid-19- vaccine-benefits-risks-context
  11. https://www.dw.com/en/germany-restricts-use-of-astrazeneca-vaccine-to-over-60s-in-most-cases/a-57049301
  12. https://www.theguardian.com/world/2021/mar/19/france-limits-astrazeneca-covid-jab-to-over-55s-despite-ema-green-light
  13. https://www.ft.com/content/3dd76041-d8ac-4465-99a5-4569e8b9706e

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s