Health care professionals and public health authorities play a pivotal role in discussing vaccination against the Coffee-19 virus with their patients.Vaccines play a decisive role in preventing deaths and hospital entry due to infectious diseases.Effective emerging data indicates that the licensed Kofid-19 vaccines contribute to controlling the spread of the disease.Until the vaccination is widely achieved, each of the people who have been vaccinated and who did not take it should be aware of the additional preventive behaviors needed to combat the pandemic at the local level.
The global influence of the Kofid -19 Shura-19 has resulted in an unprecedented level of the public's interest in vaccines. This includes the focus on developing vaccines, their organizational review and monitoring their safe. A large part of this coverage occurred through the media and social media. Reports reported that some people were subjected to harmful events (side effects) to express their concerns about taking the vaccination or delaying taking the vaccination, and even strongly objection to vaccination. There are also differences in the extent of individuals' confidence in the national systems to monitor the security. Another challenge faced reporting the importance of vaccination against Kovid-19, which is that younger adults are usually clinically less than that of other infection in the Kofid-19, and therefore, many of them may see a limited value in taking the vaccination, until other data confirm that The vaccines protect against the transmission of infection and that the vaccines are effective against the engraved breeds. Therefore, the clear and consistent communication was necessary to support people in their choice to take the vaccination.
We appreciate that you, your colleagues and your illness may have a number of questions about developing the Kofid-19 vaccines and their organizational review and continuous monitoring of their safe.
the purpose
This joint statement issued by the International Coalition of Pharmaceutical Pharmaceutical authorities and the World Health Organization aims to assist health care professionals to answer the questions about the role of the organizational authorities in monitoring the Kofid-19 vaccines.It shows how vaccines are subject to an accurate scientific evaluation to determine their hormone, effectiveness and quality, and how the vaccines are closely monitored and continuously after approval.
It has been proven that vaccination contributes to reducing deaths and severe diseases caused by Kovid-19, and to reduce the transmission of the Coffee-19 virus. It is important to vaccinate the largest possible number of people and reduce the spread of the disease. The vaccination of a large percentage of the population protects the weak people, including those who cannot receive vaccines, or the small percentage of people who may be at risk of infection after vaccination. Lack of vaccination on a large scale enables the virus to continue to spread and generate mutated breeds, including some strains that may pose a greater danger. Vaccination will widely help protect people from hospitalization and contribute to a decrease in the number of patients, ultimately relieving the coffee-19 burden on health care. It will also help to allow the return of work in societies to its normal state and reopen the economies.
Vaccines and organizational process
How do regulatory authorities evaluate the Kofid-19 vaccines?
The organizational authorities accurately evaluate the scientific and clinical evidence offered by vaccine makers. Vaccine makers are legally obligated to follow specific criteria in the data they provide, and their research and manufacturing operations are subject to organizational monitoring. Full or brief data is available from clinical trials after evaluating the vaccine. Each vaccine is subject to a comprehensive evaluation of the safe, effective, and pharmaceutical quality to determine whether it can be approved. The organizational authorities use the available scientific indicators of laboratory research before clinical, clinical experiences of humans, and manufacturing information to assess the benefits and risks of candidate vaccines.
The organizational authorities may seek to obtain additional advice at the expert level from independent scientific advisory committees to use them to decide on the approval of the vaccine.These committees consist of experts in science and medicine (including infectious diseases) and general health, and often include representatives of consumers and professionals in the field of health care.
Public health agencies have a different role from the role of the organizational authorities.It puts vaccination programs and implements them, and often works with its technical advisory experts committees specializing in immunization.This includes giving priority to the population and setting them to vaccinate with specific vaccines, issuing additional recommendations, and providing information on a broader scale on vaccines and immunization.It also cooperates with the organizational authorities to monitor the vaccine safe after approval of their use.
On the global level, the public can trust the accuracy of the process used to evaluate the vaccine secure, its effectiveness and its scientifically before agreeing to its use among the population on a wider scale.
