Two COVID-19 vaccines might be nearing the finish line, but scientists caution it's critical that enough people volunteer to help finish studying other candidates in the U.S. and around the world.
Moderna Inc. and competitor Pfizer Inc. recently announced preliminary results showing their vaccines appear more than 90% effective, at least for short-term protection against COVID-19.
If those early results hold up and U.S. regulators agree the shots are safe, emergency use of small, rationed supplies could start in late December. Other countries with contracts for early doses would undertake their own reviews.
But multiple vaccines will be needed to meet global demand and help end the pandemic, raising concern that studies that still need to sign up thousands of volunteers could run short if people wait for an already OK'd option instead.
We dont want to see that happen, said Dr. James Cutrell, an infectious disease expert at UT Southwestern Medical Center in Dallas.
Supplies aside, other COVID-19 vaccines under development may work differently in different populations and "we likely will benefit from having a menu of vaccine options, Cutrell said.
We still need volunteers, stressed National Institutes of Health Director Francis Collins, urging Americans to sign up.
Additionally, participants in the Moderna and Pfizer studies who originally got dummy shots would almost certainly be offered the real vaccine if the U.S. Food and Drug Administration allows emergency use. But no one knows how long protection would last, meaning those studies also must continue to track recipients somehow.
Its one thing to be effective two months after your last vaccination and another thing to be effective a year later, said Dr. Jesse Goodman of Georgetown University, a former director of the FDA's vaccine division. Its going to be really important to complete these clinical trials and the trials of the other vaccines so we can make comparisons.
The promising Moderna and Pfizer news bodes well for some of their competitors, said Dr. Anthony Fauci, the U.S. government's top infectious disease expert whose team at NIH helped develop the Moderna candidate.
Those shots target the spike protein that studs the surface of the coronavirus, and the early results prove that's enough to generate a protective response, Fauci said. Conceptually this looks good for other spike-focused vaccines made in different ways.
Heres a scorecard of the frontrunners in the global vaccine race:
GENETIC CODE VACCINES
The Moderna-NIH vaccine and the candidate developed by Pfizer and its German partner BioNTech arent made with the coronavirus itself, meaning theres no chance anyone could catch it from the shots.
Instead, the vaccines are made with a brand-new technology that injects a piece of genetic code for the spike protein. That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, enough to prime the immune system to react if it later encounters the real virus.
There are no licensed mRNA vaccines for people, so scientists had no idea if or how well the COVID-19 candidates might work.
Both manufacturers are working to scale up production in factories in the U.S. and Europe. They cant simply partner with other vaccine companies to take on some of the work because the technology is so different than the way most of todays shots are made.
It is not a very easy or quick swap, said Moderna CEO Stphane Bancel.
TROJAN HORSE VACCINES
A different way to target the spike protein: Use another, harmless virus to carry the spike gene into the body. Once again, the body produces some spike protein and primes the immune system.
Britains Oxford University and AstraZeneca are making their version of this viral vector vaccine with a cold virus, or adenovirus, that normally infects chimpanzees. Studies of tens of thousands of people are underway in the U.K., U.S. and several other countries.
Johnson & Johnson is using a human adenovirus for its version, and is the only option in advanced U.S. testing aiming to show if a single dose rather than two would be enough.
Chinas government authorized emergency use of CanSino Biologics adenovirus shots in the military ahead of any final testing. Russia likewise began offering an adenovirus vaccine ahead of late-stage tests.
PROTEIN VACCINES
Novavax makes its vaccine candidate by growing harmless copies of the coronavirus spike protein in the laboratory and packaging them into virus-sized nanoparticles.
There are protein-based vaccines against other diseases, so its not as novel a technology as some of its competitors. Novavax has begun a large final-stage study in Britain, and is set soon to begin another in the U.S.
KILLED VACCINES
Spike-focused vaccines arent the only option. Making vaccines by growing a disease-causing virus and then killing it is a tried-and-true approach its the way Jonas Salks famed polio shots were made.
China has three so-called inactivated COVID-19 vaccine candidates in final testing in several countries, and has allowed emergency use in some people ahead of the results. An Indian company is testing its own inactivated candidate.
Safely brewing and then killing the virus takes longer than newer technologies. But inactivated vaccines give the body a sneak peek at the germ itself rather than just that single spike protein.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.
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Volunteers still needed to test variety of COVID-19 vaccines - ABC News
The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna on Monday, according to an analysis of the final data from their trials, which paves the way for regulators to grant an emergency licence and vaccination campaigns to begin.
The news will excite scientists, public health experts and politicians. Pfizer/BioNTech say they also have the necessary safety data that regulatory bodies require, and will submit the vaccine for emergency approval within days to the US Food and Drug Administration and other regulators around the world.
The Pfizer vaccine, which uses innovative mRNA technology, was the first to publish an early analysis from its phase 3 trials involving 43,000 people worldwide. That analysis of 94 cases of Covid illness showed more than 90% efficacy and caused celebration around the world as it appeared clear that a vaccine was at least possible against the coronavirus that has wreaked havoc in peoples lives and countries economies.
The final results have been published just a week later, based on 170 people in the trial who fell ill with the disease. The new data is even better, with 95% efficacy which means that the vast majority of those who developed symptoms and were confirmed as Covid cases had not been given the Pfizer experimental vaccine. Only eight had been given the vaccine, while the other 162 were in the placebo group.
