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Medisina at Politika by Dr. Rey Pagtakhan  

COVID-19 is a vaccine-preventable disease

by Dr. Rey Pagtakhan

      Ottawa Hospital handout
 
Nurse Venus Lucero administers the Pfizer-BioNTech COVID-19 vaccine at The Ottawa Civic Hospital, December 16, 2020. – Photo handout from The Ottawa Hospital

January 1, 2021. Joy to the world! How exciting it is, indeed, to know that Canadians, Americans, Britons and citizens of the European Union (EU) and 15 other countries have begun their mass immunization against COVID-19 to curb the unrelenting increase of new cases and deaths from SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2). The successful launch of this immunization drive before 2020 ended makes realistic the prospects of ending the acute pandemic before the end of the new year. Thanks to the regulatory agencies, the timely issuance of emergency use authorizations (EUA) have allowed the prompt arrival of both the Pfizer-BioNTech and Moderna COVID-19 vaccines. Already, members of the most vulnerable seniors and frontline workers have received the first of the two-dose intramuscular jabs to end the COVID-19 pandemic.

Shots of hope

“Shots of Hope” wrote science-writer Jon Cohen in an essay on the two vaccines for the magazine, Science. He chronicled the evolution of the pandemic from its start in December 2019 in China before its causative virus was identified and the new disease fully characterized, and before their scientific and medical names were formalized. He wrote of his daily phone conversations with his 90-year-old mother who went through a period of denial before agreeing to shelter-in, repeatedly asking, “When is this going to end?”

With that as background, Cohen then traced the search for vaccines after the pathogenic virus was identified on January 8, 2020 and its genetic sequence posted online by the Chinese scientists two days later. Apparently, the search for vaccines started within hours of January 10. He noted the “confluence of forces” that propelled science to two COVID-19 vaccines at breakneck speed with several more nearing completion of their Phase III clinical trials. He noted, “never before have governments, industry, academia, and non-profits thrown so much money, muscle, and brains at the same infectious disease in such short order.”

Overwhelming yet cautious optimism

Indeed, what a joyous feeling; to end 2020 and begin 2021 with overwhelming optimism. I never imagined the vaccines would be realized this soon. Although, I have prayed like others since I wrote the first part of this series for the February 1, 2020 issue to alert and inform our community and readership. Public health is now served with two vaccines – a twin set of biomedical tools with 95% efficacy and without concern of serious harm. Truly a scientific breakthrough!

Although we temper our optimism, I trust there will be no breakdown in the manufacturing supply chain. We remain confident that any unexpected serious adverse event will be fully investigated with dispatch. In fact, the U.S. regulatory agency convened a panel of experts last week to analyze and discuss a reported case of severe allergic reaction in one recipient.

The current situation

The launch of mass vaccinations is timely. Globally, the half-month increase in the total diagnosed came to over nine million cases. That is an average of over half a million cases daily and the total cumulative mark has surpassed the 80-million mark. Deaths increased by 10 per cent – a total daily average of over 10,000 (See the table below).

Compared to the global figures, Canada showed a half-month increase of over 90,000 cases. That is a total daily average of over 6,000. Deaths increased by almost 12 per cent – a daily total average of over 100.

For the U.S.A., the half-month increases in both cases diagnosed and deaths were similar in magnitude to that of Canada. The increase in cases and deaths for the Philippines over the same half-month period was considerably less in magnitude. We need to stop the continuing circulation of the virus.

Location

Total Cases

Total Deaths

Number

Increase (% )

Number

Increase (% )

 Worldwide

80,587,536

9,238,028 (12.95%)

1,761,749

161,530 (10.09%)

 Canada

549,342

94,220 (20.70%)

14,892

1,576 (11.84%)

 USA

19,031,403

3,119,783 (19.60%)

332,502

36,397 (12.29%)

 Philippines

469,886

21,555 (4.81%)

9,109

379 (4.34%)

Cumulative cases and deaths including the half-month increases since December 12, 2020
Data from the Johns Hopkins University Coronavirus Tracker, December 27, 2020

Overall, the figures remain alarming. Compliance with public health restrictions has become increasingly difficult. The feeling of helplessness among all concerned – families, communities-at-large, frontline health care workers, students, public health officials, businesses, and governments at all levels – appears clearly palpable.

