Our Ruling: Missing Context
We rate this claim MISSING CONTEXT;because without additional context it might be misleading. Vaccines require specific targets against which they train the immune system. COVID-19’s spike protein was identified nearly 20 years ago as a potential vaccine target during the development of the SARS vaccine, following the 2003 SARS outbreak.;This has helped expedite the vaccine process, given that vaccine platform technologies;have advanced in recent years, as well. Another accelerant was the commercial-scale production of COVID-19 vaccine doses prior to FDA clearance, called at-risk manufacturing, when early results appeared promising. Finding suitable vaccine targets for HIV, cancer and the common cold has been more difficult in comparison as these diseases have either elusive or highly variable targets.;
What Were The Reactions To The Ruling
AstraZeneca welcomed the court’s decision and said in a statement it will deliver substantially more than 80 million doses by the end of June 2021: “All other measures sought by the European Commission have been dismissed, and in particular the Court found that the European Commission has no exclusivity or right of priority over all other contracting parties.”
The European Commission wanted substantially more than the court ordered – a total of 120 million vaccine delivered by the end of June 2021, and 300 million doses by the end of September.
The Commission nevertheless claimed the ruling as a victory. Ursula von der Leyen commented that the “decision confirms the position of the Commission: AstraZeneca did not live up to the commitments it made in the contract”.
India To Supply Covid Vaccines To Other Nations After Increased Production: Modi
2 min read.Neetu Chandra Sharma
- Modi urged countries to focus on addressing the pandemics economic effects and said international travel should be made easier, through mutual recognition of vaccine certificates
|Listen to this article|
New Delhi: As India ramps up production of covid-19 vaccines, the country will be able to resume supplies to others nations too, Prime Minister Narendra Modi said on Wednesday.;
Speaking at the global covid-19 summit held virtually, Modi said Earlier this year, we shared our vaccine production with 95 other countries, and with UN peacekeepers. And, like a family, the world also stood with India when we were going through a second wave.”
As newer Indian vaccines get developed, we are also ramping up production capacity of existing vaccines. As our production increases, we will be able to resume vaccine supplies to others too. For this, the supply chains of raw materials must be kept open,” said Modi.
Modis statement comes a day after union health minister Mansukh Mandaviya on Monday said that India will resume exports of covid-19 vaccines from October to meet its commitment for global supplies through COVAX, a multilateral initiative aimed at fostering global access to coronavirus vaccines from October.
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But Making An Mrna Vaccine Is Different
Yes, with the nucleic acid vaccines you dont have any cells. You dont need any vats to grow anything in. You use a machine, a synthesiser, to add each nucleic acid onto the next in the right sequence so that you end up with the full-length RNA sequence that encodes the spike protein.
Then you have to take that and mix it with your little lipid droplets. You mix these components together in a very controlled way so that youve produced these tiny little droplets that are at the nanometre scale, with your RNA on the inside, covered by these lipids.
And again, you have to analyse them and show that they meet a very tight specification of size and what theyre composed of and be able to prove the quality of your product.
Vaccine Clinical Trial Process
Phase one: Checks the safety of a vaccine and determines whether it triggers an immune response in a small group of healthy humans.;
Phase two: Widens the testing pool to include groups of people who may have the disease or be more likely to catch it, to gauge the vaccines effectiveness.;
Phase three: Expands the pool up to the thousands to make sure the vaccine is safe and effective among a wider array of people, given that immune response can vary by age, ethnicity, or by underlying health conditions.
The COVID-19 candidates, like all vaccines, essentially aim to instruct the immune system to mount a defense, which is sometimes stronger than what would be provided through natural infection and comes with fewer health consequences.
To do so, traditional vaccines use the whole coronavirus, but in a killed or weakened state. Others use only part of the viruswhether a protein or a fragment. Some transfer the instructions for coronavirus proteins into an unrelated virus that is unlikely or even incapable of causing disease. Finally, cutting-edge vaccines under development rely on deploying pieces of the coronaviruss genetic material, enabling our cells to temporarily make coronavirus proteins needed to stimulate our immune systems.
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What About Other Vaccines
The Pfizer jab is mostly made in Puurs, in Belgium, and a manufacturing site has also been set up in the German town of Marburg. The UK has ordered 100 million doses of Pfizer.
On 20 April, the European Commission said the EU had exported 25 million doses to the UK, but it was unaware of any vaccines going the other way. EU leaders considered banning exports of vaccines to the UK but decided against.
Vaccines may be produced in one place but “filled and finished” – put into vials and prepared for export – in another.
The Moderna vaccine is produced in Switzerland and put into vials in Spain – the UK has ordered 17 million doses
The Johnson & Johnson/Janssen jab is made in the Netherlands – the UK has ordered 30 million doses
And some components used in the process may be made at yet another location.
For example, the UK company Croda is supplying a component to Pfizer to make its vaccine.
So If Not Moderna Or Pfizer Then What
Without Moderna, Dr Fox believes;the push for mRNA onshore manufacturing becomes a much longer-term strategy.
Supplied: Archa Fox
Part of that approach would be about investing in the biotechnology’s wider potential long-term future, which the federal government has acknowledged is part of the strategy.
