COVID-19 is back. Again.
With masks coming off and highly transmissible subvariants of omicron circulating, people whove made it through the pandemic without getting SARS-CoV-2 are suddenly getting it.
People whove had it already are getting it again.
Its Oregons seventh surge.
Volunteer Jim Jackson of Portland cleans tables on May 2, 2022, as Blanchet House reopened for indoor dining following more than two years of closure due to the pandemic.
Kristyna Wentz-Graff / OPB
Its unfolding in a radically changed world, where most of our immune systems have some antibodies, from vaccines or previous infection, to deploy against the virus.
Thats curbing the virus terrors, if not its spread.
At the peak of the delta wave last summer, there were 197 COVID-19 patients on life support in Oregon. Last week, there were fewer than 10.
Prescott Principal Nichole Watson reminds students to keep their mask on their nose as she greets students in line for lunch at Prescott Elementary in Portland, Feb. 8, 2022.
Kristyna Wentz-Graff / OPB
OPB took its questions about the current wave and what it says about the long-term trajectory of the pandemic to Bill Messer, an expert in viral evolution and a clinician who cares for COVID-19 patients at OHSU.
Here are his observations about what COVID-19 is doing now, and where the pandemic is headed.
The number of reported cases is way up, close to the peak during the delta wave last summer.
But the number of deaths and hospitalizations remains comparatively low.
And that makes sense. There are more cases in people with some degree of protection from vaccines or previous infection, and the omicron variant is less virulent than delta.
It may be that it becomes a seasonal respiratory virus but that it wont carry with it the same horrific, devastating impact on our health care infrastructure going forward that it did early in the pandemic, Messer said.
Were seeing more and more evidence to suggest that that is indeed a likely pattern.
Messer cautions, however, that its too soon to say for sure if the health effects of COVID will continue to lessen, and there are multiple evolutionary paths the virus can take from here.
We may be approaching the limit of how much more contagious the coronavirus can get.
One of the major ways variants gain an evolutionary advantage is if they have mutations that make them more transmissible.
Each dominant variant of the COVID-19 virus has been more transmissible than the one it replaced.
You can see that looking at how the virus reproduction number, R0, has changed. The number measures how many new people each person with the virus infects, absent interventions like masking or vaccines.
The ancestral strain of SARS-CoV-2 had an R0 of between 2 and 3. That R0 increased to around 6 for the delta variant. The R0 is around 12 for the omicron subvariants circulating now.
That makes the novel coronavirus already one of the most contagious viruses ever, on par with chicken pox, but not quite as contagious as the measles.
Messer suspects SARS-CoV-2 is reaching the limit of how much more contagious it can get.
The number of new cases that arise from a single case cannot continue to rise infinitely, he said. Its going to plateau somewhere.
That hard limit is due to physical realities, like how many people we can come into contact with while infectious, or how much we can sneeze.
Theres always room for incremental increases, but Messer is not expecting another huge leap in contagiousness.
One of the most intriguing aspects of the omicron subvariants is their capacity for immune evasion: the ability to reinfect people whove been infected with other COVID-19 variants and to cause breakthrough infections in vaccinated people.
There are likely a couple of reasons for this. First, research has shown that our immunity to COVID-19 wanes relatively quickly.
And evolution favors variants with mutations that help the virus evade our immune response.
Messer believes that going forward, we will likely see new variants that are better at reinfecting us.
Interestingly, this ability to cause repeat infections relatively frequently is a trait SARS-CoV-2 appears to share with other important coronaviruses: the four viruses that cause the common cold.
Messer said researchers recently learned that People are reinfected with cold viruses about once every 30 months, with evidence that some people can experience multiple infections from the same cold virus within six months or less.
Some of those repeat infections may be too mild to cause symptoms.
Messer believes its reasonable to think a similar pattern may emerge with COVID-19, where people get short-term immunity from infection or vaccination, but a vaccine that confers five-year immunity is off the table.
It looks like its going to be shorter than that, and it is going to be seasonal and cyclical, he said.
While vaccination and prior infection wont completely protect you from COVID-19, you do retain some antibodies that can mount a response to future infections.
Even waning antibodies offer decent protection against the most severe outcomes, like hospitalization and death.
But long-term antibody protection may wane over time, and reinfections are still causing relatively serious symptoms for many people, Messer said.
In terms of its ability to disrupt our lives and cause pain, theres still a huge difference between catching a seasonal COVID-19 variant once a year and a seasonal cold.
Messer said its hard to know why. It could be that SARS-CoV-2 is just a little different, and nastier, than the common cold coronaviruses.
Or, it could appear nastier because its still very early days in this pandemic, from an evolutionary point of view.
We dont know how long the four viruses that cause the common cold have been circulating, or if they also appeared more virulent at first.
There is one intriguing set of clues, however.
Some scientists believe they have pinpointed how and when one of the four common cold viruses, human coronavirus OC43, was introduced.
If theyre right, its a scenario with many echoes of the current pandemic.
The researchers have hypothesized that OC43 leaped from cattle to humans about 130 years ago.
It may have been the cause of a well-documented global respiratory pandemic that killed more than 1 million people from 1889 to 1891.
If that hypothesis is correct, Messer said, it strengthens the argument that over some period of years and many repeat infections, SARS-CoV-2 will become a less terrible virus.
The counterargument is the virus is really agnostic about how virulent it is, it really just wants to be transmissible and survive from host to host, he said.
The vaccine most of us have received was formulated to protect against the first COVID-19 virus we encountered. While its still providing protection against the worst outcomes of infection, its not a great fit for the omicron subvariants.
