Finally, the End is Near!!!
I am not talking about THE end of the world but an end to our struggles with the deadly COVID-19 pandemic.
Because, the COVID-19 Vaccine is on its way to us (And I mean literally, it is on the way as we are talking).
According to an NDTV post on 12 January 2021, the first batch of the Covishield vaccine, a version of the Oxford-AstraZeneca’s vaccine that is being manufactured by the Serum Institute of India, has left for Delhi and 12 other cities of the country.
And all of this preparation is for the
World biggest inoculation drive, India’s Covid-19 vaccination drive, which is to be held on 16 January 2021, as Tweeted by the Hon’ble Prime Minister himself.
I know that you all must have hundreds of questions regarding the vaccine and are really curious about this drive.
And must be wondering what the vaccines that are going to be used are? How will it be given to people? And who will receive the vaccine first and what’s the process?
But, Don’t worry!!!
All of these questions along with the others will be covered in this blog.
Read more to find everything about the Vaccines for COVID-19:
What are the Vaccines that are going to be used in the COVID-19 Vaccination Drive?
You all must have known that in the last year 2020, the whole research facilities and manufacturing companies around the world were trying to create the Vaccine.
And after numerous attempts, they have succeeded.
Because now, there are a broad range of COVID-19 vaccines candidates that are being investigated globally using various technologies and platforms.
Some of them are in the clinical trials, others are at initial stages. But, there are a few that have passed the final clinical trial stage and are ready to enter the market.
On the 16 January Vaccination drive, these 2 vaccines will be used:
Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV), Covaxin is India’s indigenous COVID-19 vaccine.
Covaxin uses inactivated’ or ‘dead’ coronavirus, which triggers an immune response when entered the body.
So, if faced with a similar virus in future, then the body will fight it back.
Manufactured by Serum Institute of India, Covishield is a version of the Oxford-AstraZeneca’s vaccine.
And when the vaccine is injected into the human body, a spike protein of SARS-CoV-2 coronavirus is inserted into ChAd0x virus.
So, as soon as the human body cell recognizes the spike protein, it triggers an immunological reaction against the virus.
These vaccines will be given in two doses that will be 28 days apart. And both the doses have to be taken in order to complete the vaccination schedule.
The vaccine will be given at fixed venues that will be medical centres, hospitals, along with schools and community halls.
Who will be given the Vaccine first?
The Vaccination process of the COVID-19 vaccine is divided into 2 phases, the first and second phase.
First Phase of the Vaccination Drive:
In the first phase of the vaccination, around 3 crore healthcare and frontline workers, from both the private and government sectors, will be vaccinated using the 2 vaccines.
The frontline workers include police and paramilitary personnel, sanitation workers, home guards, and disaster management volunteers.
Also receiving the vaccination in the first phase will be civil defence and revenue officials associated with containment and surveillance.
Hon’ble Prime Minister Narendra Modi has assured that 3 crore healthcare and frontline workers will receive the COVID-19 vaccine free of cost and that the state governments will not have to bear the financial burden of it.
Second Phase of the Vaccination Drive:
Then the second phase of the vaccination drive will cover nearly 27 crore people, making it the world’s largest COVID-19 inoculation drive.
People above 60 and those between 50 and 60 years of age groups with co-morbidities will be given the vaccine in the second phase.
After the completion of the priority vaccination, the rest of the population will be vaccinated in a staggered manner.
What will be the Vaccination Process?
People who are eligible for the first phase of the vaccination will be informed through their registered mobile number.
The information about the health facility where the vaccine will be provided and the health schedule will be sent to them.
On the appointed date, people who are registered will be given the vaccine.
To check for any adverse effects, vaccinated individuals will be kept under observation by a five-member vaccination team, for 30 minutes.
Two weeks after the second dose, protective levels of the antibodies against the virus will develop.
It is important to ensure that both doses of the vaccination should be completed with a single type of vaccine, as different Covid-19 vaccines are not interchangeable.
Will the Vaccine interferes with the medication for cancer, diabetes, and hypertension, etc.?
The medication will not affect vaccine efficacy.
People with one or more co-morbid conditions are at a higher risk of getting infected. Therefore, they should take the vaccine.
Also, people who have recovered from the COVID-19 infection should also take the complete schedule of the vaccine, as it helps develop a better immune response against the disease.
Hope this vaccination drive becomes a successful event and the vaccine works efficiently in combating the deadly coronavirus.
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Stay Safe, Stay Healthy…
The post New COVID vaccines could revolutionize vaccination appeared first on Healthy Debate.