“This is a really big opportunity for Australia to become a global player in this new biotech, that is based around RNA,” she;said.
“We could make COVID-19 vaccines for us and future boosters, and vaccines against variants that arise specific to our region.”
IDT’s proposal is understood to involve this sort of “Australian-made” strategy.
Last month, the company told the ASX it was in discussions with the Monash Institute of Pharmaceutical Sciences and the Victorian government to locally manufacture an mRNA vaccine at its Melbourne facility.
The MIPS;initiative is being headed up by Colin Pouton. His team’s mRNA COVID-19 vaccine the one being partially made in Belgium is about to go into human trials with help from a $5 million grant from the Victorian government.
“It’s a little different to the existing approved mRNA vaccines,” he said.
“It’s probably going to be particularly useful for booster vaccines against variants of concern.”
Professor Pouton did not put a time frame on how long full-scale production of his vaccine could take.
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How Effective Is The First Of The Two Doses Of The Vaccine
An immune response is already formed 2 to 3 weeks after the first dose of the vaccine, which may protect against severe forms of COVID-19. However, after the second vaccine, immunity to COVID-19 is further enhanced and a longer duration of immunity is ensured. Stronger immunity also develops after 2 to 3 weeks following the second vaccination.
How Has Development Been Sped Up Amid The Pandemic
Under normal circumstances, during which the stages of vaccine development occur sequentially, a vaccine takes eight to fifteen years on average to get from the lab into the hands of health-care providers. The fastest a vaccine had ever been developed before this pandemic was four years. Following the emergence of COVID-19, however, researchers around the globe accelerated the process by carrying out stages of development simultaneously and by looking to new vaccine technologies. I think what were seeing is remarkable, says Paul Offit, director of the Vaccine Education Center at the Childrens Hospital of Philadelphia. It is a scientific tour de force.
The U.S. Operation Warp Speed timeline hinged on overlapping stages of development; mass production started for strong candidates even while clinical trials were ongoing. Before their vaccines were approved, Moderna received $2.5 billion in a deal under Warp Speed that included the purchase of one hundred million doses, while Pfizer and BioNTech signed a $1.95 billion contract to manufacture and distribute one hundred million doses of their vaccine. Shortly after President Joe Biden took office, his administration bought another hundred million doses each from these companies.
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About Vaccines Used In Lithuania
Currently, three different vaccines are used in Lithuania:
- COVID-19 Vaccine Moderna vaccine manufactured by Moderna
- Comirnaty vaccine manufactured by Pfizer / Biontech
- AstraZeneca vaccine manufactured by AstraZeneca together with the University of Oxford
Safety and efficiency
All vaccines used in Lithuania are safe and effective. They are effective in protecting against severe forms of COVID-19 disease and the majority of vaccinated people are protected from getting infected with COVID-19 in general.
Millions of people have been vaccinated with these three vaccines all around the world, including such countries as the USA and the United Kingdom. No long-term side effects have been observed in clinical trials of COVID-19 vaccines or in mass vaccination of general population in various countries.
Rate of the formation of immunity
Two doses of the vaccine are needed to achieve full effectiveness of vaccination. However, resistance develops 2-3 weeks after the first vaccination, which may protect you from severe forms of COVID-19. The second vaccine further enhances the immune response and ensures that resistance to COVID-19 would persist longer.
Possible side effects
Vaccination with any of these vaccines may cause short-term, non-hazardous side effects in humans. For example, pain, redness and swelling at the injection site, headache, muscle and joint pain, tiredness, fever, chills. These symptoms are also common with other vaccines, such as the vaccine against the flu.
Can Vaccines End The Pandemic
Even with a variety of vaccines approved for emergency use, there remains the tremendous challenge of making enough of them for the worlds population. Though multilateral initiatives such as COVAX and individual governments are investing billions of dollars to expand production plants, current global manufacturing capabilities are far below whats neededonly about a dozen countries have the capacity to produce COVID-19 vaccines.
This task has not only motivated countries to scale up production, but also pitted them against one another amid a limited vaccine supply. Wealthy countries including Australia, Canada, and the United States struck deals with manufacturers to provide their countries with more than enough doses for their populations, leaving lower-income countries unable to immunize but a small proportion of their citizens in the coming months. China and India have large vaccine industries, which allows them to reserve some of their vaccine supplies for their own residents. Experts including CFRs Thomas J. Bollyky have warned that bidding wars over vaccines lead to inequitable distribution and, ultimately, fail to eliminate the risk of new outbreaks. In a , WHO Director General Tedros Adhanom Ghebreyesus echoed this, writing that leaving large swaths of the global population unprotected is epidemiologically self-defeating.
For Foreign Affairs, experts lay out a strategy for the long fight against COVID-19.
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What About India’s Vaccine Exports
India was supplying vaccines to its immediate neighbours and to the global Covax scheme for poorer countries until it halted exports in April, leaving Covax struggling to meet its commitments.
Countries like Nepal, Bangladesh and Sri Lanka are now relying on Chinese vaccines and donations from other countries.