Pfizer and Moderna are developing an omicron variant vaccine, but those efforts are moving slowly.
Messer said designing antigens for an omicron variant vaccine isnt that hard.
The bigger problem is whether a new vaccine will earn or lose money for its maker.
COVID-19 vaccine preparation at a drive-thru vaccination clinic at Portland International Airport, April 9, 2021. The clinic is a joint operation hosted by Oregon Health & Science University, the Port of Portland and the American Red Cross.
Kristyna Wentz-Graff/ OPB
Vaccine makers need to see that the public is willing to get an updated version of the COVID-19 vaccine to make it worth investing in it, Messer said.
That may depend in part on how mild, or severe, breakthrough infections are for people whove already been vaccinated.
In addition, vaccine makers will need to bet that the omicron variants will still be the dominant branch of the COVID-19 family tree when a vaccine is ready to get into arms. The virus rapid evolution makes that uncertain.
I dont see the clear path forward to the investment in rolling out the next variant vaccine paying off. Thats a cynical way of looking at it, Messer said.
Messer has yet to catch COVID-19 himself. Part luck, part care, part the privilege of working in a place with masking and good hand hygiene.
He said people like him who are vaccinated but havent been infected are likely pretty susceptible to getting COVID-19.
The data is clear that antibodies you get from vaccination wane relatively quickly. And that is a reason, according to Messer, to follow his advice.
If you havent gotten a booster, he said, do it now.
The overall pace of COVID-19 activity in the United States has showed some signs of leveling off, with the disease burden indicating a shift from east to west.
Meanwhile, advisers to the US Food and Drug Administration (FDA) will meet tomorrow to discuss emergency use of the Novavax COVID-19 vaccine.
The 7-day average for new daily COVID-19 cases is 105,576, with 269 daily deaths, according to the Washington Post tracker. Over the past week, cases dropped 1% after rising slowly since about the middle of April. Hospitalizations over the past week rose 8%, while deaths dropped 27%.
The nation faces an uncertain summer, with the more transmissible BA.2.12.1 Omicron subvariantfirst seen in New Yorkbecoming the dominant strain over the past 2 weeks. Officials are closely watching two other more transmissible subvariants, BA.4 and BA.5, that recently triggered a modest wave in South Africa and have been linked to a fresh rise in cases in Portugal.
In the United States, the increase in COVID-19 cases appears to be slowing in the Northeast, according to the New York Times. Levels appear to be rising westward, however, according to a Wall Street Journal analysis of CDC data. It said the West recently passed the Northeast as the area with the highest rate of known cases per 100,000 people.
Meanwhile, the nation's overall COVID vaccine uptake has been roughly level since the middle of April, with 66.7% of Americans fully vaccinated. Less than half (46.9%) have received their first booster dose. As vaccination stalls, the US discarded 82.1 million COVID-19 doses from December 2020 through the middle of May, according to CDC data shared with NBC News. That amount makes up just over 11% of doses distributed by the federal government.
In other vaccine developments, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBAC) tomorrow will consider an emergency use authorization request for the Novavax COVID-19 vaccine, a recombinant nanoparticle protein-based product that contains an adjuvant and is given in two doses 3 weeks apart.
Though the vaccine is a late entrant into the immunization landscape, health officials have hoped that the new offering could raise vaccine uptake in Americans, given that it is made using a more traditional production platform.
A review by FDA staff ahead of tomorrow VRBPAC meeting said it will likely provide meaningful protection against the Omicron variant, but they raised concerns about the potential for rare cardiac conditions after vaccination, similar to associations found earlier with mRNA vaccines.
Though global cases have resumed a slow decline, some countries are seeing rises as they grapple different situations regarding more transmissible subvariants.
(Credit: Unsplash)
This article was exclusively written forThe European Stingby Mr. Olivier Sibomana, an enthusiastic and highly committed medical student at University of Rwanda (UR), college of medicine and health sciences, department of general medicine and surgery. He is affiliated with the International Federation of Medical Students Associations (IFMSA), cordial partner of The Sting. The opinions expressed in this piece belong strictly to the writers and do not necessarily reflect IFMSAs view on the topic, nor The European Stings one.
In December 2019, a new coronavirus was found in Wuhan city, China. Coronavirus Study Group of the International Committee on Taxonomy of Virus named the new virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and later, a disease caused by the virus was named coronavirus disease 2019 (COVID-19) by World Health Organization (WHO)[1].
COVID-19 spread in almost all countries of the world causing a large number of deaths. Strict measures such as intermittent lockdowns and social distancing have been taken and applied. Great effort and a huge amount of money was invested to develop a vaccine against COVID-19 [2] as vaccines are among the safest and most effective tools in infectious diseases control [3], and it has been found that few medical interventions compete with vaccines in infectious diseases control [4].
In the early time of the pandemic, a vaccine was just a hope, but after its availability, many people showed hesitancy about it [5]. Vaccine hesitancy is a global health issue that WHO declared as top 10 global health threats [6]. WHO Strategic Advisory Group of Experts (SAGE) defines vaccine hesitancy as a delay in acceptance or refusal of vaccination despite the availability of vaccination services [7].
In this article, I will explain the main reasons behind COVID-19 vaccine hesitancy; the low rate of COVID-19 vaccine acceptance, and discuss some evidence-based strategies that can be used to reduce COVID-19 vaccine hesitancy and increase herd vaccination in the population.
Determinants of vaccine hesitancy have been recently explained by using the 3C model: confidence, competence, and convenience [8]. Confidence covers all issues on the safety of the vaccine, competence focuses on healthcare systems that deliver vaccines and competence of healthcare workers, and convenience measures the availability and affordability of vaccination services.
