1 WHAT IS KNOWN AND OBJECTIVE
The first report by the World Health Organization (WHO) on the coronavirus, the cause of the infection now known as COVID-19, signalled the beginning of one of the most momentous epidemics in the history of mankind. The Coronavirus Study Group (CSG) of the International Committee on Taxonomy of Viruses classified and named the virus as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).1 Our objective is to comment on its highly infective Omicron variant and to suggest that while it may go on to overwhelm some health services and kill many, it may well contribute to a resolution of the current pandemic.
On 31 December 2019, the World Health Organization (WHO) reported on a cluster of cases of pneumonia in Wuhan, China. Soon after, Chinese investigators who made the discovery identified the causative virus as a new coronavirus.2, 3
The Omicron variant of the virus (or more simply and less alarmingly, variant O; the 15th letter of the alphabet, both Greek and English) is regarded as a serious threat because of its extreme contagiousness. Only a small proportion of infected patients needs to be hospitalized for most national health services to be overwhelmed, the dreaded outcome for all governments. To avoid this, many health authorities, including the UK National Health Service, have embarked on a campaign to boost vaccinate the whole of its eligible population. As some early evidence suggests that the vaccine is less effective against variant O,4 concern is spreading to a level that creates fear bordering on panic.4
I have worked on vaccines on and off for many years5, 6 and have previously served on the British Committee on Safety of Medicines. So, friends and relatives often ask me about drugs and health matters.
“I hear that the J and J vaccine which I have had as a booster is less effective,” one of my friends asked. I sensed his implicit worry that he might be at risk of catching the infection and dying as some of his acquaintances had during the first wave of the pandemic. “Is it true that those fully vaccinated are more likely to get infected with Omicron than those not vaccinated? How is this possible?” asked another.
That variant O is causing considerable concern is obvious, a concern that feeds on fake news and headlines of proper research, truncated more to grab attention than to convey nuances and uncertainties of the work reported. In the fast-changing world of COVID-19, discriminating between fake news and fact, and fact within headlined quality research, is increasingly difficult even for those actively involved in its research. A Medline search of the word “COVID” in the title brought up over 140,000 records by the middle of December 2021.
The history of vaccination goes back many centuries before the late eighteenth century when Benjamin Jesty and Edward Jenner noticed that milkmaids infected with cowpox, a mild disease, developed protection against smallpox, a disease that killed one in three of those affected.7 The Chinese had eight centuries earlier been practising variolation, a technique that involved taking small samples of pus from smallpox pustules, drying them and inoculating those not yet infected, intranasally.7 Later variolation would be more widely given intradermally. The technique of attenuating dangerous viruses for use as vaccines by desiccation was subsequently extended with chemical inactivation and repeated passages through animals or cell cultures. Treatment to kill (inactivate) the viruses while maintaining their ability to elicit protective immune responses became another approach to safer vaccines. One of the most successful is the Salk vaccine that used formaldehyde to inactivate the potentially deadly polio virus. Pasteur was of course one of the giants in the development of safe vaccines, some of which we still use today.8
The first insight into vaccine development arose from the observation that those infected were usually resistant to further infection. That must have been the rationale behind the work of the early Chinese inoculators, as well as Pasteur and Jenner. The challenge was to induce a protective immune response without the disabling effects of the diseases they were trying to guard against. Several of the COVID-19 vaccines developed so far, including the Pfizer-BioNTech and the Moderna vaccines, are highly effective against the original virus and the Delta variant that have caused over 5 million deaths so far, but early epidemiological data and molecular modelling suggest that Omicron may be more likely to show vaccine escape. How much of a threat this represents in terms of serious disease is still uncertain but as the numbers of those infected with Omicron increases, there is tentative evidence that the variant is less severe9 and that some of the existing vaccines remain effective, albeit at a lower level.10 Severity is defined at the population level, that is as the proportion of those infected ending up in hospital or dead, rather than as the distress caused at the individual infected person level. Even in southern Africa, where Omicron was first identified, only preliminary evidence is available.11 Definite answers to the questions that I was asked cannot be answered with certainty. However, complacency is to be avoided as the sparse data that is available does not allow us to infer with sufficient confidence that the Omicron variant is indeed any less likely to lead to hospitalizations than the Delta variant, particularly in the unvaccinated.4 Mathematical modelling and prediction models paint pictures that are only as good as the input data. In the COVID-19 world, the data are a rapidly moving target. Populations vary in age structure, vaccine coverage, particular vaccines used and extent of vaccine escape for each. What we see in South Africa is not necessarily predictive for the dynamics of the infection in other countries. Only a small increase in hospitalization is required to overwhelm healthcare systems already sitting on the razor blade of fatigue and winter woes. For this reason, governments worldwide are scrambling, if not for worst scenarios, at least for bad case scenarios.
