Global Statistics

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Updated on June 23, 2022 9:27 pm
All countries
Updated on June 23, 2022 9:27 pm
All countries
Updated on June 23, 2022 9:27 pm

Global Statistics

All countries
Updated on June 23, 2022 9:27 pm
All countries
Updated on June 23, 2022 9:27 pm
All countries
Updated on June 23, 2022 9:27 pm
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How Was The Covid Vaccine Made

Vaccine Clinical Trial Process

Was the COVID-19 vaccine made too quickly?

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.

If I Am Taking Anticoagulants Can I Get The Covid

Patients on blood thinners are asked to speak with a healthcare provider because the vaccine is given intramuscularly, which increases the risk for bleeding. The vaccine itself does not increase the risk for this group of patients.

Find out more in this Parents PACK article, “Medications and COVID-19 Vaccines: What You Should Know.”

Rush To Fill The Vials

The flow of vials is narrowed to a single-file line. Machines inject 0.45 ml of a concentrated vaccine solution into each vial, enough for six doses after dilution. The vials are sealed with foil and capped with purple lids, at a pace of up to 575 vials per minute.



The vaccine is chilled but warms up quickly during the bottling process, and the mRNA will deteriorate if left unfrozen for too long. Kalamazoo has limited time, about 46 hours, to get the liquid vaccine into vials and then into deep freeze.


Recommended Reading: Did Hank Aaron Get Covid Vaccine

How Long Will Vaccine Immunity Last

We are still learning how long immunity lasts after infection or vaccination. The latest information shows that:

  • Following infection people are not likely to be re-infected within 90 days of infection. However, they are working to learn more about immunity following infection. While some people have been re-infected after recovering from COVID-19, the number of people who have experienced this is small compared with the total number of people who have been infected.
  • Following vaccination with the mRNA vaccines, people are immune for at least 6 months and likely much longer. The same is likely to be true for the adenovirus-based vaccines too, but we are still waiting for data. Based on the elements of the immune response activated after vaccination with either the mRNA or adenovirus vaccines, it is likely that immunity will be long-lived. But time will tell, and if the virus changes in a way that evades immunity generated by vaccination, that would also affect the duration of protection.

New Approach To Vaccines

International: COVID

mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, they teach our cells how to make a proteinor even just a piece of a proteinthat triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.

Also Check: Did Hank Aaron Get Covid Vaccine

Why Did Your Group Wait Longer Than The Other Trials Such As Those Run By Pfizer Astrazeneca And Moderna To Release Its Phase Iii Protocol

All the way through I think weve followed the normal processes, and actually, for our studies, weve got five publications on the clinical trials. All of the data are out there for people to see. And its a bit perplexing that theres this constant accusation of a lack of transparency. Its actually something that, as a university, were absolutely committed to and have been doing all the way through.

What we normally do with our research projects is write a protocol paper, and BMJ Open is one of the places we usually launch those. I have to say that, in this pandemic, weve just been a bit busy. We didnt focus on publishing a protocol paper as weve gone along we just said that well put it in the publications when we get there. But I think its just the scale of what weve been doing as a small university research group: we just couldnt do everything that maybe the big pharmaceutical companies could.

It’s Time To Fill Finish And Package The Investigational Janssen Covid

Bottles of the investigational Janssen COVID-19 vaccine candidate from the vaccine launch facility in Leiden were shipped to a fill-finish site at GRAM, where the drug substance was thawed and diluted into the vaccine formulation that could potentially be administered to people.

The five-dose vials were then filled, finished with labels and packaged.

Also Check: How Long Cvs Covid Test Results

Was The Genome Of The Virus Subject To Peer Review Or Fda/cdc Oversight

The viral genome is not a product it represents scientific knowledge, so organizations like the FDA or CDC would not have oversight over the information. However, this question gets at the heart of how science is done. Scientists by their nature are skeptics, and the scientific process is designed to challenge rather than accept results. In this manner, several points offer reassurance that the genomic sequence was vetted for accuracy:

In this manner, the pillars of scientific integrity peer review and reproducibility can offer everyone reassurance that the genomic sequence was accurate not to mention the fact that vaccines based on the information have been effective at preventing infection.