Mistrust of health authorities and doubt about the safety and efficacy of vaccines are the main reported reasons behind COVID-19 vaccine hesitancy [1]. A recent study in France showed that people were hesitant to COVID-19 vaccine because the vaccines were manufactured in an emergency and hence their safety is doubtful [9].
We must not forget political factors while explaining the reasons behind COVID-19 vaccine hesitancy. Many people started thinking about this, and their fear and mistrust of the government rose after many scientists questioned the approval of COVID-19 vaccines for emergency use by the US Food and Drug Authority (FDA) [10]. Rumors and misperceptions which were distributed on social media greatly increased this fear and mistrust of the government. One of these rumors said that the COVID-19 vaccine was manufactured and is going to be injected into people to track personal data [5]. This indicates the negative effects of social media and its role in increasing hesitancy on COVID-19 vaccines.
Although there is an increase in awareness of the importance of vaccines, vaccine hesitancy is increasing due to changes in scientific, social, cultural, spiritual, and media environments [11]. Social norms have been found to at a high-level influence COVID-19 vaccine acceptance. Due to their culture and social norms, many people refuse to be vaccinated and are susceptible to the infection. Religiosity also is among the reasons for COVID-19 vaccine hesitancy [12]. Some religions do not allow their believers to be vaccinated.
This highlights the negative role played by culture, social norms, and religiosity in vaccine hesitancy.
Other reasons behind COVID-19 vaccine hesitancy include the low level of education and experience with past vaccination [7][13]. Uneducated people and those with a low level of education are observed to show a high level of vaccine hesitancy compared to highly-educated people. A variety of people had a bad experience with past vaccination while being vaccinated against other diseases besides COVID-19. Some people got such experience with the first dose of the COVID-19 vaccine. This caused them to refuse the further doses of the vaccine and full immunization was not achieved.
After understanding the main causes of COVID-19 vaccine hesitancy and its negative effects in a battle for eradication of the disease, it is understandable that effective strategies must be used to reduce the low rate of COVID-19 vaccine acceptance. The most effective strategies that can be used include education, public campaigns on awareness of the importance of the vaccine, and the use of social media to provide truthful information about the disease and the vaccines instead of rumors that cause fear and mistrust in the population.
Clinicians and health workers, in general, are thought to be the source of trusted health information. Therefore, the recommendation of the COVID-19 vaccine by the clinicians was reported to increase the rate of vaccine acceptance. In a recent study, many people declared that they would accept the vaccine if recommended by their clinicians [10]. These recommendations may build confidence in people and make them believe in the safety and efficacy of the vaccine.
Messaging systems also can be used as a strategy to reduce COVI-19 vaccine hesitancy and increase vaccine acceptance. Unified messages from medical providers [14] to individuals, especially parents, on the benefits of vaccines and the time of taking them for themselves and their children [15] can play a great role in making people understand how dreadful is COVID-19 and how important is accepting vaccines to build strong immunity against the disease.
Vaccination campaigns targeting precarious populations [16], and the public, in general, can help in increasing vaccine uptake and reducing hesitancy on the vaccine. Campaigns aiming at clarifying the social benefits of vaccination are believed to give observable good outcomes in increasing the rate of COVID-19 vaccine acceptance.
Even though social media was reported to be the source of rumors that make people fearful of vaccines and become hesitant, it can also be used to contradict these rumors and give accurate information about vaccines, especially the COVID-19 vaccine to the public. On the internet, more than 48,000 contents related to vaccines are produced every month [17]. This explains the impact of social media on increasing COVID-19 vaccine acceptance. Nowadays, many people are getting interested in getting information from the internet. Understandably, information including the importance of vaccines must be published at a high rate to satisfy the curiosity of many people who are still in a dilemma on whether to take the vaccine or not.
In conclusion, COVID-19 vaccine hesitancy is a great hindrance in implementing measures to fight against COVID-19. Lack of trust in health professionals and the government and doubt about the safety of vaccines have been the main causes of hesitancy on COVID-19 vaccines. Further research is recommended to know the real burden of vaccine hesitancy worldwide. Strategies such as education, campaigns, and publishing more information on vaccines have been found to play a great role in reducing vaccine hesitancy and increasing the rate of vaccine uptake. Deep surveys and research must be done to develop other applicable strategies that can be used to reduce COVID-19 vaccine hesitancy.
References
[1] G. Troiano and A. Nardi, Vaccine hesitancy in the era of COVID-19, Public Health, vol. 194. Elsevier B.V., pp. 245251, May 01, 2021. doi: 10.1016/j.puhe.2021.02.025.
[2] A. A. Dror et al., Vaccine hesitancy: the next challenge in the fight against COVID-19, European Journal of Epidemiology, vol. 35, no. 8, pp. 775779, Aug. 2020, doi: 10.1007/s10654-020-00671-y.
[3] B. Hickler, S. Guirguis, and R. Obregon, Vaccine Special Issue on Vaccine Hesitancy, Vaccine, vol. 33, no. 34. Elsevier Ltd, pp. 41554156, Aug. 14, 2015. doi: 10.1016/j.vaccine.2015.04.034.
[4] A. Schuchat, Human Vaccines and Their Importance to Public Health, Procedia in Vaccinology, vol. 5, pp. 120126, 2011, doi: 10.1016/j.provac.2011.10.008.
[5] S. A. Nossier, Vaccine hesitancy: the greatest threat to COVID-19 vaccination programs, Journal of the Egyptian Public Health Association, vol. 96, no. 1, Dec. 2021, doi: 10.1186/s42506-021-00081-2.