“There’s a long list of things we don’t know,” says Maria Sundaram, a postdoctoral fellow at the Centre for Vaccine Preventable Diseases at the University of Toronto. Health Canada is currently reviewing early findings from Moderna, Pfizer/BioNTech and, more recently, the University of Oxford/AstraZeneca. All three show promise, but not have shared their full data, instead issuing a series of press releases.
The biggest unknowns are whether these results will hold up once full study findings are published and if a similar level of protection can be expected for other COVID-19 vaccines coming down the pipeline. The results could also change once these vaccines are rolled out on a population scale. We know that these vaccines work in clinical trials but we won’t know if their effectiveness will be the same in real-world scenarios.
“There’s no way that we can see that without a vaccine being licenced,” said Sundaram.
Although the trials included a diverse group of participants, including older adults and those from racial-ethnic minorities, it’s hard to know whether these findings will be generalizable to a broad range of people once the vaccines become available, experts say. For example, there is no information about how well this vaccine works in children. All three trials reported early results only in adults over the age of 18.
In addition, we don’t know if the vaccines prevent asymptomatic transmission.
“That’s something that is often an issue when designing vaccines for respiratory viruses that are administered intramuscularly,” according to Alyson Kelvin, a virologist with the Canadian Centre for Vaccinology at Dalhousie University who has recently been seconded to work on COVID-19 vaccines. “When we give a vaccine in your arm, it’s often hard to get mucosal immunity in the upper respiratory tract,” like your nose, which is needed to stop transmission. A key for effective policy, she says, will be knowing whether someone who is vaccinated is still able to transmit the virus.
Also unknown is how well the vaccines will work in people who have already had COVID-19. All three studies excluded people with prior COVID-19 infection, although Pfizer/BioNTech and Oxford/AstraZeneca plan to look at this in a separate analysis.
As with all new vaccines, the length of protection has yet to be determined, since all three trials only began enrolling participants this summer. The companies have not disclosed how long participants were observed or whether any violated the study rules, which could change the initial efficacy estimates.
“Right now, we only have the interim data,” said Kelvin. We won’t know their long-term safety profile or whether they might cause rare side effects until after the vaccines are deployed to the public, although no safety issues have been identified to date.
“They seem to have a really positive safety profile. I haven’t seen anything that I am initially concerned with,” says Kelvin.
Protection could also be lower if people don’t adhere to the vaccine schedule. All three vaccines require two doses spaced at least three or four weeks apart.
“I think one really important question is: are people going to come back in for a second dose?” asks Sundaram. She says this might be an issue particularly if the first dose causes adverse reactions like a headache or fever.
Vaccine side effects may make people more hesitant to get vaccinated in the first place. In a StatsCan survey conducted before the recent vaccine announcements, about one in seven Canadians said they were unlikely to get a COVID-19 vaccine, citing a lack of confidence in safety and concerns about its side effects.
What about other COVID-19 vaccines in development?
All three vaccines reporting early results use newer technologies that deliver genetic material from the SARS-CoV-2 virus – either alone through what’s call messenger RNA (or mRNA, used by Pfizer/BioNTech and Moderna) or contained inside another virus or “vector” that can’t replicate on its own (Oxford/AstraZeneca). They then hijack the body’s own cells to make copies of the viral spike protein, the crown-like molecule protruding from the surface of the SARS-CoV-2 virus.
These types of vaccines have never been licenced before for use in humans.
Nine other COVID-19 vaccines are currently in late-stage trials, including four that rely on more conventional vaccine models using an inactivated (or killed) virus. These vaccines may elicit a more robust immune response that targets other viral components, not just the spike protein. They also may be better tolerated than some of the mRNA or viral vector vaccines based on earlier trial results.
Four are non-replicating viral vectors like the Oxford/AstraZeneca vaccine. These types of vaccines could have lower vaccine efficacy if people have pre-existing immunity to the vector. (Oxford/AstraZeneca tries to get around this by using a chimpanzee adenovirus, rather than a human one, as their vector.)
Others, like Novavax’s protein subunit vaccine, may be better able to generate a protective antibody response in the upper respiratory tract, which is important for blocking transmission, says Kelvin, whose lab is also developing a COVID-19 subunit vaccine.
Because they use different ways to trick the body’s immune system to produce antibodies, scientists can’t say whether these vaccines will be able to replicate the 90 to 95 per cent efficacy seen in the early trials.
