When will Pfizer vaccine be fully approved by FDA?

On Aug, the U.S. Food and Drug Administration (FDA) announced that it had approved the Pfizer-BioNTech (Pfizer) COVID-19 vaccine. This vaccine will be marketed as Comirnaty and is fully approved to prevent coronavirus disease in people 16 years of age and older.

Will citizens know which vaccine they will be getting?

See full answerYes.When vaccines receive conditional marketing authorisation, the package leaflet with details on the specific vaccine will be translated into all languages and published in electronic form by the Commission.All health care professionals and all patients would therefore have access to a leaflet in electronic form in their own languages.The vaccine companies are responsible for putting in place the necessary mechanisms to ensure that each patient receives the package leaflet in print form in his/her language upon request without burdening healthcare professionals administering the vaccine.

How will the commission support EU member states in the rolling-out of COVID-19 vaccines?

See full answerThe Commission stands ready to support Member States to ensure the smooth deployment of COVID-19 vaccines. A number of EU instruments in the programming period 2021-2027 can offer financial support in this regard.For instance, investments to support health reforms and resilient, effective and accessible health systems are eligible under the Recovery and Resilience Facility (RRF), and can be included in the national Recovery and Resilience Plans. Furthermore, the Cohesion Policy funds (European Regional Development Fund - ERDF and European Social Fund Plus - ESF+) as well as the REACT-EU programme can provide financing to Member States and their regions to strengthen their health systems, both in terms of managing and recovering from the current health crisis and as well as ensuring their resilience in the longer term.

What is the COVID-19 vaccine introduction toolbox?

The COVID-19 vaccine introduction toolbox equips all countries to prepare for and implement COVID-19 vaccination by providing guidance, tools, and training. This toolbox is intended to support Ministries of Health, health workers, partner organizations, and other stakeholders.

Which vaccine was approved by the FDA?

On Aug, the U.S. Food and Drug Administration (FDA) announced that it had approved the Pfizer-BioNTech (Pfizer) COVID-19 vaccine. This vaccine will be marketed as Comirnaty and is fully approved to prevent coronavirus disease in people 16 years of age and older.

Where are vaccine passports required?

In the United States, New York and California also require proof of vaccination for some events. France, Germany and Israel also have vaccine passports.

Are there any side effects from the COVID-19 vaccine?

Like any vaccine, COVID-19 vaccines can cause mild, short term side effects, such as a low-grade fever or pain or redness at the injection site. Most reactions to vaccines are mild and go away within a few days on their own. More serious or long-lasting side effects to vaccines are possible but extremely rare.

Is it safe to take paracetamol before receiving the COVID-19 vaccine?

Taking painkillers such as paracetamol before receiving the COVID-19 vaccine to prevent side effects is not recommended. This is because it is not known how painkillers may affect how well the vaccine works.

Who orders the COVID-19 vaccines for EU member states?

Member States place orders with vaccine suppliers directly, indicating the timing and place of deliveries of vaccines, for instance, and specifying logistic aspects.

How will the EU support industry in ramping up production and preparing for future strains of the COVID-19 virus?

See full answerPrivate-public cooperation will be key to improving vaccine production capacity and overcoming bottlenecks in the supply chain. The bio-defence preparedness plan “HERA Incubator” will facilitate contacts and cooperation between regulators, other public authorities and industry and between industry players involved in the supply chain. The Task Force for Industrial Scale Up will act as a one-stop-shop helpdesk for any queries and operational support to address bottlenecks in production and supply of raw materials.The Commission will foster the creation, if need be, of a voluntary, dedicated licensing mechanism to enable sharing of technical know-how through pre-production industrial partnerships in order to increase production.

How is COVID-19 vaccination distribution and deployment organised?

See full answerThe Commission has been asking national authorities to prepare as early as possible for organising the fast and accessible deployment of vaccines, according to national vaccination plans and has issued guidance on the large-scale vaccination deployment.In July 2021, we hope that Member States should have vaccinated 70% of the entire adult population.The Commission, Member States and the EMA are working with companies to use the EU's potential for increased vaccine manufacturing capacity to the fullest.The Commission is following the developments of national vaccination plans very closely and provides support notably by organising joint procurement for vaccination supplies, such as syringes and needles, and running a stress test of the national vaccination plans ahead of deployment together with the ECDC.