[6] C. Reno et al., Enhancing covid-19 vaccines acceptance: results from a survey on vaccine hesitancy in northern Italy, Vaccines (Basel), vol. 9, no. 4, Apr. 2021, doi: 10.3390/vaccines9040378.
[7] S. Lane, N. E. MacDonald, M. Marti, and L. Dumolard, Vaccine hesitancy around the globe: Analysis of three years of WHO/UNICEF Joint Reporting Form data-20152017, Vaccine, vol. 36, no. 26, pp. 38613867, Jun. 2018, doi: 10.1016/j.vaccine.2018.03.063.
[8] E. O. Oduwole, E. D. Pienaar, H. Mahomed, and C. S. Wiysonge, Current tools available for investigating vaccine hesitancy: A scoping review protocol, BMJ Open, vol. 9, no. 12. BMJ Publishing Group, Dec. 11, 2019. doi: 10.1136/bmjopen-2019-033245.
[9] V. C. Lucia, A. Kelekar, and N. M. Afonso, COVID-19 vaccine hesitancy among medical students, Journal of Public Health (United Kingdom), vol. 43, no. 3, pp. 445449, Sep. 2021, doi: 10.1093/pubmed/fdaa230.
[10] L. J. Finney Rutten et al., Evidence-Based Strategies for Clinical Organizations to Address COVID-19 Vaccine Hesitancy, Mayo Clinic Proceedings, vol. 96, no. 3. Elsevier Ltd, pp. 699707, Mar. 01, 2021. doi: 10.1016/j.mayocp.2020.12.024.
[11] D. Kumar, R. Chandra, M. Mathur, S. Samdariya, and N. Kapoor, Vaccine hesitancy: Understanding better to address better, Israel Journal of Health Policy Research, vol. 5, no. 1, Feb. 2016, doi: 10.1186/s13584-016-0062-y.
[12] M. Sallam, Covid-19 vaccine hesitancy worldwide: A concise systematic review of vaccine acceptance rates, Vaccines, vol. 9, no. 2. MDPI AG, pp. 115, Feb. 01, 2021. doi: 10.3390/vaccines9020160.
[13] C. Jarrett et al., Strategies for addressing vaccine hesitancy A systematic review, Vaccine, vol. 33, no. 34. Elsevier Ltd, pp. 41804190, Aug. 14, 2015. doi: 10.1016/j.vaccine.2015.04.040.
[14] D. Callender, Vaccine hesitancy: More than a movement, Human Vaccines and Immunotherapeutics, vol. 12, no. 9. Taylor and Francis Inc., pp. 24642468, Sep. 01, 2016. doi: 10.1080/21645515.2016.1178434.
[15] M. Siddiqui, D. A. Salmon, and S. B. Omer, Epidemiology of vaccine hesitancy in the United States, Human Vaccines and Immunotherapeutics, vol. 9, no. 12. pp. 26432648, Dec. 2013. doi: 10.4161/hv.27243.
[16] C. Fokoun, Strategies implemented to address vaccine hesitancy in France: A review article, Human Vaccines and Immunotherapeutics, vol. 14, no. 7. Taylor and Francis Inc., pp. 15801590, Jul. 03, 2018. doi: 10.1080/21645515.2018.1458807.
[17] N. E. MacDonald et al., Vaccine hesitancy: Definition, scope and determinants, Vaccine, vol. 33, no. 34, pp. 41614164, Aug. 2015, doi: 10.1016/j.vaccine.2015.04.036.
About the author
Olivier SIBOMANA is an enthusiastic and highly committed medical student at University of Rwanda (UR), college of medicine and health sciences, department of general medicine and surgery. He is a Rwandan active member of Medical Students Association of Rwanda (MEDSAR), serving in the standing committee on public health (SCOPH). Olivier is interested in medicine and global health, makes advocacy on public health issues, and does research that focus on infectious and tropical diseases.
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The UT-Austin chemistry lab's essential work has been used in various coronavirus vaccines, and even in vaccines meant to combat respiratory syncytial virus
AUSTIN, Texas Since COVID-19 first started taking the world by hostage in late 2019, scientists across the globe have been working nonstop to unlock the virus' mysteries and to provide a blueprint for battling the contagious disease.
And some of the best work in the world on this front has been taking place inside a lab at the University of Texas at Austin.
"I wanted to go into science -- and specifically this field -- to try to contribute to vaccine development, to hopefully make or contribute to a vaccine that would one day be used," said Dr. Jason McLellan on this week's episode of Yall-itics. "Yeah, to have our technology incorporated into all these different vaccines -- its more than five vaccines, its a career high -- its really exciting."
Dr. McLellan holds the Robert A. Welch Chair in chemistry at UT-Austin, where he also serves as a professor of molecular biology.
Now, the technology he and his team have developed is being used both in vaccines against RSV (respiratory syncytial virus), which is especially dangerous to children and seniors, and in the leading vaccines against COVID-19.
If you thought the development of a COVID-19 vaccine was fast, Dr. McLellan says that, because of the work theyve done, theyll be able to do it much quicker in the future -- even through means like delivering vaccines through a patch.
"The goals now are to try to go from genome sequence of a virus to manufactured vaccine in 100 days," he said. "It's about three months rather than 10. So, maybe in the future, you have a coronavirus emerge in Southeast Asia, you need a couple of months of masking and social distancing, and then everybody can get the vaccine that's tailored specifically for that virus."
Even though he works with some dangerous material inside his lab, Dr. McLellan told the Jasons thats not even what truly scares him.