“I don’t know what to expect. I’ll be honest with you,” states Sundaram. “I think it’s hard to use the results from these (three) studies to extrapolate to the other ones, especially for the other vaccine types.”
The number of doses, vaccination schedules and route of administration could also affect vaccine efficacy – along with patient factors such as age, underlying conditions and pre-existing immunity and viral factors such as genetic mutation. Experts say the latter is of less concern since SARS-CoV-2 doesn’t mutate as much as other RNA viruses, like influenza.
While much remains unknown about these vaccines, these early results exceed the expectations of most scientists and bode well for other COVID-19 vaccines in development. Recently, Health Canada announced it would license a COVID-19 vaccine if it met a threshold of at least 50-per-cent efficacy.
The true impact of these new COVID-19 vaccines on curbing the pandemic will depend both on their efficacy but also their uptake on a population scale.
Given potential delays in vaccine manufacturing and rollout, a COVID-19 vaccine will likely not be enough to end the pandemic. But it will be another tool in our public health toolbox, alongside physical distancing, contact tracing and community supports, says Sundaram.
“As always, there’s more work to be done and further questions to be asked in Phase 4 studies,” says Sundaram. “But this is exactly the sort of direction that we would have hoped things would go. So, I’m very happy about that.”
- The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020
- The submitted data showed a 95% efficacy rate, efficacy was consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults aged ≥65yrs. of >94%, favorable tolerability with no safety concerns
- In addition to submission to EMA, FDA & MHRA, the companies have also initiated additional rolling submissions across the globe including in Australia, Canada, and Japan, and plan to submit applications to other regulatory agencies globally
Click here to read full press release/ article | Ref: Globe Newswire | Image: Stat
The post BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19 first appeared on PharmaShots.
- The companies initiated the P-II study of their COVID-19 vaccine in China. The trial will generate data to support the BLA filing for approval of the vaccine in China
- The study will be conducted by Jiangsu Provincial Center for Disease Control and Prevention. The study will commence with the recruitment of 960 patients aged b/w 18-85yrs.
- In an ongoing P-III study, it met all 1EPs with an 95% efficacy rate in preventing symptomatic COVID-19 infection. The data supports the submission of an EUA to the US FDA on Nov 20, 2020
Click here to read full press release/ article | Ref: BioNTech | Image: World Pharma Day
The post BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China first appeared on PharmaShots.
2020 has been an awful year. Hurricanes, wildfires, murder hornets, unjustified shootings, a divisive Presidential election, and, of course, a pandemic. Most of us are spending unprecedented amounts of time sheltering in place, millions have lost their jobs, the economy is sputtering, and over a quarter million of us didn’t survive to Thanksgiving. If you haven’t been depressed at some point, you haven’t been paying enough attention.
Within the last two weeks, though, there has finally been some cause for hope. Whether you want to credit Operation Warp Speed or just science doing what it does, we are on the cusp of having vaccines to battle COVID-19. First Pfizer/BioNTech, then Moderna, and most recently, AstraZenica, announced vaccines that appear to be highly effective.
We’re having our Paul Revere moment, only this time with good news. The vaccines are coming! The vaccines are coming!
It strikes me, though, that our enthusiasm about these vaccines says a lot about why the U.S. has had such a hard time with the pandemic; indeed, it tells us a lot about why our healthcare system is in the state it is. We’re suckers for the quick fix, the medical intervention that will bring us health.
Unless you were alive when Woodrow Wilson was President, COVID-19 has been the worst public health crisis of our lifetime. It took some time for us to fully realize how bad it was going to be, and, even then, most of us underestimated exactly how bad that would be. We may still be underestimating how bad these next few months will be.
We knew, of course, that we didn’t have any vaccine for this new virus, and that, at best, it would take some time to develop one. We didn’t initially know what to expect when someone became infected, didn’t know the right treatments, didn’t know which therapeutics might help. We weren’t even really sure how COVID-19 spread. There have been many hard-won lessons.
What we did know, though, was that we needed to take precautions. Physical distancing, limiting social gatherings, wearing masks, contact tracing; we knew these things would help. They wouldn’t prevent COVID-19 from spreading, they certainly wouldn’t cure it once infected, but they would mitigate.
We couldn’t even do those right.
Mask wearing became a political issue. It is not a coincidence that some of the areas with the lowest percent of people wearing masks are among the hottest spots for spread of COVID-19, such as North Dakota, which has the highest COVID-10 death rate in the world right now.