Al -Mamouniya evidence before the possible organizational permission:
Al-Mamouniyah's evidence is an essential part of every request submitted to the organizational authorities on one of the Kofid-19 vaccines.It is collected during all stages of the vaccine development process.An accurate evaluation of the insured is conducted in clinical trials and is presented to the organizational authorities for its review as part of the approval process.
All the events must be examined and reported in the request submitted to the organizational authorities from companies to obtain a marketing license. Usually, the organizational authorities require that the participants in clinical trials have been followed up for a period of not less than one or two months after receiving the final vaccine dose. In general, based on the previous experience in the field of vaccines, the majority of the incidents occur within the limits of these time frames, although there are rare harmful events that may not be known until after the widely used between the population. There is also a long -term follow -up (for example for a period ranging between 6 months and 12 months or more) for those who participated in the early stages of clinical trials for each vaccine. Many of the participants in experiments are being followed up for at least one year to assess the period of protection and safeness in the long run for individual vaccines, and the organizational authorities are interested in caring for the review of the insured data derived from these long -term experiences as part of the monitoring of the imams after approval.
Effectiveness:
Unlike the information extracted from the types of immune responses caused by the vaccine, companies must provide the organizational authorities derived from clinical trials designed well to prove that the vaccine protects against Kovid-19. The data has shown that sufficient numbers of people covered in clinical trials received the vaccine so that its effectiveness can be measured accurately (generally at least 10,000 and usually 15,000 or more people who received the vaccine, in addition to those who were in the control arm). People included in clinical trials should include a range of age groups and people with accompanying diseases. Given the unpopular Kofid-19 influence on the elderly, the clinical trials of the Kofid-19 vaccine included large numbers of elderly participants.
The clinical trials of the vaccine showed a new candidate that the vaccines very greatly reduced the infection of the Kofid-19 in people who took the vaccination, compared to a control group of people who did not receive the vaccine, and this was shown by a decrease in the number of confirmed injuries to the Corona-Sarsr-2 virus.
the quality:
Any vaccine that gets an organizational permission against Kofid-19 must be manufactured according to internationally accepted regulatory standards for good industrial practices. The organizational authorities are reviewing the data to ensure that the manufacturing process in each of the production sites is subject to good and consistent control. This includes data on the vaccine composition, purity and strength, as well as data on each step of manufacturing and controls used to ensure that each batch of vaccines is constantly on a high degree of quality. Data on the pollen must also be provided before approval. After approval, the payments may also be subject to the evaluation of the individual side of the national organizational authorities to ensure their fulfillment of national requirements, before they can be supplied.
Monitor the imams and effectiveness after agreeing to the vaccine:
After approving the use of the vaccine, the organizational authorities undertake an accurate monitoring process of its effectiveness in addition to monitoring the activities of the insurance and reducing risks (pharmaceutical alertness).It must constantly monitor vaccines with the vaccines to ensure the continued superiority of the vaccine benefits on its risks.The organizational authorities do this through the following:
It is very important that health care professionals should not be satisfied with seriously reporting any harmful events that they see with their patientIntroduction from the members of the public.The reporting of all relevant events helps the organizational authorities to assess the potential role of the vaccine in causing this fierce event, and helps in defining the insurance issues related to the vaccines that have started to be given recently.
As part of the monitoring of the insured and the review of all communications from the suspected side effects caused by vaccines, the organizational authorities have laid lists of "sensory events of special importance". These lists include some events that have been associated with other vaccines (such as hunter). Others are included in these lists because they are dangerous events that are important to monitor them closely, and if there is no evidence for its causal relationship with specific vaccines. Obtaining information on the basic rates of these expected events in people who have not received a vaccine will help ensure the possibility of speeding up any increase in reporting these events and achieving the organizational authorities in them in a comprehensive way.
Unfortunately, the widespread use of the Kofid-19 vaccines, including between the elderly and patients with underlying health conditions, will mean that there will be deaths and serious diseases with chance and have nothing to do with vaccinations.The function of each organizational body is with the concerned medical experts and vaccine makers in determining the causal relationship.There will be a special focus on monitoring the insurance among some groups of people, such as pregnant women, people with severe diseases, the elderly, children, and people who also receive vaccines to prevent other diseases.