"What keeps me up at night mostly is the anti-vax and the misinformation campaign," he said. "That's actually most scary and deleterious to human health. If we had a similar sentiment and vaccine skepticism 50 years ago, we might not have eradicated smallpox, or polio. So, it's really unnerving."
Interestingly enough, Dr. McLellan actually put in a grant to the National Institutes of Health in 2017 in an effort to develop a universal coronavirus vaccine.
Think about that for a second: That would have been three years before the pandemic even started.
But McLellan now smiles when talking about how his own words doomed the effort.
"That did not receive very good scores," he said. "And the reviewer comments? 'You indicated that this work was not particularly impactful, [that] coronavirus outbreaks are regionally contained to where they first emerged.' So, that was fun."
McLellan even tweeted a screen shot of that rejection. No surprise, then: It since has become one his most liked tweets.
Be sure to listen to the rest of this fascinating conversation with one of the worlds most important scientists in this episode of Yall-itics.
The UT-Austin chemistry lab's essential work has been used in various coronavirus vaccines, and even in vaccines meant to combat respiratory syncytial virus
AUSTIN, Texas Since COVID-19 first started taking the world by hostage in late 2019, scientists across the globe have been working nonstop to unlock the virus' mysteries and to provide a blueprint for battling the contagious disease.
And some of the best work in the world on this front has been taking place inside a lab at the University of Texas at Austin.
"I wanted to go into science -- and specifically this field -- to try to contribute to vaccine development, to hopefully make or contribute to a vaccine that would one day be used," said Dr. Jason McLellan on this week's episode of Yall-itics. "Yeah, to have our technology incorporated into all these different vaccines -- its more than five vaccines, its a career high -- its really exciting."
Dr. McLellan holds the Robert A. Welch Chair in chemistry at UT-Austin, where he also serves as a professor of molecular biology.
Now, the technology he and his team have developed is being used both in vaccines against RSV (respiratory syncytial virus), which is especially dangerous to children and seniors, and in the leading vaccines against COVID-19.
If you thought the development of a COVID-19 vaccine was fast, Dr. McLellan says that, because of the work theyve done, theyll be able to do it much quicker in the future -- even through means like delivering vaccines through a patch.
"The goals now are to try to go from genome sequence of a virus to manufactured vaccine in 100 days," he said. "It's about three months rather than 10. So, maybe in the future, you have a coronavirus emerge in Southeast Asia, you need a couple of months of masking and social distancing, and then everybody can get the vaccine that's tailored specifically for that virus."
Even though he works with some dangerous material inside his lab, Dr. McLellan told the Jasons thats not even what truly scares him.
"What keeps me up at night mostly is the anti-vax and the misinformation campaign," he said. "That's actually most scary and deleterious to human health. If we had a similar sentiment and vaccine skepticism 50 years ago, we might not have eradicated smallpox, or polio. So, it's really unnerving."
Interestingly enough, Dr. McLellan actually put in a grant to the National Institutes of Health in 2017 in an effort to develop a universal coronavirus vaccine.
Think about that for a second: That would have been three years before the pandemic even started.
But McLellan now smiles when talking about how his own words doomed the effort.
"That did not receive very good scores," he said. "And the reviewer comments? 'You indicated that this work was not particularly impactful, [that] coronavirus outbreaks are regionally contained to where they first emerged.' So, that was fun."
McLellan even tweeted a screen shot of that rejection. No surprise, then: It since has become one his most liked tweets.
Be sure to listen to the rest of this fascinating conversation with one of the worlds most important scientists in this episode of Yall-itics.
TUCSON, Ariz., June 06, 2022 (GLOBE NEWSWIRE) -- Given the concerns about the safety of mandated COVID-19 vaccines, one would expect a large and growing number of reports of autopsies of persons who died soon after receiving an mRNA vaccine. However, counterintuitively, despite this obvious need, available data are very scarce, writes Jane Orient, M.D., in a guest editorial in the summer issue of the Journal of American Physicians and Surgeons.
A diligent search in reputable medical databases for any paper containing autopsy data related to COVID vaccines turned up only about 15 unimpressive studies, Dr. Orient writes. Surprisingly, most of those publications are not autopsy-dedicated papers, but morbidity-and-mortality reports including some postmortem data.
The World Health Organization (WHO) recognizes the need for study of adverse events following immunization (AEFIs) and points out that pathological studies including autopsies are required to establish evidence of a causal relationship between a vaccine and AEFI safety signals, Dr. Orient writes.
The vacuum in the official medical literature is being filled by information of variable quality presented on alternative platforms, she notes. From the plethora of dissenting reports presented on such platforms, she selected the widely disseminated German Pathology Conferences for analysis.
The standard pathology slides were mostly interpreted correctly, based on comparisons with similar findings in the standard medical literature, she found. The unorthodox content, an attempt at a forensic analysis of vaccine content, mostly using dark-field microscopy, was, however, problematic. The unusual foreign bodies might have been artifacts, such as cholesterol clefts, which are of no significance except for being mistaken for foreign bodies.
Dr. Orient concludes that the pathology conferences do not prove the harm of vaccines but are nonetheless a useful challenge to official experts.
The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS), a national organization representing physicians in all specialties since 1943.
The Colorado Department of Public Health and Environment Mobile Vaccine Clinic will be in the Conference Room offering walk up COVID-19 vaccines and boosters to all eligible, including those ages 5-11. Pfizer, Moderna and Johnson & Johnson will be available.
In partnership with Governor Polis Vaccines for All efforts.