While overall mask wearing has improved from the spring, to the point as many as 90% of Americans claim they usually wear a mask in public, it varies widely, as illustrated below:
Similarly, business shutdowns and stay-at-home orders have faced great resistance, again more along political lines than to intensity of COVID-19 cases. There are no doubt grave economic impacts to them, as we’ve seen, but whatever such measures we tried in the spring are now seen as a price we are no longer willing to pay.
Of course, if we had quicker and more widespread testing, and better contact tracing, we might not need such extreme measures, but we’re not very good at them. We don’t have enough tests, they take too long for accurate results, and a sizeable number of Americans view contact tracing with suspicion.
The CDC pleaded with us to celebrate Thanksgiving at home with only the people we live with. Do we listen? Of course not; nearly 40% of us plan to attend large gatherings. Over a million Americans flocked to the airport yesterday – the highest daily number since mid-March – with millions more expected to travel between now and Thanksgiving. That is admittedly down from previous years, but at a time we are regularly breaking daily records for cases, hospitalizations, and deaths, it seems rather foolhardy.
Why should we worry? There’s a vaccine coming.
Of course, no vaccine has yet been approved, none is in full production, there are tremendous production and logistical issues to overcome. It will take many months to have enough supply to vaccinate enough people to make an impact on COVID-19’s spread.
Equally troubling, experts estimate that, even with a vaccine that is over 90% effective, over 70% of people have to get vaccinated. That may be a problem; fewer than 60% of Americans say that would be willing – and that’s up from earlier in the year. Even healthcare workers, who are expected to be first in line when vaccines become available, are not yet convinced they’ll take it.
There may be a light at the end of this particular tunnel, but it’s a long tunnel.
We’ve all got pandemic fatigue, we all want COVID-19 gone, we all want to go back to our “normal lives,” but we don’t seem quite able to bring ourselves to do the things we should in order to help bring those about. Somehow, we assume, doctors and scientists will fix things for us. It’s par for the course.
We don’t do enough about our diet and exercise; it’s easier to just take pills for our high blood pressure and bad cholesterol. We don’t eat enough fruits and vegetables, so we take supplements to get the necessary vitamins and minerals. We don’t stay active enough, so we end up with hip and knee replacements. We claim to worry about the safety of vaccines, but give processed food manufacturers carte blanche to tailor their products to maximize our consumption.
We debate the need for universal coverage, but don’t spend nearly enough time talking about food or housing insecurity. We not only can’t persuade ourselves to take climate change seriously, we don’t even care to ensure that our water and atmosphere are safe now.
It’s easier to trust health care to protect our health than to take responsibility ourselves, even though medical care is estimated to only account for 10-20% of our health. So why wear a mask? Why social distance? Why stay in our family bubble? Soon there will be a vaccine. We need to stop acting like the proverbial damsel in distress waiting to be rescued, and start taking more responsibility for our own health – for COVID-19 and all the health issues we face.
Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor.
With the emergence of two vaccines with high levels of effectiveness, there’s a strong prospect of having powerful new tools to combat Covid-19 in the months ahead. But the road between a vaccine and society returning to normal is far from certain. Millions of doses will need to be produced and intelligently distributed, and critically, people must be willing to take them. The last few months have seen already-low confidence in such a vaccine fall even further, with just two-thirds of Americans expressing a willingness to be vaccinated when one becomes available. Similar trends are playing out globally.
Bringing the pandemic under control will likely require successfully vaccinating 60–70% of the population to halt community transmission. Vaccine skepticism puts rapidly reaching that goal in jeopardy. Can the government at the state or federal level mandate vaccination? What is motivating this growing skepticism in Covid vaccination and how might those sentiments shift over time? This week, Phillip looked at 28 articles from 24 sources to explore likely pathways toward vaccination, as well as related vaccine skepticism.
Growing Vaccination Skepticism
A big surprise of the last few months has been that skepticism of a Covid-19 vaccine has intensified even while the virus has become increasingly worse — netting 1 million new cases in a single week and bringing the U.S. death toll to above 250,000. This shift in opinion is problematic for pursuing effective vaccination and is not specific to the U.S. All but three countries monitored in an Ipsos-MORI poll in October found that willingness to take a Covid-19 vaccine had fallen since the previous poll in August, bringing the worldwide average down from 77% to 73%. The U.S., with roughly 65% willing to vaccinate, scores similarly with some other countries such as Spain and Italy that have been hard-hit by the pandemic, while France, an outlier, scored just 54%.
