While the vaccines for Covid-19 seem to have been created in record time, the technology making them possible has been decades in development. The two vaccine candidates produced by Pfizer/BioNTech and Moderna are unlike any other vaccine that’s come before. Should they achieve commercial success, it could usher in a new era of medical science — not just for vaccines, but for cancer treatments, blood disorders, and gene therapy.
The two new vaccines are the first ever to use mRNA, which stands for “messenger RNA,” to generate immunity. Historically, vaccines have used dead or weakened viruses to imitate an infection, spurring the body to make antibodies against that virus without danger of getting sick. Measles, polio, and some seasonal flu shots are examples of vaccines made with whole virus particles.
Other vaccines use only certain fragments of the virus, called antigens, that provoke an immune response. To make this type of vaccine, the genetic code for the desired viral antigen molecule is put into yeast or bacteria cells. These microbes can be grown rapidly and inexpensively, and they can churn out massive quantities of antigen. Then the molecule must be purified to clinical standards so that it’s safe to inject into healthy people. Prevnar and Gardasil are examples of this type of vaccine.
These methods work well, but they require enormous research and development efforts. A laboratory could spend years optimizing the methods for producing one virus protein, but those methods wouldn’t automatically translate to mass-producing a different protein.
“For every new protein, you start over. It’s a brand-new procedure every step of the way,” explains immunologist Drew Weissman of the Perelman School of Medicine at the University of Pennsylvania. Weissman is one of the pioneering scientists behind the mRNA vaccine.
“The way I see it, the mRNA platform is much better, it’s much quicker, and it’s cheaper,” says Weissman. “That’s the trilogy of what you need to improve vaccines.” With mRNA, the steps are the same, no matter what virus the vaccine is targeting. This makes it easily customizable. Once an mRNA manufacturing facility is up and running, it can easily be deployed to make vaccines against any number of viral antigens.
How is that possible? Here’s how it works
A strand of mRNA carries the instructions for making one protein. Your cells normally make their own mRNA strands and use them as blueprints to manufacture all the proteins your body needs to function.
The vaccine slips a new strand of mRNA into the cell, like an extra page in the blueprint. This mRNA contains the instructions for making the coronavirus spike protein, and the cell reads it the same way it reads its own mRNAs, using it to build the viral protein. The immune system recognizes that protein as foreign, and starts making antibodies against it. Then, if you’re exposed
MIAMI – Registered clinical trials reached record levels in the past year, increasing the demand for people willing to participate, and Miami resident Marilyn Strauss Diaz was eager to join a COVID-19 vaccine trial underway at the University of Miami Health System.
“We can’t depend on a lab rat. We have to have human trials for there to be a successful vaccine, so we have to have humans come forward and be a part of trials,” she said.
“Before COVID, we usually would have a couple of hundred clinical trials here going at the same time at the University of Miami that are focused on a lot of different diseases. With COVID, there was a slowdown and now we’re ramping up again and starting a lot of these studies,” said Dr. Olveen Carassquillo, who is part of the research team.
“COVID has the most urgency. That’s a public health crisis so a lot of research is focused on that, but we have a lot of landmark cancer studies going on with different treatment regimens and prevention studies. We also have a lot of cardiovascular disease, a lot of other studies focused on stroke, on preventing dementia,” Carassquillo added.
And South Florida’s diverse population makes it a major focus of research efforts, something Strauss Diaz is proud to be a part of.
“At the end, it will be beneficial to so many,” she said.
To learn more about clinical trials at the University of Miami Health System go to: https://umiamihealth.org/clinical-trials
Copyright 2020 by WPLG Local10.com – All rights reserved.Read More
Stanford Medicine has joined a large, Phase 3 clinical trial of an experimental vaccine against COVID-19.
The trial will test whether the vaccine, which is produced by the Janssen Pharmaceutical Companies of Johnson & Johnson, protects people from the disease. It will enroll some 60,000 people at about 180 sites around the world. The Stanford site is expected to enroll about 1,000 participants.
Participants will receive either the vaccine or a placebo, and their health and immune responses will be monitored for about one year after their initial visits. If any participants become ill with symptoms of COVID-19, a health care provider will go to their homes to assess their health and collect a nasal sample to test for the presence of the novel coronavirus. If they are infected, Stanford physicians will monitor their disease progression.
“We’re enrolling a wide variety of participants, but we are particularly interested in those who feel like their home or workplace exposure puts them at risk,” said Philip Grant, MD, assistant professor of medicine and the trial’s principal investigator at Stanford. “Teachers, grocery store workers, people who live in multigenerational households, health care workers and students on campus would all be good candidates for participation.”