In cooperation with public health authorities, the organizational authorities can often take decisive measures if the issue of what is related to the imams is determined.These procedures may include the following: Issuing imams' messages addressed to patients and health care workers and the local community;And update information about the products or information provided to the consumer in relation to the vaccine;And prevent the distribution of a specific batch of the vaccine;And take other regulatory measures such as the permission of the license to vaccinate a specific sub -group of the local community or cancel the license.
The notified events that are reported
The most common events that are reported in connection with the Kofid-19 vaccines are the expected side effects of the vaccine, such as headache, fatigue, muscle pain, joints, fever, chills, and pain in the injection site.These lost events are consistent with what is already known for vaccines through clinical trials.
Effective events of special importance
The organizational authorities do not agree to the vaccine and do not continue to approve it unless it is proven that the benefits of the known and potential vaccine exceed its known and potential risks.
The adaptation is one of the very rare side effects that may occur with any vaccine.There are some other informed events that included stiffness of the facial muscles, exposure to seizures, and the loss of a sense of taste or small and hearty events, but no of them has been confirmed that there is a reason causing vaccines.
Rabi Al -Mersal RNA DNA vaccines
The main event is the special attention and which is reported in terms of these vaccines, which include the Pharaoh Vertifier and our Moderna in the Modernity.The organizational authorities carefully review the reports of potential insult to determine whether they are consistent with real adherence, no and whether the vaccine was the one that caused them.Reports about the occurrence of adherence are still very rare (at a rate of 10 cases per million people taking vaccination).
Instructions for the potential manufacture management in the information bulletin/product poster for these vaccines are received.Routine vaccination procedures include putting people under observation for at least 15 minutes after vaccination and making the appropriate medical treatment within reach so that the therapeutic measure can be applied for urgent inspiration.These vaccines should not be given to people who have a known history of severe sensitivity from any pollen component.A second dose should be given from the Al -Morsal Rana vaccine to those who have suffered after taking the first dose.
Some of the other notified events occurred that include unusual bleeding, blood clotting disorders, stiffness of the facial muscles, exposure to seizures, loss of taste or smell and heart attacks.The organizational authorities monitor whether there is a causal relationship between vaccines and those sensors, and the care of their review, and is being included, if appropriate, in product information/product poster for disturbing vaccines.
Viral conveyor vaccine
These vaccines include Astrazzinica, Yansen, Gamalia, Cantino, and Piologics. On the international level, the Astrazzinica and Yansen vaccine against Kovid-19 has been associated with very rare and unusual clotting syndrome that involves the events of blood clots (blood clots) with platelet deficiency (low platelet number). This condition was called the syndrome of blood clots associated with platelet deficiency. The regulatory authorities concerned with medicines regularly meet to exchange information about cases to improve the characterization of this risk and understand this syndrome. There is less information available at the international level about the incidents that followed the taking of the Gamalia Cantallow Virtues, Kenseeno and Biologists.
The total number of communications received from blood clots in the veins or arteries (including venous blood clots or venous clots) that occurs without platelet deficiency is higher than the basic population rate expected to have the most common type of blood clots in most countries.
Automatic reporting rates differ from the thrombopholidoes associated with blood clots according to the country, and it is difficult to estimate the number of precise cases, but for the Estrazzinica vaccine, and based on its heavy use in Europe and the United Kingdom, the repetition of such events is very rare. The available estimates indicate the injury of between 10 and 15 people per million people who took the vaccination (notes that this statistic is based on some countries on the number of reports of cases suspected of infection with blood clotting syndrome associated with platelets and not the number of confirmed cases). The events of the blood clots associated with platelet deficiency in the United States have also been reported in connection with the Yansen vaccine, at a rate of about 2-3 cases per million doses given. The national organizational authorities continue to monitor the issue closely and publish updated information about the number of reported cases and the latest estimates of injury.