Given the grim conditions, declining trust in a Covid-19 vaccine may be intuitively surprising, and most see this pushback as a general skepticism about the speed with which Covid-19 vaccines are being pursued, not growth of the anti-vaccination movement. Through inherent complexity and novelty but also human error, the pandemic has created no shortage of uncertainty and misinformation, which has at times reflected poorly on government authorities and at others provided fuel to those that want to cast doubt on both scientific and governmental authority.
No wonder then that people globally are equally worried about potential side-effects (34%) and the fast pace of clinical trials (33%). In the U.S. in particular, the public has expressed concern about undue political pressure from the Trump administration to approve a vaccine, particularly given the Food and Drug Administration’s mixed record on resisting such pressure. The two vaccines that have emerged, from Pfizer/BioNTech and Moderna, have passed phase 3 trials with 43,000 and 30,000 participants, respectively. Fully analyzing the efficacy of either vaccine, including their potential side effects, which at this point look minimal, will have to wait for the release of full clinical data. It’s important to note that vaccines in recent history have an excellent track record in terms of safety and that early signs suggest these vaccines will be safe.
In the weeks and months that it might take for either to reach the public, much work remains to be done to address this skepticism. Even if these vaccines swiftly receive approval and are rapidly produced in the quantities needed, effective vaccination will depend on enough of the population taking part, leaving many to speculate about whether the government has a right to force specific populations to vaccinate and whether it will need to exercise such a power.
Pathways to Vaccination
Vaccine believers and skeptics alike are interested in the same question: can the government force people to take vaccines? In the U.S., matters of public health are generally in the purview of state governments, and historic precedent shows that states are within their rights to enact vaccine mandates within their jurisdictions. The federal government, by contrast, would have a much more difficult time enacting such a mandate, though they and the private sector could use a variety of incentives encourage widespread vaccination.
The legal precedent for vaccination mandates at the state level is laid out by a Supreme Court case from 1905, Jacobson v Massachusetts, which confirmed a state’s right to enact “reasonable regulations established by legislature to protect public health and safety.” In addressing an outbreak of smallpox in Massachusetts, this case clarified that such an order is not a violation of the 14th Amendment right to liberty, but rather that liberty could not exist if individuals could act in a way that is injurious to others, for example, by carrying a disease that could otherwise be vaccinated against. In determining if an action such as vaccination is helpful or harmful to public health, the state has a right to refer to a board of qualified individuals to make such an assessment. Furthermore, “it is immaterial whether or not the vaccine is actually effective, so long as it is the belief of state authorities that the mandatory vaccine will promote common welfare and is a reasonable and proper exercise of the police power.”
“While compulsory vaccination requirements have faced legal challenges since Jacobsen . . . courts have consistently rejected these challenges and given considerable deference to the use of the states’ police power to require immunizations to protect the public health.” – Congressional Research Service
This precedent has held since 1905, having most recently been the basis for mandatory vaccinations in several zip codes in New York City following a measles outbreak in 2019. But states don’t just exercise this power in times of major disease outbreaks — there are mandatory vaccinations for K-12 schoolchildren in all 50 states, as well as mandatory vaccinations for many college students and individuals that work in healthcare facilities and nursing homes. While some religious and philosophical exemptions exist, states like California and New York have ended these, citing that “religious exemptions are not constitutionally required under the First Amendment’s free exercise clause since mandatory vaccination does not single out religion and is not motivated by a desire to interfere with religion.”
In short, states almost certainly have the ability to force vaccinations within their jurisdictions and weather any legal challenges, though this doesn’t necessarily mean they will seek to do so.
The federal government would face more challenges if it wanted to mandate vaccinations for Americans, chiefly because the Constitution leaves the right to govern public health to states. But this hasn’t stopped people from musing about how, if the pandemic required, the federal government might press the issue. The federal government could, for example, take advantage of its right to regulate interstate commerce and transportation to mandate that individuals crossing state borders are vaccinated, though the Supreme Court could potentially rule that Congress was overreaching by doing so. Realistically, such a strategy seems doubtful given the legal constraints, but unprecedented times may call for unprecedented measures.
Far more likely, the federal government might exercise influence over spending in a way to incentivize states to pursue vaccination mandates. The federal government has expansive control in taxing and spending for general welfare, meaning they could tie funds distributed to states to adherence to vaccination goals. This strategy has been used in the past, such as to force states to raise the legal drinking age to 21 by withholding federal highway funding.
So, while federal measures to force vaccination seem improbable at present, they are not out of the question. In a similar vein, as many countries enact nationwide mask mandates, such a move in the U.S. would almost certainly face a strong legal challenge. This leads many to favor a strategy focused on persuasion and incentivization rather than punitive action.