In further excellent news, a good immune response was consistent across age, gender, race and ethnicity demographics and the jab had over 94% efficacy in those aged over 65, Pfizer said. That is remarkable, because many vaccines do not work so well in older people, whose immune systems weaken with age.
Of those taking part in the trial, 42% were from diverse ethnic backgrounds and 41% were aged between 56 and 85, which is also important as people from BAME groups have been disproportionately affected by the virus.
Ten of the cases resulted in severe illness, as opposed to mild symptoms, and only one of those had been given the experimental vaccine. No serious side-effect issues have been reported, although 2% of people said they suffered a headache and fatigue.
This week, the US company Moderna announced that its vaccine, which also uses mRNA, had 95% efficacy based on interim data. They will now be looking to publish final results and a safety analysis that will allow them to submit for regulatory approval.
Pfizer/BioNTech confirmed they would go within days to regulators around the world for emergency authorisation based on their final data and also manufacturing quality data. They have undertaken to deliver 50m doses of the vaccine this year, with up to 1.3bn next year. The UK has pre-ordered 40m doses and is likely to get a small amount this year. Europe has ordered 200m while the US has ordered 100mn.
We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against Covid-19 can be achieved very fast after the first 30 g [microgam] dose, underscoring the potential of BNT162 to provide early protection, said Uur ahin, the CEO and co-founder of BioNTech.
These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against Covid-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.
I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.
Prof Trudie Lang from the Nuffield Department of Medicine at Oxford University, said the data that has been released looked very positive.
This is a remarkable and very reassuring situation that we find ourselves in. To go from identifying a new virus to having several vaccines at the point of applying for regulatory approval is an incredible milestone for science.
Having worked on vaccine development in several diseases such as Malaria, TB and Ebola, I am really encouraged. The progress here, the faster ways of working and the new technologies developed can be taken forward into other vaccine programmes and benefit other diseases.
Read more:
Pfizer Covid-19 vaccine has 95% efficacy and is safe, further analysis shows - The Guardian
Once a vaccine is approved, the race is on to overcome the biggest logistics challenge in history to distribute it around the globe
By Carrie Arnold
IN KALAMAZOO, Michigan, millions of vials of a covid-19 vaccine may soon be rolling off production lines. There are still many hurdles to leap before that vaccine the candidate from US drug company Pfizer and its German partner BioNTech or any other is approved and distributed, but governments, manufacturers and shipping firms around the world have already spent months preparing for what happens next.
That comes down to a simple but easily overlooked fact: a vaccine by itself is useless. Vaccines dont save lives, says Kelly Moore at the Immunization Action Coalition in the US. Vaccination does.
When a covid-19 vaccine is approved, it will trigger a staggeringly complex chain of events. These events must occur in perfect lockstep using a global supply chain that needs to reach even the planets most remote areas the same supply chain that left parts of the world in desperate need of things like disposable gloves and protective equipment just months ago.
The scale and magnitude of what were talking about doing is just unparalleled, says Orin Levine, director of vaccine delivery at the Bill & Melinda Gates Foundation. The list of potential catastrophes has been keeping Levine up at night for months. But overcoming these logistical challenges is what it will take to end the pandemic. And the key to overcoming complexity is planning and planning early, says Levine.
Exactly how many people need to be vaccinated to end the pandemic depends on how effective the vaccine is, and how long the immunity it provides lasts (see Vaccine front runners ). Seth Berkley, head of Gavi, an international group that promotes
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What will it take to get a covid-19 vaccine to the world? - New Scientist
In the midst of exceptionally positive results from COVID-19 vaccine manufacturers, President Trump has voiced his dissatisfaction with the timing of the news, implying that positive data from clinical trials were deliberately withheld until after Election Day.
Now, The Washington Post reports that the U.S. Department of Health and Human Services (HHS) may release a blueprint to lower drug prices within Medicare through an executive order called the most favored nation.
The most favored nation price refers to the lowest price for a pharmaceutical drug or product sold in a member country of the Organization for Economic Cooperation and Development with a similar gross domestic product.
This policy aims to reduce costs for prescription drugs or biological products, especially for elderly Americans.
The Post notes that the policy is unpopular in the pharmaceutical industry because it would force drug manufacturers to accept the lowest price from the government for medicines that were paid in similarly wealthy countries.
Trump has long wanted to cut drug prices, but has hit roadblocks along the way.
Speaking to The Post, one GOP health care lobbyist said that this move is pointed at pharmaceutical companies like Pfizer and Moderna, whose COVID-19 vaccine candidates each recently revealed about 95 percent efficacy rates.
This is basically Trump being pissed off because he thought the industry campaigned against him and delayed in announcing the [vaccine] results, so he is going to get back at them with favored nations, they said.
PROJECTED US CORONAVIRUS DEATHS MORE THAN 400,000 BY MARCH
PFIZER LAUNCHES TRIAL FOR DELIVERIES OF COVID-19 VACCINE IN FOUR STATES
MODERNAS VACCINE DOESNT NEED TO BE STORED IN DEEP-FREEZE CONDITIONS
MORE THAN 1 MILLION US CHILDREN DIAGNOSED WITH COVID-19: REPORT
See the article here:
If the book of nature is written in the language of mathematics, as Galileo once declared, the Covid-19 pandemic has brought that truth home for the worlds mathematicians, who have been galvanized by the rapid spread of the coronavirus.
