What Are The Different Data Requirements Between An Emergency Use Authorisation And A Conditional Marketing Authorisation And What Are The Potential Consequences Of These
In case of a Conditional Marketing Authorisation EMA thoroughly assesses all required information to confirm that the benefits outweigh the risks of the medicine.
For instance, in addition to the data demonstrating safety and efficacy, the data submitted in a marketing authorisation application for a COVID-19 vaccine must include information on:
- the group of people to be given the vaccine
- the vaccine’s pharmaceutical quality and purity
- manufacturing and controls of batches
- compliance with international requirements for laboratory testing and conduct of clinical trials
- types of immune responses
- side effects e.g. with regard to older people, or pregnant women
- labelling and package leaflet
- the way risks will be managed and monitored once the vaccine is authorised.
The Conditional Marketing Authorisation procedure provides the necessary assurance to citizens that the full range of requirements are being applied as mass vaccination programmes are rolled out including independent controls performed on vaccine batches by the network of Official Medicines Control Laboratories before the vaccine reaches the patient.
- the manufacturing process of the vaccine
- the good manufacturing practice status certification of the facilities in which the vaccine is to be manufactured
- The extent of the clinical data, including size of the safety database and efficacy clinical data analyses available.
What Are The Side Effects Of Moderna’s Booster
According to the CDC, those who got the Moderna booster dose reported fewer reactions than they did after the second dose of the vaccine. In its study, the CDC found 95% of those who got Moderna for the first round of vaccine shots chose Moderna for the booster dose.
Moderna’s booster shot is free of charge for all adults.
Who Decides How Many Vaccines A Member State Gets
Member States indicate early on in the negotiation phase with a company if they are interested in a particular vaccine and what quantity they would want to buy.
Once the contract is concluded, the vaccines are allocated according to a distribution key, based on the size of the population. So Member States receive vaccines under the same conditions on a pro-rata basis, at the same price.
Adjustments of quantities of vaccines between Member States are possible, according to their needs. For instance, a Member State may decide not to buy additional vaccines from the options negotiated, in which case other Member States can take over those options and buy more of that particular vaccine.
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What Labelling And Packaging Information Will Citizens And Health Care Professionals Get With The Covid
In order to allow for a rapid deployment of COVID-19 vaccines at large scale, the Commission has developed, with Member States and the European Medicines Agency, labelling and packaging flexibilities for a temporary period. Flexibility in the labelling and packaging requirements is expected to reduce transport costs and storage space, improving the distribution of the doses between Member States and limit possible impact on the production of other routine vaccines. Despite these flexibilities, anyone vaccinated and health care professionals will have access to all the information on the vaccine used.
An example of such flexibilities is the fact that the outer and immediate packaging may only be printed in English. Also, the package leaflet does not have to be included inside the package of the medicinal product, but will be provided separately by the vaccine company, who will be responsible for the distribution of the printed package leaflet locally in the national language.
Some Member States do not require the package leaflet to be printed in their national language. The leaflet may be printed in English only, but the information contained in the leaflet should still be available in the national language, for instance via a QR code printed in the package leaflet and also available in the EMA website in all languages.
Northern Kentucky Vaccine Providers
If you have questions or need to cancel, confirm or reschedule an appointment with any of the vaccine providers listed on this page, please contact the provider directly. NKY Health cannot confirm, schedule, cancel or change appointments with other providers and we are unable to answer questions on their behalf.
- Total Care Pharmacy, 700 Violet Road, Crittenden, Ky. Call to Schedule: 428-0900
- Total Care Pharmacy, 40 Broadway Street, Dry Ridge, Ky. Call to Schedule: 823-0200
- Wildhealth Vaccine Scheduling
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What Side Effects Can Be Expected After Vaccination
Currently, the following side effects are known:
According to the Robert Koch Institute, typical complaints after a vaccination are redness, swelling and pain at the vaccination site general reactions such as fever, headache, pain in the limbs and feeling sick are also possible. These reactions show that the vaccine is having the desired effect on the immune system and usually go away completely after a few days.
Specific side effects: No serious safety concerns have been identified to date however, the observation period for relevant vaccine side effects has currently been too short to identify such concerns.
Booster Shots And Additional Doses
Booster shots are not yet available.
But additional doses of COVID-19 vaccines are now available for those with moderately to severely compromised immune systems.
This includes people who:
- Get active cancer treatment for tumors or cancers of the blood
- Got an organ transplant and are taking medicine to suppress the immune system
- Got a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
- Have moderate or severe primary immunodeficiency
- Have advanced or untreated HIV infection
- Get active treatment with high-dose corticosteroids or other drugs that suppress immune response
Talk to your doctor to see if getting an additional dose is right for you. If you meet these criteria, you can book your third dose at My Turn.