As with most issues of governance, there are those that favor a hands-off approach, letting the private market and personal discretion decide what’s right. The thinking here is that government mandates would be overkill, especially when businesses have rights and incentives to demand that customers vaccinate, as long as these measures are not discriminatory. As put in the Wall Street Journal, “[p]rivate entities have financial and reputational incentives to protect their employees, patrons and residents, and are therefore well-positioned to determine what protective measures, including vaccination, need to be taken in specific circumstances.” Furthermore, some argue that government action invites a higher risk of inefficiency by distorting the vaccine marketplace for personal, country-specific benefits.
“Private initiatives creating narrow mandates that target those most likely to benefit from vaccines, alongside voluntary vaccination, will maximize public health while minimizing the threat to individual liberties.” – Wall Street Journal
Instead, proponents of the free market argue that positive incentives might be more effective. If someone wants to attend a sporting event, the venue may require proof of vaccination to protect against liability. Similarly, those who wish to travel by air may be forced by airlines to have a vaccination certificate or similar documentation. At a more granular level, however, this method would require many smaller businesses to follow through as well. The risk is that too few entities comply or that pockets or communities of people disproportionately skirt the needs for such action, permitting Covid-19 transmission to continue and potentially re-emerge.
As governments assess how to contend with reaching effective levels of vaccination, they are preparing to tread carefully around vaccine skepticism while transparently and apolitically addressing common concerns about safety and due process. Attitudes could change as vaccines are distributed to the public and, hopefully, demonstrate safety and effectiveness, encouraging individuals to rapidly vaccinate.
For government, a heavy-handed approach could backfire, fueling further anti-government/anti-science sentiment, but not pursuing vaccination with ample vigor could mean a prolonged timeline for controlling the virus and returning to normal, raising human and economic costs. That’s why the likely approach to vaccination will lie in some combination of policies: using mandates only were strategically viable and necessary but relying on public and private incentives to reach most of the population.
This appendix shows each of the articles used to inform the findings of this article, as well as how the articles scored according to The Factual’s credibility algorithm. To learn more, read our How It Works page.
Phillip Meylan is an Adjunct Fellow @ the Center for Strategic and International Studies and Political Analyst @ The Factual where this piece was first published.
- J&J and the US Department of Health and Human Services have expanded an agreement to support the next phase of COVID-19 vaccine candidate research and development
- Janssen will commit ~$604M while BARDA will commit ~$454M to support the ongoing P-lll ENSEMBLE study assessing Janssen’s JNJ-78436735 as a single-dose in ~60,000 patients globally
- J&J affirmed its commitment to develop and test its vaccine candidate in accordance with high ethical standards and sound scientific principles, as outlined in a pledge made by 9 vaccine manufacturers in early 2020
Click here to read full press release/ article | Ref: PR Newswire | Image: Courier Journal
The post J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development first appeared on PharmaShots.
- Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community
- The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
- NVX-CoV2373 is evaluated in P-ll trial in the UK and 2 ongoing P-ll studies that began in Aug’2020, a P-llb trial in SA, and a P-l/ll continuation in the US and Australia. Additionally, Novavax has multiple agreements for the supply of NVX-CoV2373 directly to the US, UK, Canada, and through partnerships, supply to Japan, South Korea, and India
Click here to read the full press release/ article | Ref: GlobeNewswire | Image: MediCircle
The post Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19 first appeared on PharmaShots.
- CEPI’s total investment in Clover’s S-Trimer vaccine candidate will be up to $328 M, including $69.5M previously announced have funded preclinical studies and P-l study, preparations for the global pivotal P-ll/lll efficacy study, and initial manufacturing scale-up activities
- The expanded collaboration will provide $258.5M for a global pivotal P-ll/lll efficacy clinical trial which is expected to begin before the end of 2020 and generates the safety and efficacy data to support licensure of the vaccine candidate in China and across the globe
- The collaboration anticipates that the vaccine will be made available for procurement and allocation through the COVAX Facility, which aims to fairly distribute 2B doses of COVID-19 vaccine by the end of 2021
Click here to read the full press release/ article | Ref: Businesswire | Image: Los Angeles Times
The post CEPI to Invest ~8M in Clover’s COVID-19 Vaccine Candidate first appeared on PharmaShots.
Is a century-old vaccine a ‘game-changer’ for COVID-19? Anita de Waard from Elsevier and Radoslav Kirkov from Estafet tells us how a hackathon is harnessing data science to look beyond the hype and seek definitive clinical evidence.