So far this year, they have been involved in everything from revealing how contagious the novel coronavirus is, how far we should stand from each other, how long an infected person might shed the virus, how a single strain spread from Europe to New York and then burst across America, and how to flatten the curve to save hundreds of thousands of lives. Modeling also helped persuade the Centers for Disease Control and Prevention that the virus can be airborne and transmitted by aerosols that stay aloft for hours.
And at the moment many are grappling with a particularly urgent and thorny area of research: modeling the optimal rollout of a vaccine. Because vaccine supply will be limited at first, the decisions about who gets those first doses could save tens of thousands of lives. This is critical now that promising early results are coming in about two vaccine candidates one from Pfizer and BioNTech and one from Moderna that may be highly effective and for which the companies may apply for emergency authorization from the Food and Drug Administration.
But figuring out how to allocate vaccines there are close to 50 in clinical trials on humans to the right groups at the right time is a very complex problem, says Eva Lee, director of the Center for Operations Research in Medicine and Health Care at theGeorgia Institute of Technology. Lee has modeled dispensing strategies for vaccines and medical supplies for Zika, Ebola, and influenza, and is now working on Covid-19. The coronavirus is so infectious and so much more deadly than influenza, she says. We have never been challenged like that by a virus.
Howard Forman, a public health professor at Yale University, says the last time we did mass vaccination with completely new vaccines, was with smallpox and polio. We are treading into an area we are not used to. All the other vaccines of the last decades have either been tested for years or were introduced very slowly, he says.
Because Covid-19 is especially lethal for those over 65 and those with other health problems such as obesity, diabetes, or asthma, and yet is spread rapidly and widely by healthy young adults who are more likely to recover, mathematicians are faced with two conflicting priorities when modeling for vaccines: Should they prevent deaths or slow transmission?
The consensus among most modelers is that if the main goal is to slash mortality rates, officials must prioritize vaccinating those who are older, and if they want to slow transmission, they must target younger adults.
Almost no matter what, you get the same answer, says Harvard epidemiologist Marc Lipsitch. Vaccinate the elderly first to prevent deaths, he says, and then move on to other, healthier groups or the general population. One recent study modeled how Covid-19 is likely to spread in six countries the U.S., India, Spain, Zimbabwe, Brazil, and Belgium and concluded that if the primary goal is to reduce mortality rates, adults over 60 should be prioritized for direct vaccination. The study, by Daniel Larremore and Kate Bubar of the University of Colorado Boulder, Lipsitch, and their colleagues, has been published as a preprint, meaning it has not yet been peer reviewed. Of course, when considering Covid-19s outsized impact on minorities especially Black and Latino communities additional considerations for prioritization come into play.
Most modelers agree that everything is changing with coronavirus at the speed of light, as applied mathematician Laura Matrajt, a research associate at the Fred Hutchinson Cancer Research Center in Seattle, put it in an email. That includes our understanding of how the virus spreads, how it attacks the body, how having another disease at the same time might raise the risk, and what leads to super-spreader events.
Because vaccine supply will be limited at first, the decisions about who gets those first doses could save tens of thousands of lives.
So far, the research has yielded some surprising results. While children are usually prioritized for flu vaccine, for example, experts say the very young should be a lower priority for Covid-19 vaccines in the United States, because thus far young adults have been primary drivers of transmission. (This is not necessarily true across the globe; in India, for instance, where multiple generations often live together in smaller spaces, new research shows both children and young adults are spreading much of the virus in the two states studied.)
In addition, several models suggest that significant headway can be made against the pandemic even with lower deployment of a vaccine that is only partly effective. And several others emphasize the importance of local infection and transmission rates. According to Lee, whose early assessments of the pandemics origin, virulence, and probable global trajectory proved to be strikingly accurate, New York could potentially contain the virus if about 40 percent of the population were vaccinated, because local transmission of the virus is fairly low (a positivity rate of a little below 3 percent as of Nov. 16), and around 20 percent have already been infected.
The higher the fraction of people in the population who already have antibodies, the more bang for your buck, says Larremore, because you can prioritize giving vaccines to those who dont have antibodies.
All these findings are important because, at the end of the day, you will never have enough vaccines for the entire population, says Lee and not all Americans will take it. In fact, the World Health Organization recently predicted that healthy young adults may not even be able to get a vaccine until 2022, after the elderly, health care workers, and other high-risk groups are vaccinated.
To model the rollout of vaccines, mathematicians must build formulas that reflect the starburst of human life and our complex interactions, using data like housing and socioeconomic status, daily habits, age, and health risks. But first they establish how contagious the virus is its reproductive rate, or R-naught. This represents the number of people that one infected person can be expected to transmit the infection to.
When some fraction (depending on R-naught) of people are immune (either by recovering from natural infection, if that grants immunity, or through vaccination), herd immunity has been achieved. That means that while small outbreaks may still occur, the pandemic will not take off globally again. Given the R-naught of SARS-CoV-2, the virus that causes Covid-19, the World Health Organization has estimated that 65 percent to 70 percent of the population needs to be immune before this can be achieved.
Modeling vaccine rollout requires a complex acrobatics, and while the models to flatten the curve that mesmerized the public last spring took weeks to craft, vaccine distribution models take many months. There are innumerable practical challenges facing modelers. For one thing, many of the vaccines currently in the pipeline including the two candidates from Pfizer and BioNTech and Moderna require two shots, several weeks apart, which involve registries and follow-up to ensure that people get the second, critical booster shot. And as The New York Times noted in late September, Companies may have to transport tiny glass vials thousands of miles while keeping them as cold as the South Pole in the depths of winter.