How Well Does The Covid

Preparations Made For Coronavirus Vaccine

The clinical trial measured two things to evaluate how the vaccine worked:

  • Disease While 18 participants in the placebo group got COVID-19 at least seven days after having the second dose of the vaccine, none in the vaccinated group were infected. This represents 100% efficacy.
  • Immune response Now that we know what antibody levels adults experience following vaccination, studies can compare the levels in other groups to see if the vaccine works as well. These are often referred to as non-inferiority studies, meaning the vaccine is being tested in the study group to make sure it works at least as it does in another group previously studied. In the Pfizer study, average neutralizing antibody responses were more than 1.5 times higher in 12- to 15-year-olds compared with older children and young adults. While we still do not know if a certain level of virus-neutralizing antibodies indicates that an individual is protected against infection, we can be confident that vaccinated teens respond equally well, if not better than, adults.
  • Also Check: Did Hank Aaron Get Covid Vaccine

    Moderna Plans A Vaccine Plant In Africa But Critics Say The Move Isnt Enough To Ensure Access

    Throughout February, March, and April, Bancel begged for money. He asked Trevor Mundel, a top leader of the Gates Foundation. He reached out to an arm of the World Health Organization called COVAX. He phoned or scheduled Zoom calls with representatives of other government bodies and charitable foundations. He presented reasons why Moderna deserved financial assistance. Bancel became frustrated by the rejections and his requests became more plaintive.

    Look, if you dont help us, and this works, it will cost hundreds of thousands of lives, if not hundreds of millions, Bancel told one person. Its a tragedy . . . we need help.

    Each time, Bancel came up empty. Sometimes he swallowed his pride and asked an organization a second time, hoping for a change of heart. The answers remained no. Some of the potential funders deemed mRNA too risky. Some were committed to helping other companies vaccine efforts. Still others didnt have the free cash.

    Moderna managed to get some money from the Biomedical Advanced Research and Development Authority , an arm of the U.S. government, but it wasnt enough to manufacture many doses.

    But Merck never followed through on Bancels pitch. Some at Moderna got the sense that Merck executives, including the companys head of infectious disease discovery, Daria Hazuda, viewed mRNA-based vaccines as unproven, a stumbling block for an alliance.

    What Are The Expected Long

    • Most negative effects occur within 6 weeks of receiving a vaccine, which is why the FDA asked the companies to provide 8 weeks of safety data after the last dose.
    • mRNA vaccines: The mRNA in the vaccine breaks down pretty quickly because our cells need a way to stop mRNA from making too many proteins or too much protein. But, even if for some reason our cells did not breakdown the vaccine mRNA, the mRNA stops making the protein within about a week, regardless of the bodys immune response to the protein.Watch a short video of Dr. Paul Offit explaining why COVID-19 vaccines would not be expected to cause long-term side effects.
    • Adenovirus-based vaccines: Although the DNA from adenovirus-based vaccines does not break down as quickly as mRNA, the DNA cannot alter our DNA because a gene for the enzyme, integrase, is not present.

    Recommended Reading: Can I Take Advil After Moderna Vaccine

    The Development Process Was So Fast How Do We Know Its Safe

    Making sure all vaccines, including COVID-19 vaccines, meet standards for safety and effectiveness is one of the Food and Drug Administrations highest priorities. The FDA uses a lifecycle approach to monitor vaccines from studies done before testing in humans through after a vaccine is available.

    Although the development of the COVID-19 happened at warp speed, no science was skipped over, says Dr. Sawczuk. Rigorous clinical trials took place to ensure safety and efficacy. In fact, I was one of the first to participate in the clinical trial that took place at Hackensack Meridian Health and trust the process was conducted with the highest level of safety standards.

    So How Do You Make These Vaccines

    Allen Fire Department receives 200 COVID

    It depends on the platform. For viral-vectored vaccines, you take some of your harmless cold virus after you have added the spike protein DNA to it and grow it in a cell culture. Although the virus has been altered so it cant reproduce in the body, it can still replicate in the specially designed cells in this cell culture.

    Youll then have this bulking up of the virus over the course of a few days, anywhere from four litres of cell culture up to maybe 20, 30 litres. Really high-scale production can be carried out in steel tanks the manufacturing environment can look a bit similar to a super-clean, sterile brewery. You have to make sure that your cells are in the best environment possible for them to live and to allow the virus to grow. This requires monitoring many environmental factors in and around the cell culture temperature, oxygen and CO levels, acidity and so on.

    You end up with this liquid that is full of the virus that youre interested in. But its also full of materials that you dont want. So then you have what we call downstream processing, where youre purifying the virus vaccine away from all of the other components that youre not interested in.

    That downstream process is very important and is highly controlled and evaluated. It involves a lot of filtration and chromatography. At the end you have to have a very safe sterile product that contains only what you want.

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    Is It Safe To Get The Covid

    The CDC recommends waiting until your symptoms go away and you are no longer isolating. If you happen to be infected, but dont know because you have not yet developed symptoms or you have an infection without symptoms, the vaccine is not likely to be harmful. It would increase your bodys immune response against the virus.

    How Did The Research Help

    Using their prototype coronavirus, the researchers studied the spike protein, which appears on the surface of coronaviruses. These spikes let the coronavirus latch onto cells in our body. When the bodys immune system sees the spike protein, it makes antibodies to try to protect the body from infection. This makes it a good vaccine target.