What a change in feelings, indeed, when we heard about the vaccines being given the green-light for emergency mass vaccination. As discussed in the last issue, I chose to comment on the first vaccine – from Pfizer-BioNTech – in more detail to emphasize the meticulous care applied to its rigorous evaluation and the strict criteria used by the regulatory agencies in Canada, Britain and the USA. To enhance public confidence in vaccines by public transparency, the U.S. Center for Biologics Evaluation and Research has published master protocols for SARS-CoV-2 (the COVID-19 virus) vaccine safety and effectiveness evaluation. Speed in approval was achieved without any short cuts. The regulatory agencies through their panel of experts have seen to it that safety and efficacy are paramount.

Comparison of vaccines

Two weeks before Christmas, the U.K. government announced that the developers of the Oxford-AstraZeneca vaccine had submitted their application for authorization to the Medicines and Healthcare products Regulatory Agency (MHRA). Approval is expected on January 4, 2021. With comparable levels of efficacy and safety and with having the advantage of lower cost and less onerous demands on transport and storage, the third vaccine would certainly boost the earlier two. More than 700 million doses are expected by the end of the first quarter of the new year.

Meanwhile, let us compare the Pfizer and Moderna vaccines. Like the Pfizer, Moderna’s vaccine delivers messenger RNA, or mRNA, which is a “genetic recipe for making a piece of the spikes that sit atop the coronavirus.” Once injected, the body’s immune system makes antibodies to the spikes. If a vaccinated person is later exposed to the COVID-19 virus, the person’s immune system is fully prepared to attack the virus.

We do not know how long protection will last following vaccination but it will be critically important to measure long-term protection (at least two years) in the phase 3 trials and in other groups prioritized for early vaccination. We are still learning about the duration of protection following infection with SARS-CoV-2 and it is too early to tell how long protection will last.

The two vaccines are of the same type, have similar efficacy levels, but do have slightly different makeup in their lipid delivery systems. That difference explains why they have different storage and handling features. Unlike Pfizer’s vaccine, Moderna’s vaccine does not have to be kept in a super-cold environment. It can be kept at about minus 20 degrees Celsius, or about the temperature of a home freezer. Moderna’s vaccine can also be kept in a refrigerator for 30 days before it expires. That makes it more manageable in terms of distribution to outlets.

Moderna’s vaccine is administered as two 100-microgram doses given 28 days apart. Pfizer’s vaccine is administered as two 30-microgram doses given 21 days apart to recipients as young as 16 years old. For Moderna, the lower age range is at 18. The two share the same spectrum of transient side effects.

Side effects observed with the two vaccines

The table on this page summarizes the side effects and the frequency of their occurrence with the two authorized vaccines in Canada. Although I have listed them in one table, I should note, as remarked in the fact sheets for the vaccines, that “because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.”

Adverse reactions observed during clinical trials of COVID-19 vaccines

No.

Side Effects

Frequency of
Occurrence (%)

Pfizer/BioNTech

Moderna

 1

 injection site pain

84.1

92.0

 2

 tiredness/fatigue

62.9

70.0

 3

 headache

55.1

64.7

 4

 muscle pain

38.3

61.5

 5

 chills

31.9

45.4

 6

joint pain

23.6

46.4

 7

 fever

14.2

15.5

 8

 injection site swelling

10.5

14.7

 9

 injection site redness

9.5

10.0

 10

 nausea

1.1

23.0

 11

 feeling unwell/malaise

0.5

 12

 swollen lymph node
 (lymphadenopathy)