There is also the question of vaccine efficacy. Will a given vaccine provide robust immunity, and in all groups? Or will it primarily shorten duration of infection and lessen symptoms, which would still be of great value in reducing mortality as well as transmission? And what if a vaccine is less effective among the elderly, as is often the case? At the moment, vaccines using messenger RNA (including those produced by Moderna and Pfizer and BioNTech) are looking pretty good in older adults, according to Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine. Preliminary analyses of both vaccine candidates show that they may be more than 90 percent effective.
Finally, there is also the vexing question of how long immunity might last after infection. For some viruses, such as the varicella-zoster virus that causes chickenpox, immunity can last for decades. For others, such as the family of coronaviruses that includes SARS-CoV-2 and the common cold, the virus has a relatively high mutation rate that may protect novel strains from our antibodies. That uncertainty is difficult to model precisely, so many modelers assume that, for the time being at least, those who have been infected are immune.
Matrajt, of the Fred Hutchinson Cancer Center in Seattle, remembers vividly how hard it was to begin to construct a model out of thin air when she began working with colleagues on a vaccination model this past April. There were so many uncertainties, she recalls. Together, the researchers developed algorithms based on an astonishing 440 or so combinations of parameters, from transmission to immunity to age groups and mortality. Their computers spent nearly 9,000 hours running equations, and their model, published in August as a preprint, shows that if there is only a low supply of vaccine at first, older adults should be prioritized if the goal is to reduce deaths.
But for vaccines that are at least 60 percent effective, once there is enough to cover at least half the population, switching to target healthy individuals ages 20 to 50 as well as children would minimize deaths. The model also predicts how many deaths can be averted with different amounts of vaccine coverage. For instance, if 20 percent of the population has already been infected and is immune, deaths could be halved by vaccinating just 35 percent of the remainder, if the vaccine is at least 50 percent effective.
In the model by Matrajt and her colleagues, herd immunity is achieved once 60 percent of the population is immune. It is completely normal that different models will give different numbers, she says, explaining why her estimate varies slightly from the WHO figure of 65 percent.
The model does a really nice job looking at a large number of plausible cases, says Michael Springborn, an environmental and resource economist at the University of California, Davis, who just finished his own model with Jack Buckner, a colleague at UC Davis, and Gerardo Chowell, a mathematical epidemiologist at Georgia State University. Their study, released in preprint, also suggests the power of careful initial targeting in reducing deaths.
The models suggest that even a partially-effective vaccine given to just part of the population, says Springborn, can go a really long way to reducing infections and reducing deaths.
Lees modeling, created with software she first developed in 2003, in conjunction with the CDC, for dispensing of supplies in natural disasters and pandemics, analyzes how the disease might be contained in areas with different infection rates and initially scarce vaccine supplies. In New York City, which was hit so hard in the spring, her model predicts that roughly 60 percent of the population may need immunity to contain the pandemic. Assuming 20 percent are already infected, about 40 percent would need to be vaccinated. In San Diego, however, where infection rates have been lower, Lees model suggests that 65 percent will need to achieve immunity through infection or vaccination. In Houston, the figure may be as high as 73 percent because the infection has persisted at a slow burn and because of the citys large, vulnerable Latino and African American populations, who have borne disproportionate risk.
Lee cautions that these results do not mean you can suddenly go to a football game in Houston or Broadway show in New York, but it does mean that with ongoing precautions, the virus might well be contained with the percentages given in her models, until more vaccine arrives.
Though their results vary, most models agree that certain factors are critical, notably age group, which changes the risk of contracting, spreading, and dying from a virus. Its not always predictable: The swine flu, for instance, spared older adults to some degree, while SARS-CoV-2 has severely affected those over 65. Adults 65 and older compose 16 percent of the U.S. population but account for about 80 percent of Covid-19 deaths.
In addition, age indirectly influences transmission patterns. In 2009, Yale epidemiologists Alison Galvani and Jan Medlock published a mathematical model in Science, showing that targeting flu vaccines to children and young adults (in addition to the elderly) could have slashed swine flu infections from 59 million to 44 million; and for seasonal influenza, 83 million infections could plunge to 44 million. Children, it turns out, drive a disproportionate amount of flu transmission, and protecting them protects society at large.
The study, and others like it, inspired a change in CDC policy to prioritize vaccinating children. It was a revolution in how we think about vaccines, says Larremore. Vaccination models now routinely consider the power of indirect protection of the most vulnerable by vaccinating those most responsible for spread.
Age also intersects, in complex ways, with social connectivity in different regions. For instance, African American and Latino communities in the United States have been disproportionately hit by Covid-19, in part because of the prevalence of multiple generations living together: Older individuals are much more exposed to the young adults who might be the likeliest carriers of infection.
Modeling connectivity requires drawing grids that represent how we live and move among each other. In 2008, a landmark paper built a grid that epidemiologists everywhere still use today. It stratified people into groups based on age, from birth to 70 years old and up. In the study, more than 7,000 individuals kept a diary of their contacts nearly 98,000 of them over the course of one day. Contacts were sorted by place (home, school, work, leisure) and by nature (physical or nonphysical, brief or longer lasting). The model found that 5- to 19-year-olds tend to experience the highest incidence of infection when a new pathogen begins to spread in a completely susceptible population, possibly because of their more frequent and physical contact with others. It also showed how profoundly a societys grids of connection influence transmission.