The cases of thrombosis were reported in the platelet deficiency after the vaccination mainly between the younger individuals, not the older.This, in addition to the risk of developing a serious disease or death associated with the high rate of the Coveyd-19 virus between middle-aged people and the elderly, led to the public health authorities in some countries to recommend that you do not start vaccinating younger individuals with the Astrazzinica vaccine.
Health care professionals should pay attention to the signs and symptoms of blood clots and platelet deficiency, as well as coagulation disorders after vaccination because clotting syndrome associated with platelets requires a specific treatment measure. Individuals who took the vaccination should be directed to immediate medical care if symptoms such as severe or continuous headaches, lack of vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain, unusual skin bruises, should be directed. Or skin stains (purple, red or small structure on the skin) that mostly occur within about 4-20 days after vaccination, and if some cases have already been reported after 20 days of vaccination. This information is included in the product information/product poster for vaccines in the form that the organizational authorities approved.
Questions and answers about the Cofide-19 vaccines
Q: How was vaccines developed so quickly?Does this mean that there is something that violates its safe and effective?
A: The speed of developing the Kofid-19 vaccines has not been unprecedented for several reasons, but the requirements and effectiveness of the vaccines were not disturbed.The development of vaccines has been facilitated through the following:
س: هل ستؤثر Rabi Al -Mersal RNA DNA vaccines على الحمض النووي (الدنا) لمتلقي اللقاح؟
A: No.It has not been proven that the tranas in the vaccine merges itself into the genes of the pollen recipient, as it decomposes within the following weeks to take the vaccination.The Mercy Rana vaccines contain genetic instructions for our cells that only read it and provide copies of the Hasaka protein for the Corona-Sarsr-2.This enables the natural immune system of the body to cause a response when they received the vaccine if they are exposed to the virus at a later time.
Q: How long will it provide vaccination against the Cofide-19 virus protection for immunized people?
A: We do not yet know the duration of the continuation of the protection provided by any of these vaccines.We will get better information during the next twelve months.
What is the reason for this large number of candidate vaccines?
A: With the speed of the danger of the pandemic globally, developing effective vaccines Kovid-19 has become the top priority of many pharmaceutical products and medical research institutes.An unprecedented investment of governments and the private sector also occurred in the development of vaccines.There is now a wide range of technologies to develop new vaccines - and many organizations that develop Corona -19 vaccines have special experience in one or more of these technologies.This ensures the continued availability of vaccines if some of them are not approved for reasons related to effectiveness, secure, or manufacturing challenges.
Q: What if a large number of people begin to appear to reaction to a certain vaccine of Kovid-19 vaccines?
A: Reactions in the short term, such as pain in the position of injection, fatigue, or headache, are common after any vaccination with Coveet-19 vaccines. These reactions usually end within a day or two. If new evidence is available indicating the possibility of a certain serious timing event with a specific vaccine from the Kofid-19 vaccines, the organizational authorities will take the necessary measures, and will work cooperatively at the global level and will communicate with the public health authorities. The type of measures that can be taken depends on the nature of the fierce event, and it can range from issuing warnings related to patients for patients, health care professionals and local communities; And updating information about the product or information provided to the consumer of the vaccine to show the contraindications in certain patients (such as those who suffer from certain accompanying diseases); And monitoring the events in certain groups of patients closely; Preventing the distribution of a specific batch of the vaccine, and it comes to the temporary suspension of the use of the vaccine until you know more.
Q: How does the regulatory authorities accelerate the time it takes to declare a vaccine against Kofid-19?
A: Several regulatory authorities have carried out faster tracks to obtain Kovid-19 vaccines, without prejudice to the strict standards of safe, quality and effective.
Q: Did our country agree to the Kofid-19 vaccine, or are we dependent on the approval of another country?