Today, the notion of ‘data science’ has permeated almost every area of society. Words like machine learning, artificial intelligence and deep learning have entered the everyday business lexicon. From government agencies to online retailers, a ‘big data strategy’ is a must-have. This year, as the COVID-19 pandemic has spread, there has been increased talk of statistics, modelling, predictive analytics, and using data to solve the serious issues we face.
But often, what purports to be data science is actually just a random correlation between different data sets. The phrase ‘data science’ is often used to represent any form of data analysis, however rudimentary, and regardless of whether it is based on scientific understanding. Given the amount of faith we increasingly put in algorithms to make decisions on our behalf, whether in our hospitals, our courts, or our education system, we need a much deeper understanding of how these correlations are drawn, and what they are based on, in order to apply data science for good.
This is especially true in the search for effective therapies to fight COVID-19, and a vaccine. Speed is truly of the essence, but at the same time, the integrity of the science underpinning any clinical recommendations must be maintained. With so many research projects, collaborations and clinical trials taking place in an attempt to limit and prevent the virus, we have to be clear on how decisions are being made and what the data behind an apparent breakthrough is really telling us.
Understanding the link between COVID-19 and the BCG vaccine
A good example of this phenomenon is the sudden hype around the Bacillus Calmette–Guérin (BCG) vaccine, which is primarily used against tuberculosis (TB). This century-old vaccine came to prominence recently, when a number of early ecological studies (those which study population factors in epidemiology) seemed to show a strong correlation between receiving the vaccine and having immunity against COVID-19.
Some studies suggested the link was a “game-changer” and a “silver bullet”. The studies claimed to show a strong correlation between the BCG vaccination and protection against COVID-19, but closer examination revealed a tenuous correlation, from which clear conclusions can’t be drawn. Indeed, the World Health Organization said that, “Such ecological studies are prone to significant bias from many confounders, including differences in national demographics and disease burden, testing rates for COVID-19 virus infections, and the stage of the pandemic in each country.”
The world-leading TB researcher Prof. Madhukar Pai was also quick to warn of the serious limitations with this approach and the need to be cognizant of confounding variables. In a worst-case scenario, misplaced hype could lead to a sudden rush to buy doses of the BCG vaccine. For developed nations with low TB rates, this would have little impact. But in nations where TB is more widespread, such as India, the potential implications of a sudden shortage of BCG vaccine could put many lives at stake.
The aim now must be on providing stronger clinical trial evidence of the link between the BCG vaccination and incidence of COVID-19, to enable data-led decisions to be made. There are clear shortcomings with current ecological studies, which take aggregated data and look to make inferences at an individual level. If the data are not representative or confounders are not taken into account, the results will be inaccurate.
Establishing an evidence-backed link
The only way to truly understand the correlation between COVID-19 and the BCG vaccine is to conduct randomised trials combined with deep analysis of existing data. To that end, Estafet and Elsevier have initiated a two-stage hackathon. The groups are working together with the BCG World Atlas team, which is led by an infectious disease specialist at the University of Ottawa, Dr Alice Zwerling. The BCG Atlas is an open-source database of global BCG vaccination policies and practices, founded in 2011.
Many of the aforementioned ecological studies were based on data from the BCG Atlas, so the first stage of the hackathon aimed to augment and improve the Atlas; with additional data and health records available on BCG vaccinations. These have been found through natural language processing (NLP) methods. With thirty volunteers globally, including judges, organisers, and data gatherers, prizes were awarded to those deemed to have extended the data most. The winner was Dimitrina Zlatkova of Sofia University, who contributed 57 additional data points, followed by developer Marouane Benmeida of Morocco who added 33 additional data points.
The hackathon now moves to stage two, where the volunteers will seek to answer a series of questions, such as whether the BCG vaccination is causally related to reduced COVID‐19 mortality, or if other factors like lockdowns and average age of the population are responsible for the different mortality rates. If the BCG vaccination does reduce COVID-19 mortality, what are the key factors. For example. how long does the immunity from BCG last after that vaccination? Does the strain of BCG vaccination impact immunity? The team is now looking for more volunteers to get involved as the hackathon progresses. Once complete this most valuable insights from the task will be shared with the ongoing BCG COVID-19 clinical trials.
Data science for good
When it comes to COVID-19, data science will certainly be critical – but it is the blend of scientific understanding and technical acumen through data science that is vital.