    Traditionally, researchers would try putting the spike protein in the vaccine. When injected, the vaccine would stimulate a persons immune system to protect them from a particular coronavirus. But the team knew that during a pandemic, it would take too long to make large amounts of a specific spike protein.

    So, they studied a faster way to get a spike protein into the body. This new approach is to inject mRNA instructions for the spike protein into a persons muscle. The muscle cells then make the spike protein. And then the bodys immune system makes the needed antibodies to protect itself.

    Read Also: How Long Cvs Covid Test Results

    From Pfizer To Moderna: Who’s Making Billions From Covid

    The companies in line for the biggest gains and the shareholders who have already made fortunes

    The arrival of Covid-19 vaccines promises a return to more normal life and has created a global market worth tens of billions of dollars in annual sales for some pharmaceutical companies.

    Among the biggest winners will be Moderna and Pfizer two very different US pharma firms which are both charging more than $30 per person for the protection of their two-dose vaccines. While Moderna was founded just 11 years ago, has never made a profit and employed just 830 staff pre-pandemic, Pfizer traces its roots back to 1849, made a net profit of $9.6bn last year and employs nearly 80,000 staff.

    But other drugmakers, such as the British-Swedish AstraZeneca and the US pharma Johnson & Johnson, have pledged to provide their vaccines on a not-for-profit basis until the pandemic comes to an end.

    Whether the market remains a money-spinner in the future depends on whether the vaccines become the type that need just a one-off shot as for measles or if regular vaccinations will be required, such as for flu. But in the immediate future, there are big financial returns up for grabs.

    Here, we look at who is in line for the biggest gains and which shareholders have already made fortunes.

    You Dont Need A Biologist On Board To Make These You Need A Chemist

    Coronavirus: Unproven COVID-19 vaccine made available in China

    Find your bookmarks in your Independent Premium section, under my profile

    With Covid-19 vaccines widely available, the scientist behind experimental technology used by pharmaceutical companies Pfizer and Moderna has explained what was baked into the first batch off the production line.

    Dr Drew Weissman, a professor in the University of Pennsylvanias Perelman School of Medicine, is one of the pioneers of the vaccine formula called Messenger RNA . He collaborated with Pfizer and BioNTech on their version of the vaccine.

    He told The Independent that the vaccine, unlike any that has been developed previously, contains a new technology that delivers genetic code or directions that instructs the body to create a copy of the Covid-19 virus spike protein, which prompts an immune response.

    The mRNA is produced by an enzyme that copies DNA that contains the protein to be produced, Mr Weissman said.

    Four lipids are used to create the lipid nanoparticle that self-assemble with the mRNA. They are all created synthetically. The cationic lipid, which is the main function component is proprietary to companies.

    Dr Weissman explains the Covid-19 vaccines contain only the synthetically created mRNA genetic code and four lipids, known as lipid nanoparticles, in contrast to traditional vaccines that are created within living cells and contain components of a virus.

    None of this is made in mammalian cell lines, he said.

    and polysorbate-80, sodium chloride, as well as ethanol.)

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    Trial And Authorization Status

    Phase I trials test primarily for safety and preliminary dosing in a few dozen healthy subjects, while Phase II trials following success in Phase I evaluate immunogenicity, dose levels and adverse effects of the candidate vaccine, typically in hundreds of people. A Phase III trial consists of preliminary safety and immunogenicity testing, is typically randomized, placebo-controlled, while determining more precise, effective doses. Phase III trials typically involve more participants at multiple sites, include a control group, and test effectiveness of the vaccine to prevent the disease , while monitoring for adverse effects at the optimal dose. Definition of vaccine safety, efficacy, and clinical endpoints in a Phase III trial may vary between the trials of different companies, such as defining the degree of side effects, infection or amount of transmission, and whether the vaccine prevents moderate or severe COVID19 infection.

    A clinical trial design in progress may be modified as an “adaptive design” if accumulating data in the trial provide early insights about positive or negative efficacy of the treatment. Adaptive designs within ongoing Phase IIIII clinical trials on candidate vaccines may shorten trial durations and use fewer subjects, possibly expediting decisions for early termination or success, avoiding duplication of research efforts, and enhancing coordination of design changes for the Solidarity trial across its international locations.

    How Do The Vaccines Work

    • There are three main types of COVID-19 vaccines: messenger RNA , protein subunit and vector.
    • All three vaccine types either deliver, or cause our bodies to make, harmless proteins like the ones found on the surface of the COVID-19 virus.
    • The vaccine teaches our immune system to recognize the virus. After we are vaccinated, if we are exposed to the virus, our immune system recognizes, attacks and blocks the virus.

    Read Also: How Long Cvs Covid Test Results

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