0.3

19.8

Additional notes on safety, precautions and contraindications

  1. There is a remote chance that either of these COVID-19 vaccines could cause a severe allergic reaction which, if it were to occur, usually occurs within a few minutes to one hour after getting a dose of the vaccine.
  2. Such reaction could include a bad rash all over the body, dizziness, weakness, fast heartbeat, swelling of face and throat, and difficulty breathing. These need emergency attention.
  3. Health Canada has, in fact, recommended that anyone who is allergic to any of the ingredients should not receive the vaccine. It also advised that anyone who has had a serious allergic reaction to another vaccine, drug or food, should talk to their health professional beforehand.
  4. There are no data available on the interchangeability of the Pfizer BioNTech COVID 19 Vaccine or the Moderna with other COVID 19 vaccines to complete the vaccination series. Individuals who have received the first dose of the vaccine should receive a second dose of the same brand to complete the vaccination series.

Scarcity and allocation of vaccines

Even with the Oxford/Zeneca and other additional candidate vaccines in the pipeline, there won’t be enough for the general population until spring, and doses will be allocated to groups based on degree of vulnerability to COVID-19. Apparently, Canada was on track to receive 1.2 million doses of both vaccines by the end of last month. The vaccination campaign for the general population will begin in April. These are Canada’s vaccine orders to date, including options:

  • Pfizer – Up to 76 million doses (minimum of 20 million doses for delivery in 2021.)
  • Moderna – Up to 56 million (Canada has so far agreed to purchase 40 million doses.)
  • Medicago – Up to 76 million
  • AstraZeneca – Up to 20 million
  • Johnson & Johnson – Up to 38 million
  • Novavax – Up to 76 million
  • Sanofi and GlaxoSmithKline – Up to 72 million
  • International COVAX Facility – Up to 15 million

Major General Dany Fortin, the commander in charge of Canada’s vaccine logistics, said the distribution last month of the Pfizer vaccine had gone smoothly. The provinces and territories have largely adhered to the guidelines released by the National Advisory Committee on Immunization. Long-term care and retirement home residents and staff, the elderly, front line health care workers and some Indigenous adults are in the first phase of distribution.

Considering the global supply, it is understandable to have scarcity. Obviously, continued expansion of vaccine manufacturing capacity and availability of other vaccines are needed to meet demands, including global access. Meanwhile, we shall continue to include patience as a principle in addition to the principle of equity.

Diversity and inclusion of minorities in vaccine trials

It is gratifying to note that, from the viewpoints of both public health science and social justice, participants in the clinical trials of the two COVID-19 vaccines that have received emergency use authorizations in Canada, the United States, the United Kingdom, and the 27-nation bloc of the European Union have included representations from minorities. They have included Black, Latinx, and indigenous communities when the trials were undertaken in the United States.

Why, indeed, do diversity and inclusion matter in these vaccine trials? Dr. Michele Andrasik at the University of Washington and Dr. Chris Beyrer at the Johns Hopkins Bloomberg School of Public Health have shared the following key points in their blog series:

  1. Minority communities, particularly Black, Latinx, and indigenous communities, have been particularly hard hit by COVID-19 in the United States as a consequence of high rates of virus transmission, that is, the “force of infection” becomes a major consideration as discussed below.
  2. These communities also share a legacy of abusive policies and practices, creating social and economic circumstances compromising community health and well-being and fostering mistrust in COVID-19 vaccines; and
  3. Participation of these communities in COVID-19 vaccine trials is thus of critical importance to ensure vaccine efficacy in the face of intense virus transmission and to build trust in the vaccines.

At one point, the Moderna trial was purposely slowed down to allow for greater recruitment from among these minorities.

“Not because of possible genetic differences,” I underscore, but because the “force of infection” – the epidemiologic risk of exposure to and acquiring the COVID-19 virus – is so much higher for these communities due to their daily life and living circumstances. That is, their housing, the transport they to take to work, the type of jobs they have, the inequalities in health care they receive or lack of them).