It is a job for all of us engaged in data science projects – whether in academia or commercial or government research – to stem the hype. It is important to assess the veracity of a claim before accepting any conclusions, and empower the public to do the same. This habit of mind is important not only in the development of treatments and vaccinations, but paramount to establishing a broad public trust in data-led decision making.
About the authors
Anita de Waard is VP research collaborations at Elsevier and Radoslav Kirkov is technology director at Estafet.
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- The P-I/II study of AZD1222 has resumed in Japan following the discussion with the PMDA. Additionally, the company is in talks with the US FDA to facilitate review of the information needed to decide regarding the resumption of the US trial
- A standard review process triggered a voluntary pause to vaccination across all global trials on Sept 06, 2020, to allow the review of safety data by an independent committee
- The resumption follows the restart of clinical study in the UK, Brazil, South Africa, and India
Click here to read full press release/ article | Ref: AstraZeneca | Image: Mint
Related News: AstraZeneca Resumes COVID-19 Vaccine Trials in the UK
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The Hague — Governments and other stakeholders must take urgent action to ensure equity in access to disease prevention measures, which includes greater investment in vaccines and vaccination services by community pharmacists. So said the International Pharmaceutical Federation (FIP) in a call to action made today at the start of a new FIP Digital Programme to
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- BioNTech and Fosun collaborated to supply 10M doses of their BNT162 mRNA-based vaccine candidate against COVID-19 to Hong Kong SAR and Macao SAR, once approved
- Fosun Pharma has signed the Letter of Intent with Jacobson for contemplated distribution of 10M doses of a vaccine targeting COVID-19 in the Chinese market
- On Mar 13, 2020, the companies collaborated to jointly develop and commercialize the vaccine in Mainland China, Hong Kong, and Macau SAR and the Taiwan region. The P-I study of BNT162b1 has been initiated in China and enrolled 144 participants
Click here to read full press release/ article | Ref: BioNTech | Image: StraitTimes
Moderna has said that its coronavirus vaccine stimulated an immune response in older people in phase 1 trials, suggesting that the jab is effective in the age groups most susceptible to COVID-19.
An analysis of the latest data from a phase 1 trial showed that in 20 older adults given the vaccine – ten between the ages of 56 and 70 and ten aged 71 and older – the vaccine produced neutralising antibodies and T-cells in comparable levels to those aged 18 to 55-years-old.
These antibody levels were also higher than those typically seen in people recovering from the virus, the company said.
There were also no serious adverse events reported. Some patients reported fatigue, chills, headaches and pain at the injection site, though the majority of symptoms resolved within two days.
Each participant received two 100 microgram doses of the vaccine 28 days apart – the same dose used in the vaccine’s ongoing phase 3 trials.
Moderna said the results show that the vaccine works as well in older adults as it does in people aged 18 to 55-years-old.
Death rates from COVID-19 are much higher in older people, but often people in these age groups show smaller immune responses from vaccines than younger adults.
The company’s shares rose about 6% on the news.
Health officials had previously expressed concerns that Moderna’s phase 1 study was small and that results may differ for other populations, including older people. This analysis may allay those concerns.
The company has also noted that 18% of the participants enrolled in its phase 3 study are Black, Latino, Native American or Alaska Native – groups that are often underrepresented in clinical studies but have been hard-hit by COVID-19.
Moderna has received funding from the US government to expand its late-stage trial. The US has also bought 100 million doses of the mRNA vaccine for more than $1.5 billion – a deal that sparked controversy when the consumer advocacy group Public Citizen said that taxpayers were “paying twice” for the jab.
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Edinburgh-based biotech company Ingenza Ltd. has made a significant breakthrough in the race to develop and manufacture a cost-effective vaccine against SARS-CoV-2, the virus responsible for the current COVID-19 pandemic. Ingenza has been working closely with researchers at Oxford University and the UK CPI, Wilton, since the start of the outbreak, and the collaboration is
- For smaller volume agreements, the company has priced its COVID-19 vaccine ranging from $32-$37/ dose, higher than the price of Pfizer’s vaccine candidate
- The company is in talks with several countries for supply agreements of its vaccine, adding that it had already received about $400M for supply. The P-III study of mRNA-1273 is being conducted in collaboration with NIH and BARDA with an anticipated completion of enrollment in Sept’2020
- Moderna has received $1B from the US government under a plan to ramp up vaccine development. The company’s vaccine candidate is one of the few that have already advanced to the final stage of testing
Click here to read full press release/ article | Ref: Reuters | Image: PharmaShots