See questions and answers about additional doses.
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Americans Are On Edge Over Omicron As Cases Surge And The Holidays Loom
The United States is a week away from a Christmas that was supposed to feel far more festive than the last. Two weeks away from a new year in which it was once possible to imagine the pandemic fading into the background of mostly normal life.
Instead, nearly 1,300 Americans are dying every day from the coronavirus, more than 120,000 are testing positive, and millions more are experiencing a kind of fear that very particular kind amplified by a lack of information, and by the knowledge that even what seems clear this afternoon could change by evening that they thought they had left behind.
Its as bad as we expected, Gov. Kathy Hochul of New York said on Thursday, amid a statewide surge that epidemiologists tie to the new Omicron variant. Were asking people to follow common sense. Get vaccinated, get boosted. Please dont take a chance.
While officials say vaccinated people with Omicron can expect asymptomatic or mild infections, those who are unvaccinated should not expect the same.
For the unvaccinated, you are looking at a winter of severe illness and death for yourself, your families and the hospitals you may soon overwhelm, Jeffrey D. Zients, the White Houses coronavirus response coordinator, said on Friday.
Dr. Anthony S. Fauci, President Bidens chief medical adviser, likened the current situation to the darkest moments of a war.
Mitch Smith and Abby Goodnough contributed reporting.
What Does The Moderna Booster Shot Do
A COVID-19 booster shot — whether from Moderna, Pfizer or Johnson & Johnson — tops off your immune response and guards against a breakthrough COVID-19 infection as the vaccine’s effectiveness decreases over time.
Recent studies of the Pfizer and AstraZeneca vaccines show that their effectiveness can begin to wane after six months. Moderna said early data suggests that those who received the Moderna vaccine in 2020 are showing a higher rate of breakthrough COVID-19 infections than those vaccinated this year, suggesting the need for a booster to maintain high levels of protection.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.
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When Will The Vaccine Allow The Control Of The Pandemic
For some known communicable diseases, it is understood that herd immunity allowing to control a pandemic and eventually eradicate a disease requires around 70% of the population to have protection either from vaccination or previous infection.
Depending on the pace of vaccination and natural infections, the pandemic might be controlled by the end 2021 in Europe.
Vaccination: Side Effects And Adverse Events After Covid
Short term vaccine side effects fall into one of three categories:
1) Local reactions, at or near the injection site
Systemic reactions
Allergic reactions
This discussion addresses the local and systemic side effects. Although COVID-19 vaccination will help protect you from getting COVID-19 disease, you may have some short term local or systemic side effects from the vaccination, which are normal signs that your body is building protection against COVID-19.
While we do not yet know all of the possible vaccine side effects, some vaccinated people have had local reactions such as pain or redness or tenderness at the injection site. In terms of systemic side effects, a small number of vaccine recipients have had transient symptoms such as fatigue, nausea, chills, fever, headache or other body aches for a few days. These local or systemic side effects do NOT mean that the vaccine has given you a COVID-19 infection. Rather, these expected side effects mean that the vaccine is causing your bodys immune system to react and create antibodies to fight off the virus that causes COVID-19 if you are exposed in the future.
A small number of vaccine recipients have experienced swollen lymph nodes. For the two mRNA vaccines, these expected side effects are more common in younger people than older people and with the two-dose vaccine series, they are more common after the 2nd dose than after the first dose.
To reduce pain and discomfort where you or your child got the shot:
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Can I Get A Covid
You cant have a COVID-19 vaccine and another vaccine including the flu shot on the same day. You should wait at least 7 days between having a dose of the Pfizer, Moderna or AstraZeneca vaccine and any other vaccine.
You arent required to have COVID-19 and flu vaccines in any particular order. The order will likely depend on vaccine availability, so you should have whichever vaccine you can access first.
If youre having the Pfizer vaccine, this also means you may be able to receive another vaccination in between your 2 doses, if appropriate.
Ask your doctor or pharmacist for more advice on when to schedule your vaccinations.
In special cases, your healthcare provider may consider shortening the time period between the different vaccines or they may suggest you receive the vaccines on the same day. This will only be considered if:
- theres a high risk that youll be exposed to one of the diseases
- its highly likely that the opportunity of receiving either vaccine will be missed
If this is proposed, youll be counselled about any possible adverse events from each vaccine. Youll be advised to report any adverse events.
Q: What About Vaccines Received Outside The Us
A: If you have received all recommended doses of a COVID-19 vaccine listed for emergency use by the World Health Organization , you do not need additional doses of an FDA-authorized COVID-19 vaccine . If you have not received all the recommended doses of a WHO-approved vaccine, you should complete an FDA-authorized vaccine series.