The model was expanded globally in 2017, with contact rates for 152 countries. Its what we all use, says Matrajt, because its the best thing we have to identify how people contact each other. She incorporated the contact grid into her model.
For example, if kids are really the hubs around which society is built, Larremore says, so that if you vaccinate the kids, you fragment that transmission network, then thats going to give us a totally different way of rolling out this vaccine.
The original grid relied on diaries. Today, our ability to gather data through real time cellphone and online activity may be even greater.
When social distancing became widespread this past spring, it dramatically altered the input into the typical transmission model, says Springborn. Data from the Institute for Health Metrics and Evaluation at the University of Washington shows the power of social distancing in reducing transmission. The contact grids in previous studies are from pre-pandemic times, Springborn wrote in an email. We know that contact rates are very different under social distancing and we want to account for that. And we expect social distancing to soften as the number of infections falls. Human nature: As risk falls, so does risk-mitigating behavior.
That needs to be modeled as well. And it will influence the expectations for a vaccines rollout and success. In fact, Lee maintains, if we had 90 percent compliance with face masks and social distancing right now, we could contain the virus without a vaccine.
If kids are really the hubs around which society is built, Larremore says, so that if you vaccinate the kids, you fragment that transmission network, then thats going to give us a totally different way of rolling out this vaccine.
In the study by Springborn, Buckner, and Chowell, social distancing is modeled by creating age-stratified categories for both essential and nonessential workers. Essential workers health care workers, grocery workers, and many schoolteachers, among others are at high risk for infection because they cannot socially distance. This model finds that deaths, as well as total years of life lost, are dramatically decreased when essential workers are prioritized to receive the vaccine. Older essential workers between 40 and 59 should be prioritized first if the goal is to minimize deaths, the authors maintain.
With no vaccine, about 179,000 people may die in the first six months of 2021, Springborn says. His teams model suggests that deaths could decline to about 88,000 simply by introducing a vaccine gradually, giving it to 10 percent of the population each month, and distributing it uniformly without prioritizing any groups. But distributing vaccines in a targeted way, based on peoples ages and whether they are essential workers, could save another 7,000 to 37,000 lives, depending on the situation.
There are other methods of teasing out social connectivity beyond diaries and cellphone data. Census and other data reflect age, profession, and socioeconomic status, and Lee includes them in her models. The zip code gives you a huge amount of information, she says. Public health data on disease prevalence and hospitalizations can tease out the other unrelated diseases that Covid-19 patients have, as well as vulnerabilities in a given area. Even information on a citys housing, whether skyscrapers or single-family homes, can give a clue to how closely people are packed together and how likely they are to interact. Inputting this kind of data allows for a vaccine rollout that is sensitive to local conditions. Lee would need to model about 500 representative cities around the U.S., she says, to cover the country accurately.
As powerful as the models can be, they are an imperfect guide. Inevitably they intersect with deep and broad social concerns. The pandemic has disproportionately harmed and killed minorities and those with lower incomes. For that reason, various groups are looking into the ethical principles that should frame vaccine allocation, according to Hanna Nohynek, deputy head of the Infectious Diseases Control and Vaccinations Unit at the Finnish Institute for Health and Welfare, and a member of the WHOs SAGE Working Group on Covid-19 vaccines.
In the U.S., the National Academies of Sciences, Engineering, and Medicine has begun to model an equitable allocation of a vaccine. In addition, two other important models have emerged, one associated with University of Pennsylvania School of Medicine, and the other with Johns Hopkins University. Both are guided by concerns about ethics, fairness, maximizing benefits, building trust and the greater public good.
But building trust can be challenging in practice. For instance, its widely acknowledged that Black people have experienced hospitalization and death at disproportionately high rates compared to White people. Yet when ethicists begin to talk about prioritizing Black people for vaccines, it can be perceived as an intent to experiment on them by pushing them to the head of the line. If there is concern among African Americans, its a logical reaction to a vast history of centuries of abuse of African Americans in the medical sphere, says medical ethicist Harriet Washington, author of Medical Apartheid.
Ultimately, both ethical and mathematical models have to face real-world practicalities. Its hard because math essentially boils down to a utilitarian calculus, says Lipsitch, the Harvard epidemiologist.
Nonetheless, says Larremore, the models will help guide us in the uncertain early days. Vaccines take a while to roll out, he says. We cant let our foot off the gas the moment a vaccine is announced.
Jill Neimark is a writer based in Atlanta, Georgia, whose work has been featured in Discover, Scientific American, Science, Nautilus, Aeon, NPR, Quartz, Psychology Today, and The New York Times. Her latest book is The Hugging Tree (Magination Press).
Excerpt from:
What Is the Best Strategy to Deploy a Covid-19 Vaccine? - Undark Magazine
The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna on Monday, according to an analysis of the final data from their trials, which paves the way for regulators to grant an emergency licence and vaccination campaigns to begin.
The news will excite scientists, public health experts and politicians. Pfizer/BioNTech say they also have the necessary safety data that regulatory bodies require, and will submit the vaccine for emergency approval within days to the US Food and Drug Administration and other regulators around the world.
The Pfizer vaccine, which uses innovative mRNA technology, was the first to publish an early analysis from its phase 3 trials involving 43,000 people worldwide. That analysis of 94 cases of Covid illness showed more than 90% efficacy and caused celebration around the world as it appeared clear that a vaccine was at least possible against the coronavirus that has wreaked havoc in peoples lives and countries economies.