Covax – which has turned to other sources for vaccines – confirmed to the BBC they are in touch with the Indian government about resuming exports – but there’s no date agreed as yet.
The SII has said their priority remains India’s own needs – and they may not export again until the end of this year.
The row over Meng Wanzhou’s detention in 2018 strained China’s relations with Canada and the US.
Access To Expertise And Specialist Knowledge
Vaccine manufacture requires personnel with technical competence and knowledge of the latest technologies and global regulatory requirements. Globally, there is a shortage of people with these skills, and hiring and training staff can be a challenge for even experienced manufacturers.
The UK Government has recently announced funding for skills training in vaccine manufacturing .
Accessing the proprietary knowledge needed for vaccine production can also be challenging for manufacturers. This can include technical information about the type of cells used to grow virus proteins in, or the production software used.
Knowledge of a vaccines manufacturing process can offer competitive advantage, and many vaccine patents protect the manufacturing process itself rather than the product produced. Historically, manufacturers have reverse-engineered the manufacturing processes used by their competitors in order to produce their own version of a vaccine, however this can be time consuming and costly.
To improve access to information, the World Health Organization is establishing a COVID-19 technology access pool to facilitate the sharing of knowledge, data and intellectual property globally. In another initiative, a group of six pharmaceutical companies researching antibody treatments for COVID-19 obtained permission to share technical information about their manufacturing processes and platforms, under anti-trust law in the US.
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Why Manufacturing Covid Vaccines At Scale Is Hard
By Anthony King, additional reporting by Sanjay Kumar2021-03-23T09:40:00+00:00
The first Covid-19 vaccine candidate went into the arms of volunteers in Seattle in March 2020. It was an mRNA vaccine from Moderna. The mRNA candidate from BioNTech and Pfizer followed in April. By December 2020, these two had become the first vaccines to be approved by the US Food and Drug Administration . Hot on their heels are rivals based on adenovirus vectors from AstraZeneca and Johnson & Johnson, as well as Sputnik V from Russia.;
Early successes in developing vaccines by upstarts like Moderna and BioNTech papered over the struggles of vaccine heavyweights like Merck, GSK and Sanofi. But those companies that have surmounted the challenges of development now face the next phase: manufacturing doses on an enormous scale. And as Matt Hancock, the UKs health secretary, told the House of Commons on 18 March the process of manufacturing vaccines is complicated, and subject to unpredictability.
The Vaccines Manufacturing and Innovation Centre will be the UKs first national vaccines manufacturing and innovation facility
A Vaccine Patch Could Someday Be An Ouchless Option
The first protein subunit COVID-19 vaccine to become available will likely come from the biotech company, . In contrast to the three vaccines already authorized in the U.S., it contains the spike protein itself no need to make it, it’s already made along with an adjuvant that enhances the immune system’s response, to make the vaccine even more protective.
Protein subunit vaccines made this way have been around for a while. There are vaccines on the market for hepatitis B and pertussis based on this technology.
A large test of the Novavax COVID-19 vaccine’s effectiveness, conducted in tens of thousands of volunteers inthe United States and Mexico, is about to wrap up. Dr. Gregory Glenn, president of research and development for Novavax, told an audience at a recent webinar hosted by the International Society for Vaccines that “we anticipate filing for authorization in the U.K., U.S. and Europe in the third quarter.”
Turning plants into factories
To make the virus protein, Novavax uses giant vats of cells grown in the lab. But there’s another way to make the protein: Get plants in a greenhouse to do it.
That’s the approach being used by the Canadian biotech firm Medicago.
The plants used are related to the tobacco plant, and have been modified to contain the genetic instructions to make the viral protein.
The plants do something very valuable they make a lipid shell that surrounds a bunch of the viral proteins, with the proteins sticking out.
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How Does A Mrna Vaccine Work
mRNA vaccines contain genetic information from the virus that allows human cells to produce only the surface spike protein specific for SARS-CoV-2. Following vaccination, when the SARS-CoV-2 virus reaches the human body, the immune system recognizes its surface protein, activates the immune response, and destroys the virus.
Two mRNA vaccines are currently used for vaccination: Pfizer/BioNTech and Moderna.
The principle of action of mRNA vaccines has been known to scientists for decades. The work has been done on the basis of this principle to find effective protection against influenza, Zika, rabies, CMV viruses.
Is Pfizer Working With Operation Warp Speed
Pfizer is working very closely with the U.S. government on several fronts as we strategize and plan for our future COVID-19 vaccine distribution effort, keeping in mind that our vaccine candidate needs to clear a number of efficacy, safety and manufacturing hurdles before we submit for any FDA consideration. General Gustave Perna and the Operation Warp Speed team have offered any and all support and we are grateful for that as what we are tasked with is no simple feat.
A few areas where we have been collaborating include:
- a direct ship distribution strategy that minimizes the transportation time from our facility to the point of use,
- synchronization of our vaccine shipments with the delivery of an ancillary kit that contains supplies required to administer the vaccine, and
- a second dose inventory management system.
The combination of OWS logistics expertise coupled with Pfizers deep manufacturing and distribution expertise provides a solid foundation for success.
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