Participants will be followed for two years and one month. They are expected to visit the trial site eight times: six in the first year and two in the second year. The initial visit will last about two hours; subsequent visits will consist of a short blood draw and symptom screening. If a participant develops COVID-19 during the study period, additional visits may be required.
The vaccine unit opening comes as global coronavirus infections are rising sharply, with nearly 200,000 cases reported daily in the United States. Montefiore’s goal is to ensure more than half of all trial participants are adults most affected by COVID-19 with a focus on people older than 65. Across the country, older individuals and communities of color have been disproportionately impacted by the pandemic.
“Montefiore and Einstein have a legacy of providing inclusive access to cutting edge care,” said Andrew D. Racine, M.D., Ph.D., system senior vice president and chief medical officer at Montefiore and professor of pediatrics at Einstein. “By ensuring that historically underrepresented patients are included in COVID-19 vaccination research, this effort will help ensure the efficacy and safety of vaccines for these underrepresented patient groups.”
The new vaccine unit builds on Montefiore and Einstein’s leadership conducting COVID-19 trials and providing lifesaving clinical care to thousands of people in the community and has already started enrolling people in the AstraZeneca-Oxford vaccine AZD1222 trial. Dr. Zingman is the principal investigator at Montefiore for the vaccine, which is one of 13 COVID-19 vaccines in phase III trials and the first to be evaluated at Montefiore and Einstein. He was also the principal investigator at Montefiore and Einstein for the ACTT-1 and ACTT-2 National Institutes of Health trials, which evaluated remdesivir (now FDA-approved as a treatment for people hospitalized with COVID-19) and remdesivir plus baricitinib, respectively.
Since March, physician-scientists at Montefiore and Einstein have studied COVID-19’s impact on almost every major health condition, ranging from asthma to cancer; examined health inequities in local communities; and helped determine which treatments work best against COVID-19.
Among its notable research, Montefiore and Einstein faculty:
– Published the first major U.S. study on the use of steroids, which confirmed the findings of the large-scale British RECOVERY trial showing that steroids are effective in treating COVID-19; the study also revealed which patients can be harmed by steroids
– Led the first-ever study comparing the immune responses of adults and children with COVID-19 and detected key differences that may explain why children have milder disease than adults
– Led the development of a monoclonal antibody therapy to neutralize COVID-19—and potentially other emerging coronaviruses—clinical trials will begin in December
– Created a blood test for detecting COVID-19 antibodies, used clinically and for research
– Launched the first randomized, placebo-controlled, double-blind trial of convalescent plasma with NYU Langone Medicine Center, which has expanded to include the University of Miami and the University of Texas-Houston, among other locations across the country
– Was the first New York City medical center to enroll participants in the ACTT-1 remdesivir trial and the second highest enrolling site worldwide
– Will offer the first randomized controlled trial of dexamethasone versus baricitinib (NIAID ACTT-4 study) for the hyperinflammatory state in COVID-19
“Words cannot express my appreciation for the many people who worked so hard to establish the new COVID-19 vaccine unit, making sure underrepresented communities will have access to the most promising
LONDON, Nov 23 (Reuters) – Britain medicines regulator said on Monday it would aim to make a decision on Pfizer and BioNTech’s COVID-19 vaccine candidate “in the shortest time possible” after receiving additional data about the shot.
“It is our job now to rigorously assess these data and the evidence submitted on the vaccine’s safety, quality and effectiveness,” said June Raine, chief executive of Britain’s Medicines and Healthcare products Regulatory Agency.
“As we have received this data through a rolling review, we have already started our analysis and will aim to make a decision in the shortest time possible, without compromising the thoroughness of our review.” (Reporting by Michael Holden; editing by Sarah Young)
Our Standards: The Thomson Reuters Trust Principles.
President Donald Trump’s 139th lawsuit may come at the hands of his arch-nemesis Governor Andrew Cuomo if he keeps the COVID-19 vaccine away from Black and Brown communities, in what proves to be a fitting end to a tumultuous four-year run.
As if we needed any more drama in 2020, Cuomo called out the president’s plan to deliver doses of the vaccine from Big Pharma producers like Johnson & Johnson, Moderna, and Pfizer to private pharmacies citing flaws in the White House Coronavirus Task Force’s distribution model.
Read More: Gov. Cuomo says ‘we spend too much time’ trying to interpret Trump
Historically these medication distribution models have not worked in favor of Black and Brown people because they rely too heavily on hospitals and big box store pharmacies rendering it less likely for low-income, uninsured, and marginalized communities to get the vaccine.