The final results have been published just a week later, based on 170 people in the trial who fell ill with the disease. The new data is even better, with 95% efficacy which means that the vast majority of those who developed symptoms and were confirmed as Covid cases had not been given the Pfizer experimental vaccine. Only eight had been given the vaccine, while the other 162 were in the placebo group.
In further excellent news, a good immune response was consistent across age, gender, race and ethnicity demographics and the jab had over 94% efficacy in those aged over 65, Pfizer said. That is remarkable, because many vaccines do not work so well in older people, whose immune systems weaken with age.
Of those taking part in the trial, 42% were from diverse ethnic backgrounds and 41% were aged between 56 and 85, which is also important as people from BAME groups have been disproportionately affected by the virus.
Ten of the cases resulted in severe illness, as opposed to mild symptoms, and only one of those had been given the experimental vaccine. No serious side-effect issues have been reported, although 2% of people said they suffered a headache and fatigue.
This week, the US company Moderna announced that its vaccine, which also uses mRNA, had 95% efficacy based on interim data. They will now be looking to publish final results and a safety analysis that will allow them to submit for regulatory approval.
Pfizer/BioNTech confirmed they would go within days to regulators around the world for emergency authorisation based on their final data and also manufacturing quality data. They have undertaken to deliver 50m doses of the vaccine this year, with up to 1.3bn next year. The UK has pre-ordered 40m doses and is likely to get a small amount this year. Europe has ordered 200m while the US has ordered 100mn.
We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against Covid-19 can be achieved very fast after the first 30 g [microgam] dose, underscoring the potential of BNT162 to provide early protection, said Uur ahin, the CEO and co-founder of BioNTech.
These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against Covid-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.
I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.
Prof Trudie Lang from the Nuffield Department of Medicine at Oxford University, said the data that has been released looked very positive.
This is a remarkable and very reassuring situation that we find ourselves in. To go from identifying a new virus to having several vaccines at the point of applying for regulatory approval is an incredible milestone for science.
Having worked on vaccine development in several diseases such as Malaria, TB and Ebola, I am really encouraged. The progress here, the faster ways of working and the new technologies developed can be taken forward into other vaccine programmes and benefit other diseases.
Visit link:
Pfizer Covid-19 vaccine has 95% efficacy and is safe, further analysis shows - The Guardian
CHICAGO The city could get its first doses of a coronavirus vaccine by the end of the year, with health care workers first in line.
Still, the vaccine likely wont be widely available to the general public until months into 2021, Dr. Allison Arwady, head of the Chicago Department of Public Health, said during a Tuesday news conference.
I think it is likely we may see the first emergency-use FDA authorization in the next few weeks, Arwady said. If that happens, I think its likely we could have our first COVID-19 vaccine here in Chicago before the end of the year.
Demand for a vaccine is high internationally, and supply and distribution will be highly limited. Officials will prioritize giving the few doses they get in the beginning to health care workers, particularly those working with COVID-19 patients, Arwady said. She said Chicago has about 150,000 health care workers.
After that, first responders and people living in long-term care facilities which have seen numerous deadly outbreaks will get the vaccine.
Only then will the vaccine likely start going out more widely. Its possible the general public could have access to it in the first quarter of 2021, Arwady said.
We dont know [the timeline] for a fact, she said. We will only know that when the vaccine trials are appropriately completed, when the FDA has completed its review and then the CDC also looks at the data and theres an external group of scientists that make recommendations about who should receive this vaccine.
Children likely wont get vaccinated for months since more research needs to be done and since they havent faced the same risks as older people from COVID-19, Arwady said.
The Department of Public Health has already begun building up how many doses of vaccine it can store at once and working with hospitals so they can distribute the vaccine once its more widely available.
The vaccines being trialed will go through all of the appropriate scientific review before theyre distributed widely, Arwady said, and she will not OK their use in Chicago without ensuring theyre safe.
But Arwady said even once the general public starts getting vaccinated, people will still need to wear masks and social distance.
A vaccine is not going to be here for most people within the next few months, Arwady said.
Its going to be months before we have the amount of vaccine [where] we start talking about vaccinating hundreds of thousands or 2.7 million Chicagoans, Arwady said. Throughout most of 2021, even as the vaccine is being rolled out, we are going to need people to keep wearing their masks, to keep social distancing. Even the people who have received the vaccine.
Thats because researchers still need to study the virus and ensure vaccinated people arent still shedding the virus, potentially spreading it to others, Arwady said.
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With the pandemic cutting an ever-broadening swath through the country, Modernas announcement that preliminary data indicate its COVID-19 vaccine was 95% effective offered Americans a much-needed shot of hope.
It was the second time in as many weeks that independent safety monitors had examined clinical trial data and determined that an experimental vaccine was performing above expectations. Last week Pfizer, in collaboration with its German partner BioNTech, said its vaccine was 90% effective in preventing symptoms of the disease.
The light at the end of the tunnel is getting a little brighter, said Dr. William Schaffner, an infectious disease and preventive medicine expert at Vanderbilt University.
The news comes as multiple states issued new lockdown orders in an effort to stop a third wave of coronavirus infections. More than a million new cases were recorded last week alone, and more than 1,100 Americans are dying each day.
Pfizer and Moderna have yet to release detailed data from this final stage of clinical trials, and the results may change by the time theyre complete. But many experts are optimistic that initial distribution of these vaccines could begin by years end.