What is the origin of COVID-19?

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel severe acute respiratory syndrome coronavirus. It was first isolated from three people with pneumonia connected to the cluster of acute respiratory illness cases in Wuhan. All structural features of the novel SARS-CoV-2 virus particle occur in related coronaviruses in nature.

How many doses of the Sinovac COVID-19 vaccine are recommended?

See full answertake it. Persons with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from acute illness and the criteria for ending isolation have been met. Anyone with a body temperature over 38.5°C should postpone vaccination until they no longer have a fever. What is the recommended dosage? SAGE recommends the use of Sinovac-CoronaVac vaccine as 2 doses (0.5 ml) given intramuscularly. WHO recommends an interval of 2–4 weeks between the first and second dose. It is recommended that all vaccinated individuals receive two doses. If the second dose is administered less than 2 weeks after the first, the dose does not need to be repeated. If administration of the second dose is delayed beyond 4 weeks, it should be given at the earliest possible opportunity. How does this vaccine compare to other vaccines already in use? We cannot compare the vac

What are the common side effects of the COVID-19 vaccine?

Reported side effects to COVID-19 vaccines have mostly been mild to moderate and short-lasting. They include: fever, fatigue, headache, muscle pain, chills, diarrhoea, and pain at the injection site. The chances of any of these side effects following vaccination differ according to the specific COVID-19 vaccine.

Is Pfizer FDA approved?

Pfizer's COVID-19 vaccine now has full FDA approval.

What are the mild-to-moderate side effects of the COVID-19 vaccine?

Mild-to-moderate side effects, like a low-grade fever or muscle aches, are normal and not a cause for alarm: they are signs that the body's immune system is responding to the vaccine, specifically the antigen (a substance that triggers an immune response), and is gearing up to fight the virus.

What does 70% efficacy of a COVID-19 vaccine mean?

See full answere have shown different levels of efficacy. So what is vaccine efficacy? Dr Lee Hampton, a paediatrician and medical epidemiologist with GAVI, the Vaccine Alliance, explains. What is vaccine efficacy and why is it important? Vaccine efficacy measures a vaccine's protection against a disease/pathogen in a vaccine trial. If a vaccine has, for example, 70% efficacy, it means a person vaccinated in a clinical trial is around two-thirds less likely to develop the disease than someone in the trial who didn't get the vaccine. When you give a vaccine outside a clinical trial, we then refer to vaccine 'effectiveness'. Compared with efficacy, effectiveness takes into account all the complexities of the real world, outside of a controlled clinical trial setting. So far several COVID-19 vaccines seem to be highly effective in real-world settings. However, we still need to assess the full consequences for each vaccine's effectiveness a

Who distributes the COVID-19 vaccines?

Delivery to national distribution hubs is ensured by the manufacturers. Further distribution to vaccination centres is ensured by Member States, who are also responsible for the vaccination of their population.

What are the strategies implemented for the control of the COVID-19 pandemic?

See full answerStrategies in the control of an outbreak are screening, containment (or suppression), and mitigation. Screening is done with a device such as a thermometer to detect the elevated body temperature associated with fevers caused by the coronavirus.[185] Containment is undertaken in the early stages of the outbreak and aims to trace and isolate those infected as well as introduce other measures to stop the disease from spreading. When it is no longer possible to contain the disease, efforts then move to the mitigation stage: measures are taken to slow the spread and mitigate its effects on the healthcare system and society. A combination of both containment and mitigation measures may be undertaken at the same time.[186] Suppression requires more extreme measures so as to reverse the pandemic by reducing the basic reproduction number to less than 1.[187]

What is EU-FAB?

“EU FAB” project will set up a network of single or multi-user, single or multi-technology emergency response production capacity for vaccine and medicine manufacturing at European level. The project is being set up with the long-term perspective of becoming over time an asset for the future European Health Emergency Preparedness and Response Authority (HERA).