The Association Between COVID-19 Mortality And The County-Level Partisan Divide In The United States healthaffairs.org
After more than a year with two types of COVID-19 vaccines in use in the United States, another will be up for consideration by the U.S. Food and Drug Administration this week.The FDA's vaccine advisers are set to meet Tuesday to consider Novavax's coronavirus vaccine for the nation.Based on data included in an agency briefing document posted Friday, an FDA review found that the vaccine's efficacy was 90.4% overall against mild, moderate or severe COVID-19 for a period of 2 months after completing the two-dose primary series. The document notes that, in a primary analysis, the vaccine efficacy fell to 78.6% among adults 65 and older.Those efficacy numbers were collected before the emergence of the omicron coronavirus variant. It remains unclear how long protection lasts or how well the vaccine will protect against omicron.In an announcement published in December, the company reported that the vaccine had "broad cross-reactivity against omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months."Novavax's vaccine, called NVX-CoV2373, is given as two doses three weeks apart for the primary vaccination series.Although most adverse reactions to the vaccine were mild to moderate and lasted just a few days, the FDA did describe rare events of myocarditis and pericarditis -- inflammation of the heart muscle and inflammation of tissue surrounding the heart -- associated with the vaccine."Multiple events of myocarditis/ pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373," the FDA's briefing document says.The document describes six cases that happened after vaccination with Novavax. Five were among males ranging in age from 16 to 67. Of the six cases, five were hospitalized but have since recovered.An increased risk of myocarditis and pericarditis has been identified among people who received the mRNA Pfizer/BioNTech and Moderna COVID-19 vaccines now used in the United States.In a statement Friday, Novavax addressed the heart inflammation concerns specifically: "We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk. Myocarditis is most often caused by nonspecific viral infections." It said that the rate of myocarditis in vaccinated participants was similar to the placebo group.The company added, "we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis."The most common adverse reactions to the vaccine were pain at the injection site, fatigue, headache and muscle ache. Reactions were reported more commonly in younger participants in the vaccine's clinical trials.In its briefing document, the FDA summarized, "The known benefits among vaccine recipients 18 years of age and older relative to placebo are reductions in the risk of mild to severe COVID-19 occurring at least 7 days after the second primary series vaccination."In Tuesday's meeting, the FDA's vaccine advisory committee members will vote on the question: "Based on the totality of scientific evidence available, do the benefits of the Novavax COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in individuals 18 years of age and older?"'We believe our vaccine offers a differentiated option'In late January, Novavax announced that it had submitted a request for the FDA to authorize its coronavirus vaccine for emergency use in the United States.In November, Indonesia became the first country to grant emergency use authorization of Novavax's vaccine. It has since been authorized in the European Union, the United Kingdom, Canada, South Korea, Australia, India, the Philippines and New Zealand, among other countries.Even though most adults in the United States have been vaccinated against COVID-19, the head of the company has said that it sees Novavax's vaccine as a potential option for booster doses, regardless of which type of vaccine was given for a person's initial doses.Novavax's vaccine was developed as a protein subunit vaccine, a more traditional type of technology than the mRNA used for the Moderna and Pfizer vaccines. Other examples of subunit vaccines are the hepatitis B and pertussis vaccines."We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Novavax CEO Stanley Erck said in a statement in January.Novavax's protein-based coronavirus vaccine relies on something called recombinant nanoparticle technology and Novavax's adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies.Protein-based vaccines like Novavax's work by getting the body's immune system to recognize little modified pieces of the virus it's targeting. In Novavax's case, that means pieces of the coronavirus spike protein.When the genetic sequence for the virus that causes Covid-19 was published, scientists around the world quickly identified it as a coronavirus because of the "spike proteins" on its surface. These spikes form large protrusions, giving coronaviruses the appearance of wearing crowns, and "corona" is the Latin word for "crown."Novavax scientists identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells -- specifically, cells from the fall armyworm -- prompting them to produce the coronavirus spike protein.These virus-like nanoparticles were harvested to make Novavax's vaccine."The whole idea of the vaccine is to show the immune system something that looks, tastes and acts like a virus, with the exception that it doesn't make you sick. So we made the spike protein. We put it in a particle -- basically, like a soap bubble -- and it's the size of the virus," Dr. Gregory Glenn, president of research and development for Novavax, told CNN last year."It's not infectious. We never touch the coronavirus itself," Glenn added. "Then that is given to people, and they make an immune response that's very much focused just on the spike -- and I would say, the hallmark of our vaccine is, it gives a very strong immune response with very few side effects, and the dose is very small and the vaccine can be stored with normal refrigerated temperatures."Novavax starts Phase 3 trial of omicron-specific boosterAs Novavax seeks emergency use authorization of its NVX-CoV2373 vaccine, it also is studying a separate vaccine that specifically targets the omicron variant, called NVX-CoV2515. The company announced this week that it has started a Phase 3 trial of this vaccine, assessing its safety and efficacy as a booster shot."The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine," Novavax said in a news release.The trial will analyze the omicron-specific vaccine and a bivalent vaccine in more than 1,000 participants in Australia.Two doses of either the omicron-specific vaccine or the original NVX-CoV2373 vaccine will be given after three doses of either the Pfizer-BioNTech and/or Moderna vaccines that were received at least three months before participants joined the trial.Similarly, two doses of the omicron-specific vaccine or the original NVX-CoV2373 will be given after two doses of either mRNA vaccines received at least six months before joining the trial.Two doses of the bivalent vaccine will be administered in participants vaccinated with three doses of either mRNA vaccine at least three months before joining the trial.The trial will last about 10 months, and initial results are expected in the second half of this year.