It is unlikely that vaccine equity and universal vaccination will be achievable in the near term and much of the world will remain unvaccinated for at least another year. Moreover, there is a large residual pool of unvaccinated people and a time lag imposed by new vaccine development. There will therefore be many more infections, each with an opportunity to generate a new variant of concern through random mutations. If further data show that Omicron produces predominantly mild disease, then this is extremely good news. It would mean that the highly contagious variant would act as a natural vaccine, one that the ancient sages saw when they first came with the idea that deliberate infection with a milder form of contagion might prevent more severe disease. Before the age of modern vaccines, herd immunity against infectious diseases was achieved by this Darwinian evolution and natural infections.
3 WHAT IS NEW AND CONCLUSION
If Omicron turns out to be relatively mild in the previously vaccinated, and particularly in the unvaccinated, it may well be that when we look back at the history of the current pandemic, for all pandemics end, the variant would be seen as a contributor to its solution. Failing this, the outlook is bleak. In a continuing world of haves and have-nots, we hope that Omicron may once again be the instrument of the invisible hand of nature to mitigate the devastation of a dreaded infection; a hand that is more generous than the developed world in sharing its immunizations.
CONFLICT OF INTEREST
The author declare that there is no conflict of interest.
COVID-19 vaccines saved 20M lives in 1st year, scientists say – CTV News
Nearly 20 million lives were saved by COVID-19 vaccines during their first year, but even more deaths could have been prevented if international targets for the shots had been reached, researchers reported Thursday.
On Dec. 8, 2020, a retired shop clerk in England received the first shot in what would become a global vaccination campaign. Over the next 12 months, more than 4.3 billion people around the world lined up for the vaccines.
The effort, though marred by persisting inequities, prevented deaths on an unimaginable scale, said Oliver Watson of Imperial College London, who led the new modelling study.
“Catastrophic would be the first word that comes to mind,” Watson said of the outcome if vaccines hadn’t been available to fight the coronavirus. The findings “quantify just how much worse the pandemic could have been if we did not have these vaccines.”
The researchers used data from 185 countries to estimate that vaccines prevented 4.2 million COVID-19 deaths in India, 1.9 million in the United States, 1 million in Brazil, 631,000 in France and 507,000 in the United Kingdom.
An additional 600,000 deaths would have been prevented if the World Health Organization target of 40% vaccination coverage by the end of 2021 had been met, according to the study published Thursday in the journal Lancet Infectious Diseases.
The main finding — 19.8 million COVID-19 deaths were prevented — is based on estimates of how many more deaths than usual occurred during the time period. Using only reported COVID-19 deaths, the same model yielded 14.4 million deaths averted by vaccines.
The London scientists excluded China because of uncertainty around the pandemic’s effect on deaths there and its huge population.
The study has other limitations. The researchers did not include how the virus might have mutated differently in the absence of vaccines. And they did not factor in how lockdowns or mask wearing might have changed if vaccines weren’t available.
Another modelling group used a different approach to estimate that 16.3 million COVID-19 deaths were averted by vaccines. That work, by the Institute for Health Metrics and Evaluation in Seattle, has not been published.
In the real world, people wear masks more often when cases are surging, said the institute’s Ali Mokdad, and 2021’s Delta wave without vaccines would have prompted a major policy response.
“We may disagree on the number as scientists, but we all agree that COVID vaccines saved lots of lives,” Mokdad said.
The findings underscore both the achievements and the shortcomings of the vaccination campaign, said Adam Finn of Bristol Medical School in England, who like Mokdad was not involved in the study.
“Although we did pretty well this time — we saved millions and millions of lives — we could have done better and we should do better in the future,” Finn said.
Funding came from several groups including the WHO; the U.K. Medical Research Council; Gavi, the Vaccine Alliance; and the Bill and Melinda Gates Foundation.
AP health and science reporter Havovi Todd contributed
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content
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ACIP Backs Moderna's COVID Shot for Kids 6-17 Years – Medpage Today
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on Thursday to recommend that children ages 6-17 years receive Moderna’s COVID-19 vaccine.
With a 15-0 vote, ACIP endorsed a two-dose primary series of the mRNA vaccine for kids ages 6-11 years (50 mcg per dose) and adolescents ages 12-17 (100 mcg per dose). The recommendation now awaits approval from CDC Director Rochelle Walensky, MD, MPH.
The recommendation was largely expected, and followed FDA’s emergency use authorization last week. Until then, only Pfizer/BioNTech’s mRNA vaccine had been authorized and recommended for these age groups.
At Thursday’s meeting, ACIP members considered safety and efficacy data on Moderna’s vaccine, which was primarily studied during periods where the ancestral SARS-CoV-2 and Delta strains were predominant, in teens and the younger kids, respectively. In both groups, the vaccine was effective against severe disease and hospitalization.
“We know that the benefits outweigh the risks for mRNA COVID-19 vaccine in all ages,” said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, during the meeting. “Receipt of this primary series continues to be the safest way to prevent serious COVID-19.”