Andrasik and Beyrer observed that the early phase of vaccination would be marked by a “scarcity of vaccine and by a complex set of challenges around allocation, access, and equity.” How should those from ethnic and racial minority communities be included in the allocation framework? What would be the level of their willingness to be immunized if they had not been as engaged during the trials? Their uptake could be markedly lower.

Conceivably, their direct participation in the clinical trials could provide vital information for comparative efficacy of certain specific vaccine types relative to others in light of the greater force of infection in these communities, and not about racial or ethnic differences in biology. Also, their participation would help lessen mistrust of research results with which they have been part of. A feeling of fulfillment engenders public trust in health delivery, especially in public health.

On the vaccine-hesitant, skeptics and antivaxxers

Last year, the World Health Organization identified vaccine hesitancy as one of the top 10 threats to global health. The problem has remained in some parts of the world. In Russia, even medical doctors hesitate. In Canada, nearly half of our eligible population are eager to receive their dose as soon as it’s available. About 15 per cent are a definitive “nay.” Are these the diehards? While it is truly difficult to fathom why some would remain mistrustful of the 95 per cent efficacy vaccines without concern of serious harm, we still ask ourselves, “How shall we react?”

Respect their viewpoints, I say, and understand the situation. Perhaps, they have wounds from the self-serving narratives from some of our political leaders. Perhaps, they do not fully comprehend the reasons for the speed, not haste, with which the scientific and medical communities achieved what they did in so short a time. It was made possible by the long preparatory scientific research work done before, the collaborative efforts of research colleagues, the philanthropy from private donors, the partnership with governments, and the innovation on the part of regulatory agencies to evaluate research documents and submissions when applying for interim orders or emergency use authorizations for a vaccine product. All these have contributed to the accelerated work without compromising the integrity of vaccine development and clinical trials to ensure the safety and efficacy of vaccines.

A tincture of time is needed to heal the wounds. I have taught many youth aspiring to be medical doctors and shared medical advances with fellow physicians. I have attended to patients in intensive care units. I have made house calls. I have seen adults and children as patients. I have done both basic and clinical research. And I even served in appointive and elected public office as a second calling. I have done a lot of community volunteer work. I have come to understand human needs and nature, to some extent.

Accepting the gift of science and medical progress

I know that respect, tolerance, understanding, and time are essential to achieving our common goal. I trust all would welcome their COVID-19 jabs – two intramuscular injections in your arm, three weeks and four weeks apart with the Pfizer/BioNTech and the Moderna vaccines, respectively. We do not need a mandate from the outside, but we do need the mandate from inside us. And humanity will be forever grateful. It is pleasing to note, indeed, that the vast majority of Canadians are optimistic for life in 2021, in light of the arrival of the two vaccine products. May we all accept the gift of hard scientific work.

Says Dr. Dr. Larry Corey, Professor of Medicine and Virology at the University of Washington and Chair of the COVID-19 Vaccine Clinical Trials Working Group, “COVID-19 is a vaccine-preventable disease.”

Rey D. Pagtakhan, P.C., O.M., LL.D., Sc.D., M.Sc., M.D. – former cabinet minister and Parliamentary Secretary to Canada’s Prime Minister and retired lung specialist and professor – graduated from the University of the Philippines. He did postgraduate studies/training at Washington University and University of Manitoba and spent a sabbatical year as Visiting Professor at the University of Arizona. Author/co-author of chapters and papers for medical textbooks and journals, he writes the column Medisina at Politika for two Canadian Filipino community publications. Widely lectured, he spoke on the “Global Threat of Infectious Diseases” at the G-8 Science Ministers and Advisors Carnegie Group Meeting held June 13-15, 2003 in Berlin, Germany. reypagtakhan@gmail.com.

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