After more than a year with two types of COVID-19 vaccines in use in the United States, another will be up for consideration by the U.S. Food and Drug Administration this week.
The FDA's vaccine advisers are set to meet Tuesday to consider Novavax's coronavirus vaccine for the nation.
Based on data included in an agency briefing document posted Friday, an FDA review found that the vaccine's efficacy was 90.4% overall against mild, moderate or severe COVID-19 for a period of 2 months after completing the two-dose primary series. The document notes that, in a primary analysis, the vaccine efficacy fell to 78.6% among adults 65 and older.
Those efficacy numbers were collected before the emergence of the omicron coronavirus variant. It remains unclear how long protection lasts or how well the vaccine will protect against omicron.
In an announcement published in December, the company reported that the vaccine had "broad cross-reactivity against omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months."
Novavax's vaccine, called NVX-CoV2373, is given as two doses three weeks apart for the primary vaccination series.
Although most adverse reactions to the vaccine were mild to moderate and lasted just a few days, the FDA did describe rare events of myocarditis and pericarditis -- inflammation of the heart muscle and inflammation of tissue surrounding the heart -- associated with the vaccine.
"Multiple events of myocarditis/ pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373," the FDA's briefing document says.
The document describes six cases that happened after vaccination with Novavax. Five were among males ranging in age from 16 to 67. Of the six cases, five were hospitalized but have since recovered.
An increased risk of myocarditis and pericarditis has been identified among people who received the mRNA Pfizer/BioNTech and Moderna COVID-19 vaccines now used in the United States.
In a statement Friday, Novavax addressed the heart inflammation concerns specifically: "We have learned that we can expect to see natural background events of myocarditis in any sufficiently large database, and that young males are at higher risk. Myocarditis is most often caused by nonspecific viral infections." It said that the rate of myocarditis in vaccinated participants was similar to the placebo group.
The company added, "we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis."
The most common adverse reactions to the vaccine were pain at the injection site, fatigue, headache and muscle ache. Reactions were reported more commonly in younger participants in the vaccine's clinical trials.
In its briefing document, the FDA summarized, "The known benefits among vaccine recipients 18 years of age and older relative to placebo are reductions in the risk of mild to severe COVID-19 occurring at least 7 days after the second primary series vaccination."
In Tuesday's meeting, the FDA's vaccine advisory committee members will vote on the question: "Based on the totality of scientific evidence available, do the benefits of the Novavax COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in individuals 18 years of age and older?"
In late January, Novavax announced that it had submitted a request for the FDA to authorize its coronavirus vaccine for emergency use in the United States.
In November, Indonesia became the first country to grant emergency use authorization of Novavax's vaccine. It has since been authorized in the European Union, the United Kingdom, Canada, South Korea, Australia, India, the Philippines and New Zealand, among other countries.
Even though most adults in the United States have been vaccinated against COVID-19, the head of the company has said that it sees Novavax's vaccine as a potential option for booster doses, regardless of which type of vaccine was given for a person's initial doses.
Novavax's vaccine was developed as a protein subunit vaccine, a more traditional type of technology than the mRNA used for the Moderna and Pfizer vaccines. Other examples of subunit vaccines are the hepatitis B and pertussis vaccines.
"We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Novavax CEO Stanley Erck said in a statement in January.
Novavax's protein-based coronavirus vaccine relies on something called recombinant nanoparticle technology and Novavax's adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies.
Protein-based vaccines like Novavax's work by getting the body's immune system to recognize little modified pieces of the virus it's targeting. In Novavax's case, that means pieces of the coronavirus spike protein.
When the genetic sequence for the virus that causes Covid-19 was published, scientists around the world quickly identified it as a coronavirus because of the "spike proteins" on its surface. These spikes form large protrusions, giving coronaviruses the appearance of wearing crowns, and "corona" is the Latin word for "crown."
Novavax scientists identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells -- specifically, cells from the fall armyworm -- prompting them to produce the coronavirus spike protein.
These virus-like nanoparticles were harvested to make Novavax's vaccine.
"The whole idea of the vaccine is to show the immune system something that looks, tastes and acts like a virus, with the exception that it doesn't make you sick. So we made the spike protein. We put it in a particle -- basically, like a soap bubble -- and it's the size of the virus," Dr. Gregory Glenn, president of research and development for Novavax, told CNN last year.
"It's not infectious. We never touch the coronavirus itself," Glenn added. "Then that is given to people, and they make an immune response that's very much focused just on the spike -- and I would say, the hallmark of our vaccine is, it gives a very strong immune response with very few side effects, and the dose is very small and the vaccine can be stored with normal refrigerated temperatures."
As Novavax seeks emergency use authorization of its NVX-CoV2373 vaccine, it also is studying a separate vaccine that specifically targets the omicron variant, called NVX-CoV2515. The company announced this week that it has started a Phase 3 trial of this vaccine, assessing its safety and efficacy as a booster shot.
"The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine," Novavax said in a news release.
The trial will analyze the omicron-specific vaccine and a bivalent vaccine in more than 1,000 participants in Australia.
Two doses of either the omicron-specific vaccine or the original NVX-CoV2373 vaccine will be given after three doses of either the Pfizer-BioNTech and/or Moderna vaccines that were received at least three months before participants joined the trial.
Similarly, two doses of the omicron-specific vaccine or the original NVX-CoV2373 will be given after two doses of either mRNA vaccines received at least six months before joining the trial.
Two doses of the bivalent vaccine will be administered in participants vaccinated with three doses of either mRNA vaccine at least three months before joining the trial.