A: The majority of the two countries are conducting independent regulatory assessments of the data provided for each vaccine.However, to ensure the use of resources and expertise more efficiently, the organizational authorities in various countries are closely communicating with the imams, effectiveness and quality data and discussing technical issues as soon as they are established.In many cases, the organization's principles on good accreditation and cooperative mechanisms enhance the outcomes of other organizational powers.
Q: Why was the occurrence of very rare blood clots with platelet deficiency due to the Astrazinica and Yansen whatever during clinical trials?
A: Covering thrombosis with platelet deficiency is very rare - as estimates based on a number of automatic reports indicate that there will be between 10 and 15 cases per million doses.The clinical trials of these vaccines included large numbers of people, often ranged between 10,000 and 20,000 people in the active vaccine arms, but even in experiments of this size, it was unlikely to be statistically unlikely that such very rare events were discovered.This shows the importance of continuous monitoring of the imams while using these vaccines, to allow the disclosure of very rare events and continue to investigate them.
About the International Coalition of Pharmaceutical Authorities
The coalition includes the heads of 30 drug regulations* from all over the world, with the World Health Organization as an observer.The drug regulation authorities are aware of their role in facilitating access to medical products necessary for human health and health, which are safe, effective and high quality.This includes ensuring that the benefits of vaccines exceed their risks.
The coalition is an international body at the executive level consisting of the main organizational authorities from all over the world.It provides a global strategic focus for drug regulation authorities, and provides strategic leadership on common organizational issues and challenges.Its priorities include coordination of response to crisis situations.
The coalition members include: therapeutic commodity management (TGA), Australia; National Health Surveillance (AnVisa), Brazil; Health and Food Products Branch, Canadian Ministry of Health (HPFB-HC), Canada; The Chinese National Administration of Medical Products (NMPA), China, European Pharmaceutical Agency (EMA), European Commission - General Directorate of Health and Food Safety (DG - Sante), European Union; The French National Agency for Safety of Medicines and Health Products (ANSM), France; Paul Erlich Institute (PEI), Germany; Health Products Regulatory Authority (HPRA), Ireland; Italian Agency for Medicines (AIFA), Italy; Ministry of Health, Labor and Social Welfare (MHLW), Medicines and Medical Devices Agency (PMDA), Japan; The Ministry of Food and Drug Safety, Korea; The Federal Committee for the Protection of Health Risk (Cofepris), Mexico; Medicines Evaluation Council (MEB), Netherlands; New Zealand Safety Authority for Medicines and Medical Devices (MedSafe), Clinical Driving, Protection and Organization, Ministry of Health, New Zealand; The National Agency for Medicines and Food Management (NAFDAC), Nigeria; Health Sciences Authority (HSA), Singapore; Medicines Control Council (MCC), South Africa; Medical Products Agency, Sweden; The Swiss Agency for Therapeutic Products, Switzerland; Agency for Medicines and Health Care Products (MHRA), UK; Food and Drug Administration (FDA), United States.
It includes the affiliated members: the Argentine National Administration for Medicines, Food and Medical Devices (AnMAT); Austrian Agency for Medicines and Medical Devices (AIS); The Colombian National Institute for Food and Drug Control (Invima); Cuba Government Control Center on Medicines, Equipment and Medical Devices (CECMED); Danish Pharmaceutical Agency (DKMA); The Israeli Ministry of Health; The Ministry of Health Poland Office for Medical Products Registration and Biological Products (URPLWMIPB); Portuguese National Authority for Medicines and Health Products (Infarmed); The Russian Federal Service for Health Care (Roszdravnadzor); The Food and Drug General Authority in the Kingdom of Saudi Arabia; Spanish Agency for Medicines and Medical Devices (AEMPS)
The pleasure of the World Health Organization
The World Health Organization is under public health leadership within the United Nations system.The organization, which was established in 1948, works with 194 countries in six regions through more than 149 offices, to promote health, maintain the safety of the world and serve the weak.Our goal in the period 2019-2023 is to ensure the benefit of another billion people from comprehensive health coverage, the protection of another billion people from health emergencies, and to ensure that another billion people enjoy more health and wellness