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I Received Monoclonal Antibodies Or Convalescent Plasma As Part Of My Covid
Currently, there is no information on how well the COVID-19 vaccines work in people who received monoclonal antibodies or convalescent plasma. Evidence suggests it is rare for people to get infected again in the 90 days after they first got ill. Because of that, people who have had one of these treatments should wait for at least 90 days after the treatment before getting vaccinated.
If you received the first dose of vaccine and then received monoclonal antibodies, you should wait 90 days before receiving your second dose of vaccine. However, if you received the first or second doses of vaccine before the full 90 days passed, no repeat doses of vaccine are necessary.
New York Reports A Record Number Of Coronavirus Cases For One Day
New York officials reported 21,027 new coronavirus cases on Friday, the highest single-day total since the earliest days of pandemic, when the availability of testing was not as widespread as it is now.
The data, which reflected test results for Thursday, showed a drastic change in the viruss presence in New York. For weeks, case counts had been rising steadily, primarily because of a winter surge driven by the Delta variant. But the spike in recent days is because of the fast-spreading Omicron variant, epidemiologists believe.
Dr. Wafaa El-Sadr, an epidemiology professor at Columbia University, said that for now, the Omicron variant seemed to be infecting more people in New York than in other parts of the country.
In that sense, this sort of reminds me of March 2020, she said. We are taking the first wave of Omicron in this country, and, similar to the last time in New York, we will be essentially the testing ground for what this variant will do.
Virus cases in the state have risen 56 percent in the past 14 days, and hospitalizations, though far below the peaks of the past two years, have climbed 25 percent in the same period, according to The New York Timess tracker. As of Thursday, the states positivity rate had climbed to nearly 8 percent.
The surge in cases, Gov. Kathy Hochul said on Friday, is a reminder that the pandemic is not over yet and we must take extra care to keep ourselves and each other safe.
Matt Stevens contributed reporting.
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When Is It Time To Get A Covid
If you got Moderna or Pfizer, six months after the date of your second shot listed on your vaccination card is when you’re eligible to receive your booster dose. The CDC and other health authorities are now urging you to get your booster as soon as you’re eligible, to keep your immune response against omicron, delta and other coronavirus variants as strong as possible. Two months after the Johnson & Johnson vaccine is the time for a booster .
On Dec. 2, Biden also outlined a plan for Medicare to contact the 64 million people it serves and for AARP to reach out to its 38 million senior members. Pharmacies like Walgreens, CVS and RiteAid should also contact people who got a vaccine at their retail stores when it’s time to schedule another dose.
Boeing Joins Other Federal Contractors In Dropping Its Vaccine Mandate
Boeing said on Friday that it had suspended a vaccination requirement for employees after a court blocked enforcement of an executive order by President Biden instructing federal contractors to impose such mandates.
The announcement came after several other companies, including Amtrak, General Electric, Union Pacific and BNSF Railway, recently dropped their vaccine mandates, citing the court order. Some employers have said that the vaccine mandate has made it harder to hire people at a time when workers are in short supply.
Boeing said that about 92 percent of its more than 110,000 U.S. employees were fully vaccinated or had received exemptions from the mandate. Overall, about 72 percent of all adult Americans have received the one or two shots of coronavirus vaccines regulators have determined provide protection from the virus. Some companies that required employees to be vaccinated months ago, like United Airlines, a Boeing customer, have said that close to 100 percent of their employees have been vaccinated.
After careful review, Boeing has suspended its vaccination requirement in line with a federal courts decision prohibiting enforcement of the federal contractor executive order and a number of state laws, the company said in a statement.
On Tuesday, Amtrak said it was dropping its mandate, though about 97 percent of its work force had already received a shot or an exemption. Fewer than 500 Amtrak employees have not been vaccinated, its chief executive said.
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How Do We Know If The Vaccine Is Safe
Its important to know that vaccines go through more testing than any other pharmaceuticals. First, small groups of people receive the trial vaccine. Next, vaccine is given to people with certain characteristics . Then, vaccine is given to tens of thousands of people and tested for effectiveness and safety.
After that, the CDCs Advisory Committee on Immunization Practices looks at the data to see whether the vaccine works and is safe. They give advice to the United States Food and Drug Administration . The FDA looks at the data and the advice from the ACIP and decides whether to approve the vaccine. The vaccine is only approved after all of these steps are done, and the experts are sure that it works and is safe.
Vaccine Rollout: International Comparison
In the following two charts you can see how Australias vaccine rollout compares with other countries, in terms of doses administered per 100 people.
This first chart adjusts for the fact that countries started administering vaccines on different dates. It shows how Australia compares to select countries at equivalent points in their vaccine rollouts.
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