The trial will last about 10 months, and initial results are expected in the second half of this year.
In a recent study review posted to the medRxiv* preprint server, researchers evaluated the economic and medical costs incurred due to the coronavirus disease 2019 (COVID-19) pandemic. They also assessed the cost-effectiveness of surveillance, response measures, and preparedness for COVID-19.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections have caused economic disruptions, loss of lives, and social disturbances with a profound impact on healthcare systems, societies, and the general population. Data on the economic impact of COVID-19 is indispensable for improving decision-making and allocating resources for enhanced preparation for COVID-19 and future pandemics.
Study: The cost of the COVID-19 pandemic vs the cost-effectiveness of mitigation strategies in the EU/UK/EEA and OECD countries: a systematic review. Image Credit:Corona Borealis Studio / Shutterstock
In the present systematic review, researchers assessed the economic burden of COVID-19 on healthcare systems, societies, the general population, and within-population subgroups in Europe, the United Kingdom, and member nations of the European environment agency (EEA) and the organization for economic cooperation and development (OECD).
Studies published in the EMBASE and Ovid Medline databases between January 1, 2020, and April 22, 2021, were selected to determine the costs incurred due to COVID-19 and the cost benefits of pharmaceutical and non-pharmaceutical interventions (NPIs). Public health preparedness measures or interventions were compared to cost of inaction/no intervention and cost of preparedness vs. cost of response. The outcome measures of economic evaluations included cost for each life-year gained, the cost for each quality-adjusted life-year (QALY) achieved, and the cost for cases averted with the interventions. In addition, the incremental cost-effectiveness ratio (ICER) was evaluated.
For the analysis, first, the costs were inflated from the original year to 2021, using the gross domestic product (GDP) deflator index of the International Monetary Fund World Economic Outlook Database. Subsequently, the original currency was converted to 2021 Euros, using the Purchasing Power Parities (PPP) values for GDP. The dominance ranking matrix (DRM) was used to assess the cost-effectiveness of the interventions of the selected studies.
Out of 10,314 studies identified, the entire text of 403 full-text studies was screened, from which 362 studies with unmet inclusion criteria were excluded. As a result, 41 studies were selected for the final review, of which 20 studies, 10 studies, and 11 studies were of high, good, and medium quality, respectively. Ten studies assessed the costs of the SARS-CoV-2 pandemic, and 31 studies evaluated the cost-benefits of surveillance, preparedness, and measures taken in response to COVID-19.
In Italy, the temporary and permanent productivity losses due to COVID-19 were estimated at 1,029 per case and 84,836 per death, respectively. Higher costs were incurred during the initial COVID-19 phase due to vaccine unavailability. In Ohio, the cost of lives lost was ~7.8 billion . For children hospitalized due to COVID-19 in Korea, the total costs were 252,389 and for inpatient settings, the cost was estimated at 19,513 during eight months of hospitalization.
The costs were higher (21,850 ) in case of intensive care unit (ICU) admissions without invasive mechanical ventilation (IMV) and even higher (62,139 ) if ICU and IMV are used. Likewise, in Turkey, the cost per ICU patient was much higher than ward patients and was estimated at 2,322 and 700 for 15 days and nine days of hospitalization, respectively.
In Australia, the cost estimates for delays in COVID-19-related cancer treatment initiation by three months and six months were >6 million and >25 million , respectively. In Europe, COVID-19 treatment costs were higher for obese and diabetic individuals. Initiating treatment at an effective reproduction number (Re) of 3.5 was cost-effective from the societal perspective when treating 75% of symptomatic cases (ICER 2,690 /QALY saved) and from the third payer perspective when >50% of all patients were treated (ICER 6,267 /QALY saved).
Quarantine for symptomatic individuals further reduced costs. With home isolation, the costs were estimated at 5% of the US GDP, with maximum cost savings in the case of a 45-day isolation period and 90% compliance. The cost per life-year saved for non-strict and strict physical restriction policies for 26 weeks was 206,888 and 1,553,988 , respectively. For a basic reproduction number (R0) of 2, the optimal strategy was daily testing and 14-day-isolation. On contrary, for lower R0 (1.5 to 1.8) values, weekly testing and one-week isolation were optimal.
Further, community testing, saliva sampling, and testing of all symptomatic individuals improved cost-minimization than standard hospital testing, nasopharyngeal swab sampling, and testing only COVID-19 patients requiring hospitalization. The cost per infection averted by home-based antigen tests was 6,266 and daily screening with subsequent polymerase chain reaction (PCR) tests also reduced costs. Personal protective equipment (PPE) investments of 7.6 billion , dexamethasone treatment, and provision of ICU beds reduced the economic impact of COVID-19.
In Israel, national lockdowns improved health outcomes by reducing deaths; however, the economic burden increased with estimated costs of 36,568,451 per death averted, and 3.6 million costs per QALY gained. Complete lockdown for four months (further extended for three months) resulted in costs of 116 billion and the gradual lifting of restrictions would reduce GDP by 697,121 /life-year saved.
The estimated losses for the three-month mitigation scenario and suppression scenario were 13.5% and 22% in GDP, respectively. Suppression policies were associated with an ICER of <56 972 . In the United States (US), the universal vaccination approach was more cost-saving than the risk-stratification approach from the societal perspective (estimated cost savings of 395 million ); however, the latter was more cost-effective from the healthcare perspective.
Overall, the study findings highlighted the economic burden of SARS-CoV-2 on healthcare systems, societies, the general population, and specific population subgroups and showed that ICU bed provision policies, community screening, vaccination, and investing in PPE were cost-effective in most cases.
medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
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