Oliver emphasized that serious outcomes with COVID-19 do not spare kids. The Omicron wave was accompanied by a surge in hospitalizations among children, and she pointed to 189 COVID-related deaths in kids 5-11 years and 443 in kids 12-17 throughout the course of the pandemic.
Several ACIP members raised questions about the intervals between the first and second dose of the Moderna vaccine, as such an approach may reduce the risk of myocarditis associated with the vaccine. Some evidence suggests the Moderna vaccine carries a higher risk of myocarditis or pericarditis than Pfizer’s vaccine, though CDC experts cautioned that these findings are not consistent in all U.S. monitoring systems.
Among close to 55 million doses of Pfizer’s vaccine administered to individuals ages 5-17 years, the rare adverse event has been observed in at least 635 children, according to the CDC. Risk is typically higher among children ages 12-17, in boys, and after the second dose. Among kids age 5-11, there were no signals detected.
In a presentation on clinical considerations, Elisha Hall, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, said that although the current recommendation is for a 4-week gap between the first and second doses, the CDC will likely be recommending an 8-week interval for adolescent males. (The CDC also recommends shorter dose intervals for children who are immunocompromised.)
Some of the ACIP members expressed confusion about the product labels on Moderna’s vaccines in each age group. The product authorized for kids 6-11 will have the same color cap as the vaccine for children ages 6 months to 5 years, but a different color border to distinguish the higher concentration. For the product authorized for kids ages 12-17, it will have the same label as the adult vaccine, as it is the same dose.
“I am … concerned about vaccine administration errors,” said Matthew Daley, MD, chair of ACIP’s working group. Others echoed concerns about administration blunders, encouraging more resources for providers and further clarification on labeling from the manufacturer.
Safety and efficacy data for Moderna’s vaccine in this younger population came from two ongoing phase II/III clinical trials (study mRNA-1273-P203 for adolescents ages 12-17 and study mRNA-1273-P204 for kids ages 6-11 years). The studies included nearly 8,000 kids in total.
Among participants ages 12-17, vaccine efficacy was 93.3% (95% CI 47.9-99.9) during a time when the ancestral and Alpha strains were predominant. Among the younger group, vaccine efficacy was 76.8% (95% CI -37.3 to 96.6) during a period when Delta was most prevalent.
The committee agreed on the data that COVID-19 vaccines protect children against severe disease. Many children in this age group, however, remain unvaccinated. Approximately 30% of teens and 65% of younger kids have yet to receive a vaccine, according to Oliver.
“We can predict with future COVID-19 surges, the unvaccinated will continue to bear the burden of disease,” she said.
COVID Rates Dropping; Vaccination Campaign Continues – ckdr.net
Health officials in Canada are warning of a seventh wave of COVID-19 this fall, with a possible new variant.
Dr. Kit Young Hoon is the Medical Officer of Health for the Northwestern Health Unit and stresses they will be ready.
“Although the timing of an increase in COVID-19 specifically is difficult to predict, the Northwestern Health Unit will be prepared to offer large-scale COVID-19 vaccinations in the fall to protect our communities most vulnerable.”
She notes the vaccine remains the best way to stay protected and vaccines continue to be offered for those eligible.
The Health Unit is reporting 132 COVID cases confirmed through PCR testing.
One hundred of them are in communities under the jurisdiction of the Sioux Lookout First Nations Health Authority.
Medical Officer of Health Dr. Kit Young Hoon says numbers are lower elsewhere.
“Overall, there’s been a steady decrease in hospitalizations due to COVID-19 locally. Case numbers in most health hubs are low, as are our institutional outbreak numbers”.
The positivity rate is sitting at 11.2%.
Case count (Health Hubs):
-Sioux Lookout (on reserve): 100
-Sioux Lookout: (off reserve): 5
-Red Lake: 3
-Fort Frances: 3
There are 3 institutional COVID outbreaks in the region.
That includes one at the Pinecrest home for the aged in Kenora.
Recent testing showed 25 residents testing positive for the virus.
Day and overnight absences have been placed on hold for the time being, but one essential caregiver is allowed for each resident.
Meantime, the Northwestern Health Health Unit says it’s important to continue to get booster doses for COVID-19 vaccinations.
Dr. Kit Young Hoon says there is evidence that the first or second dose starts to drop.
“The vaccine protection does wane somewhere around the six month mark, maybe a little bit earlier or a little bit later, depending on the individual,” says Dr. Young Hoon.
“So its important to have some sense what’s going on, with respect to vaccination policy, and know when you might be eligible in the future for your next dose.”
She adds vaccination criteria hasn’t changed that much over the past few months.
“If its been more than three month since you had COVID then you should be looking to book an appointment for your booster dose. There is added benefit from and protection from a booster dose so you have significantly reduced risk of severe illness and decreased risk from being infected.”
Dr. Young Hoon expects fourth dose eligibility will decrease from 60 years of age and older over the next few months, and the vaccine for kids under the age of five should be available later this summer.
For information on vaccinations, visit Northwestern Health Unit
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