The results from Pfizer, and now Moderna, gives me a great deal of encouragement, said Dr. Buddy Creech, director of the vaccine research program at Vanderbilt University Medical Center. The effectiveness levels are beyond our expectations, giving us firm hope that we will see an end to the pandemic once widespread vaccination is possible.
Heres a closer look at where things stand with these front-running vaccines.
The clinical trials are measuring how good experimental vaccines are at reducing a persons risk of becoming infected with the coronavirus that causes COVID-19.
To do this, researchers recruited volunteers who were given two doses of either the vaccine or a placebo without knowing which was which. Then they were encouraged to continue everyday activities.
The trials were designed for an assessment to be made after a pre-specified number of volunteers came down with COVID-19. The Moderna trial, for instance, enrolled 30,000 participants and planned to stop after 151 cases were recorded. So far, 95 individuals have become sick, which was enough for the data monitoring board to provide an early assessment of the vaccines efficacy. Participants will continue to be evaluated to see how the vaccine performs over time.
The conclusion was that after three months of exposure in typical communities around the country, about 29,900 individuals in the Moderna trial remained symptom free. Of the 95 who became ill with COVID-19, 90 were in the placebo group, and five had received the vaccine.
This information allowed the review board to conclude that the vaccine had 94.5% effectiveness. The data are still being evaluated to determine why 5% of those inoculated with the vaccine got ill.
The numbers are similar to the Pfizer trial, which enrolled 44,000 people. However, unlike Moderna, Pfizer did not provide information about disease severity among participants.
The stunning and hopeful news is that the vaccine had an important and positive effect in reducing getting sick, said Dr. Larry Steinman, professor of pediatrics and neurological sciences at Stanford University who was chair of the immunology department program for 10 years.
Researchers need something to compare their vaccine against so they can assess whether its better or worse than doing nothing. In this case, the placebo is merely a saline solution.
But its not only the participants who are kept in the dark about whether they got the experimental treatment or the placebo. The researchers who examine the participants are blinded as well. That way, when they assess a volunteers health, they arent influenced by the knowledge that he or she got or didnt get the experimental vaccine.
Placebo-controlled trials are the best way to take bias out of the equation, said Vanderbilts Creech. They allow us to see how well a vaccine works. By randomizing and by staying blinded as to what a volunteer received, we are able to more fairly judge whether the vaccine works.
The study design also helps researchers identify side effects caused by the vaccine. For instance, if those who received the placebo complained of sore arms as much as those who got the vaccine, it would be reasonable to conclude that the soreness is the result of the needle and not necessarily due to the vaccines active ingredients.
More time is needed for more study participants to become sick. The more cases there are, the more certain researchers can be about saying the outcomes for the two groups of volunteers are different and that the vaccine performed better than the placebo.
Some side effects may take awhile to develop as well, and the trial has to last long enough to give them a chance to crop up.
In general, clinical trials may be stopped ahead of schedule if the early data make it obvious that an experimental medication is completely ineffective, or when the results are so favorable that it is no longer ethically responsible to deny it to those who got the placebo.
Theyve all been minimal. Some participants have reported a sore arm for a day or two. Some complained of headaches and fatigue, as well as general muscle aches and pain. None of these is considered a severe adverse reaction.
Even trials of this size might not be able to detect very rare adverse events, which is why even after a vaccine is approved, monitoring systems continue to look for these rare events in the broader population.
These clinical trials were designed as two-year studies, so its not clear when the final results will be available.
But final results are not necessary for the Food and Drug Administration, which is tasked with vetting new medications for public use, to decide whether to grant any COVID-19 vaccine an Emergency Use Authorization and allow it to be made available to the public. If such an authorization is given, then vaccines could start to be distributed by December.
Vaccines being developed by AstraZeneca and Johnson & Johnson are also considered viable contenders.
Both are in the late-stage clinical trials, with enrollment continuing around the world. These vaccines are made slightly differently from the ones from Pfizer and Moderna, but because they target the same protein on the surface of the virus, we have a lot of confidence that they may enjoy similar efficacy, Creech said.
If the FDA issues an Emergency Use Authorization, the Centers for Disease Control and Prevention will be in charge of overseeing the vaccines distribution to the public. States will develop their own plans as well. While theres still a lot of uncertainty, its already clear that there wont be enough vaccines to go around at first.
Early prioritization schemes put healthcare workers at the front of the line. Theyll be joined by older individuals and those with underlying medical conditions, because people in these groups are more likely to become severely ill if they are infected.
Both Pfizer and Moderna have publicly reported that they will have about 20 million doses by the end of the year, but experts believe it will take until late spring or early summer to produce enough vaccine to immunize a majority of U.S. residents.
But experts say that public health protocols such as wearing masks and maintaining social distance must remain in place for months or even years after vaccines first become available.
What remains to be answered is whether these vaccines will keep people from getting infected. As promising as these trials are, it is not known if the vaccine will stop the spread of the virus.
View original post here:
Moderna and Pfizer COVID-19 vaccines: What you need to know - Los Angeles Times
With the pandemic cutting an ever-broadening swath through the country, Modernas announcement that preliminary data indicate its COVID-19 vaccine was 95% effective offered Americans a much-needed shot of hope.
It was the second time in as many weeks that independent safety monitors had examined clinical trial data and determined that an experimental vaccine was performing above expectations. Last week Pfizer, in collaboration with its German partner BioNTech, said its vaccine was 90% effective in preventing symptoms of the disease.
The light at the end of the tunnel is getting a little brighter, said Dr. William Schaffner, an infectious disease and preventive medicine expert at Vanderbilt University.