“Any plan that intentionally burdens communities of color to hinder access to the vaccine deprives those communities of equal protection under the law,” said Cuomo during a Sunday service at Riverside Church in New York City.
Cuomo went on to suggest that the Trump administration meet the people in the middle by including churches and community centers in its distribution plan.
I won’t hold my breath.
Read More: Trump COVID-19 official faces backlash for telling Michigan to ‘rise up’ against restrictions
Black people are no strangers to being shut out from medical care. The withholding of the syphilis-curing drug, penicillin, to 300 Black men during the infamous Tuskegee syphilis experiment serves as a constant reminder of this nation’s disregard for Black life.
While access to quality healthcare has improved for all people since 1932, when the experiment was first started, health disparities still remain. African Americans have the lowest life expectancy of any racial group – 75 years old compared to 79 years old for white people.
The dubious distinction of early death is based on differences in our social determinants of health, the factors that govern our health. These differences are due to structural racism; historical and contemporary policies aimed at disproportionately segregating communities of color from equal access and opportunity to quality education, jobs, housing, healthcare, and equal treatment in the criminal justice system.
Diseases like COVID-19 do not discriminate, but they do spread more rapidly among those discriminated against.
Eight out of 10 adult Filipinos believe that a vaccine and a medicine against the 2019 novel coronavirus disease (COVID-19) will be available in the next 12 months, the latest survey revealed.
The Social Weather Stations (SWS) said on Thursday night, Nov. 12, that its National Mobile Phone Survey conducted during Sept. 17 to 20 showed that “80% of adult Filipinos expect a vaccine against Covid-19 to be available in the next 12 months.”
The SWS noted that , among the 80 percent, 53 percent say it will probably happen, while, 27 percent believe it will definitely happen.
The same survey also found that “80% expect the availability of medicine for the effective treatment of Covid-19 in the next 12 months.”
They include 27 percent who believe that it will definitely happen and 53 percent who say that it will probably happen.
On the other hand, the SWS said 17 percent of adult Filipinos don’t expect a COVID-19 vaccine in 12 months.
Among those who don’t believe a vaccine will be released in 12 months, 12 percent say that it will probably not happen, while five percent believe it definitely will not happen.
Also, the SWS said the survey showed that 17 percent don’t expect a medicine for COVID-19 will be available in 12 months including 11 percent who say it will probably not happen and six percent who believe it will definitely not happen.
The latest SWS survey is “a probability-based survey conducted using mobile phone and computer-assisted telephone interviewing (CATI).”
There were 1,249 adult Filipinos, ages 18 years old and above, who participated in the nationwide survey.
They include 309 in Metro Manila, 328 in Balance Luzon, 300 in the Visayas, and 312 in Mindanao.
The SWS noted that the sampling error margin are ±3 percent for national percentages, ±6 percent for Metro Manila, ±5 percent for Balance Luzon, ±6 percent for the Visayas, and ±6 percent for Mindanao.
“The area estimates were weighted by the Philippine Statistics Authority medium-population projections for 2020 to obtain the national estimates,” the SWS said.
The SWS noted that the latest survey is non-commissioned and done on its own initiative and released as a public service.
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Eighty percent of adult Filipinos expect a vaccine and medicine for the coronavirus disease 2019 (COVID-19) to be rolled out in the next 12 months, a Social Weather Stations (SWS) survey has found.
In a non-commissioned poll conducted from September 17 to 20, the SWS asked 1,249 adult Filipinos whether they think a vaccine and medicine to treat COVID-19 will become available in the next 12 months.
80 percent of the respondents said they expect a vaccine to be rolled out in the next 12 months while 17 percent said they do not see it happening soon.
Similarly, 80 percent of those surveyed said a medicine to treat COVID-19 will likely become available in the next 12 months while 17 percent said they do not expect it to happen.
The proportion of Filipinos who expect a vaccine and treatment for COVID-19 to be out by next year was highest in Metro Manila at 85 percent, followed by Balance Luzon, Visayas, and Mindanao.
The expectations for the roll out of a COVID-19 vaccine and medicine are also significantly higher among more educated groups.
Eighty-one percent each of college graduates and high school graduates see a COVID-19 vaccine soon, compared to only 68 percent of non-elementary graduates.
Eighty-two percent of college graduates and 80 percent each of elementary and high school graduates expect a treatment for COVID-19 by next year, while only 70 percent expected the same among non-elementary graduates.
The expectations for a COVID-19 vaccine and medicine by 2021 were also higher among those aged 18 to 44 compared to those 45 years old and above.
Expectations did not vary significantly between men and women.
More Pinoys than Americans see COVID-19 vaccine by 2021
The SWS said its poll questions were patterned after an April-May survey conducted by the Pew Research Center in the United States.