The news comes as multiple states issued new lockdown orders in an effort to stop a third wave of coronavirus infections. More than a million new cases were recorded last week alone, and more than 1,100 Americans are dying each day.
Pfizer and Moderna have yet to release detailed data from this final stage of clinical trials, and the results may change by the time theyre complete. But many experts are optimistic that initial distribution of these vaccines could begin by years end.
The results from Pfizer, and now Moderna, gives me a great deal of encouragement, said Dr. Buddy Creech, director of the vaccine research program at Vanderbilt University Medical Center. The effectiveness levels are beyond our expectations, giving us firm hope that we will see an end to the pandemic once widespread vaccination is possible.
Heres a closer look at where things stand with these front-running vaccines.
The clinical trials are measuring how good experimental vaccines are at reducing a persons risk of becoming infected with the coronavirus that causes COVID-19.
To do this, researchers recruited volunteers who were given two doses of either the vaccine or a placebo without knowing which was which. Then they were encouraged to continue everyday activities.
The trials were designed for an assessment to be made after a pre-specified number of volunteers came down with COVID-19. The Moderna trial, for instance, enrolled 30,000 participants and planned to stop after 151 cases were recorded. So far, 95 individuals have become sick, which was enough for the data monitoring board to provide an early assessment of the vaccines efficacy. Participants will continue to be evaluated to see how the vaccine performs over time.
The conclusion was that after three months of exposure in typical communities around the country, about 29,900 individuals in the Moderna trial remained symptom free. Of the 95 who became ill with COVID-19, 90 were in the placebo group, and five had received the vaccine.
This information allowed the review board to conclude that the vaccine had 94.5% effectiveness. The data are still being evaluated to determine why 5% of those inoculated with the vaccine got ill.
The numbers are similar to the Pfizer trial, which enrolled 44,000 people. However, unlike Moderna, Pfizer did not provide information about disease severity among participants.
The stunning and hopeful news is that the vaccine had an important and positive effect in reducing getting sick, said Dr. Larry Steinman, professor of pediatrics and neurological sciences at Stanford University who was chair of the immunology department program for 10 years.
Researchers need something to compare their vaccine against so they can assess whether its better or worse than doing nothing. In this case, the placebo is merely a saline solution.
But its not only the participants who are kept in the dark about whether they got the experimental treatment or the placebo. The researchers who examine the participants are blinded as well. That way, when they assess a volunteers health, they arent influenced by the knowledge that he or she got or didnt get the experimental vaccine.
Placebo-controlled trials are the best way to take bias out of the equation, said Vanderbilts Creech. They allow us to see how well a vaccine works. By randomizing and by staying blinded as to what a volunteer received, we are able to more fairly judge whether the vaccine works.
The study design also helps researchers identify side effects caused by the vaccine. For instance, if those who received the placebo complained of sore arms as much as those who got the vaccine, it would be reasonable to conclude that the soreness is the result of the needle and not necessarily due to the vaccines active ingredients.
More time is needed for more study participants to become sick. The more cases there are, the more certain researchers can be about saying the outcomes for the two groups of volunteers are different and that the vaccine performed better than the placebo.
Some side effects may take awhile to develop as well, and the trial has to last long enough to give them a chance to crop up.
In general, clinical trials may be stopped ahead of schedule if the early data make it obvious that an experimental medication is completely ineffective, or when the results are so favorable that it is no longer ethically responsible to deny it to those who got the placebo.
Theyve all been minimal. Some participants have reported a sore arm for a day or two. Some complained of headaches and fatigue, as well as general muscle aches and pain. None of these is considered a severe adverse reaction.
Even trials of this size might not be able to detect very rare adverse events, which is why even after a vaccine is approved, monitoring systems continue to look for these rare events in the broader population.
These clinical trials were designed as two-year studies, so its not clear when the final results will be available.
But final results are not necessary for the Food and Drug Administration, which is tasked with vetting new medications for public use, to decide whether to grant any COVID-19 vaccine an Emergency Use Authorization and allow it to be made available to the public. If such an authorization is given, then vaccines could start to be distributed by December.
Vaccines being developed by AstraZeneca and Johnson & Johnson are also considered viable contenders.
Both are in the late-stage clinical trials, with enrollment continuing around the world. These vaccines are made slightly differently from the ones from Pfizer and Moderna, but because they target the same protein on the surface of the virus, we have a lot of confidence that they may enjoy similar efficacy, Creech said.
If the FDA issues an Emergency Use Authorization, the Centers for Disease Control and Prevention will be in charge of overseeing the vaccines distribution to the public. States will develop their own plans as well. While theres still a lot of uncertainty, its already clear that there wont be enough vaccines to go around at first.
Early prioritization schemes put healthcare workers at the front of the line. Theyll be joined by older individuals and those with underlying medical conditions, because people in these groups are more likely to become severely ill if they are infected.
Both Pfizer and Moderna have publicly reported that they will have about 20 million doses by the end of the year, but experts believe it will take until late spring or early summer to produce enough vaccine to immunize a majority of U.S. residents.
But experts say that public health protocols such as wearing masks and maintaining social distance must remain in place for months or even years after vaccines first become available.
What remains to be answered is whether these vaccines will keep people from getting infected. As promising as these trials are, it is not known if the vaccine will stop the spread of the virus.
Original post:
Moderna and Pfizer COVID-19 vaccines: What you need to know - Los Angeles Times