The US poll found that 73 percent of Americans expect a COVID-19 vaccine in 2021, 26 percent do not see it happening, and 3 percent said it will definitely not happen.
However, there was hardly a difference in the number of Americans and Filipinos who said they expect a COVID-19 treatment to be out in the next 12 months.
The US survey found that 83 percent of Americans said a treatment for COVID-19 will likely be out next year, 16 percent do not expect the same to happen, and 2 percent said it will definitely not happen soon.
Vaccine czar Secretary Carlito Galvez Jr. earlier said the bulk of COVID-19 vaccines will likely become available in the Philippines in the end of 2021 or early 2022. —LDF, GMA News
This article SWS: 80% of Pinoys expect COVID-19 vaccine, medicine by 2021 was originally published in GMA News Online.
COVID-19 vaccine: Penn Medicine researcher Dr. Drew Weissman laid groundwork for Pfizer, Moderna vaccines
“That’s the highest number I have seen for a respiratory vaccine in humans,” said Dr. Drew Weissman from the University of Pennsylvania.
He is pleasantly surprised with Pfizer’s reported 90% efficacy with its experimental coronavirus vaccine. After all, he helped develop the technology for the vaccine.
It’s called messenger RNA or mRNA.
“What’s different about mRNA is it’s a genetic vaccine,” he said.
Other vaccines, such as the flu shot, use live or inactivated virus to create an immune response, but mRNA tricks the body into mounting it’s own defense.
The vaccine made by Moderna is similar and also uses mRNA. Because of that, Dr. Weissman expects similar efficacy.
What’s still unknown is how long immunity from the vaccine would last.
“What we do know is in our animal studies, the antibody responses last a long time. We’ve gone years and antibody response hasn’t dropped in monkeys, so I have high hopes durability will be very good,” he said.
He also hopes enough people choose to get vaccinated to make a difference.
“If they do, the pandemic will be over in a year or so, if they don’t know what’s going to happen,” he said.
Dr. Weissman says when the choice is getting a safe vaccine or getting sick with COVID-19 or passing it on, the decision should be clear.
Dr. Weissman was also a fellow at Dr. Anthony Fauci’s lab years ago.
Copyright © 2020 WPVI-TV. All Rights Reserved.Read More
Prepared by Tara, Senior Analyst at BAD BEAT Investing
Planet Fitness (NYSE:PLNT) is a stock we have traded several times. We took solid profits back in 2018 and has been just trading it here and there ever since. We had another trade on in H2 2019 that worked out. Back in August, we called for a buy in the mid $50s as we believed the stock would catch a reopening bid later in 2020. In fact, we said “the bottom is in.” That drew the ire of bears on our contrarian call, but alas, the proof is in the print. Our main thesis in August has now occurred/is playing out, with great positive news on a vaccine. PLNT stock was a huge beneficiary.
Our members who bought this stock and were patient for a few weeks saw rapid returns. While we cannot blame anyone for locking in profits here being up 40% on the trade following our guidance, there may be more room to run. There may be a profit-taking wave first, but we think the market continues to assign a reopening premium. The market has had some good news in potential treatments/vaccines, but more importantly, gyms are being allowed to reopen in most areas, including New York State which was ravaged by COVID-19 and saw some of the most stringent rules put into place.
We think PLNT stock gets a boost from this news. While COVID-19 will get worse before it gets better, it looks like the tides are turning in the war against this scourge. COVID-19 has hit the company hard as evidenced by the recently reported earnings, and it shows the severe impact of COVID-19. Bottom line here is that things will improve into 2021, and the market is likely to price the stock accordingly. Let us discuss the play we think you can make and the story here longer term.
Top line contraction continues
The just-reported Q3 saw revenues contract significantly once again following pain in Q1 and Q2. It was tough to handicap the quarter, but let’s be real, the shutdowns hurt, although the situation was improving. We saw Q3 revenues coming in down by as much as 40% to $101 to $106 million, based on membership dues freezes across all stores, equipment sales reductions, and national advertising fund revenue. It was bad. Revenues fell 37% year-over-year.
Revenues fell to $105.4 million and came in actually at the higher side of our estimates. The Street saw a consensus figure that was more liberal than ours. Their consensus was missed by $3.6 million. Normally, we look at growth metrics like same-store sales growth and new gym openings, but in this case, those metrics are not as relevant yet given so many were closed and just starting to reopen. That said, system-wide same-store sales decreased 5.6%. The good news is that by the end of the quarter, 95% of locations were open. This sets up Q4 nicely and especially 2021.
New gyms were certainly driving growth in