>>52575

medlineplus.gov

COVID-19 Vaccine (Moderna): MedlinePlus Drug Information

Moderna coronavirus disease 2019 (COVID-19) vaccine is currently being studied to prevent coronavirus disease 2019 caused by the SARS-CoV-2 virus.There is no FDA-approved vaccine to prevent COVID-19.

Some clinical trial information is available at this time to support the use of Moderna COVID-19 vaccine to prevent COVID-19. In clinical trials, approximately 15,400 individuals 18 years of age and older have received at least 1 dose of the Moderna COVID-19 vaccine. More information is needed to know how well Moderna COVID-19 vaccine works to prevent COVID-19 and the possible adverse events from it.

Moderna COVID-19 vaccine has not undergone the standard review to be approved by the FDA for use. However, the FDA has approved an Emergency Use Authorization (EUA) to allow people 18 years of age and older to receive it.

Talk to your doctor about the risks and benefits of receiving this medication.

COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory (lung) illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever, chills, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea.

The Moderna COVID-19 vaccine will be given to you as an injection into the muscle. The Moderna COVID-19 vaccine vaccination series is 2 doses given 1 month apart. If you receive one dose of the Moderna COVID-19 vaccine, you should receive a second dose of this same vaccine 1 month later to complete the vaccination series.

Tell your vaccine provider about all of your medical conditions, including if you:

have any allergies.

have a fever.

have a bleeding disorder or are on a blood thinner such as warfarin (Coumadin, Jantoven).

have a weakened immune system or are on a medicine that affects your immune system.

are pregnant or plan to become pregnant.

are breastfeeding.

have received another COVID-19 vaccine.

have had a severe allergic reaction after a previous dose of this vaccine.

have had a serious allergic reaction to any ingredient in this vaccine.

Side effects that have been reported with the Moderna COVID-19 vaccine include:

injection site pain, swelling, and redness

tenderness and swelling of lymph nodes (in the same arm where you got the injection)

tiredness

headache

muscle pain

joint pain

chills

nausea

vomiting

fever

There is a remote chance that the Moderna COVID-19 vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Moderna COVID-19 vaccine.

Signs of a severe allergic reaction can include:

difficulty breathing

swelling of your face and throat

a fast heartbeat

a bad rash all over your body

dizziness and weakness

cont…

Last Revised - 01/15/2021

https://medlineplus.gov/druginfo/meds/a621002.html#other-name

>>52576

COVID-19 Vaccine (Moderna): MedlinePlus Drug Information

cont…

These may not be all the possible side effects of the Moderna COVID-19 vaccine. Serious and unexpected side effects may occur. Moderna COVID-19 vaccine is still being studied in clinical trials.

If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include "Moderna COVID-19 Vaccine EUA" in the first line of box #18 of the report form.

In addition, you can report side effects to ModernaTX, Inc. at 1-866-663-3762.

You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: http://www.cdc.gov/vsafe.

No. The Moderna COVID-19 vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

When you get your first dose, you will get a vaccination card to show you when to return for your second dose of Moderna COVID-19 vaccine. Remember to bring your card when you return.

The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for the second dose. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one year from the date of receiving the vaccine. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427.

The American Society of Health-System Pharmacists, Inc. represents that this information about the Moderna COVID-19 vaccine was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that the Moderna COVID-19 vaccine is not an approved vaccine for coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, is being investigated for and is currently available under an FDA emergency use authorization (EUA) to prevent COVID-19 people 18 years of age and older. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information, and specifically disclaims all such warranties. Readers of the information about the Moderna COVID-19 vaccine are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of this information. Readers are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information contained in this information is provided for informational purposes only. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. This information about the Moderna COVID-19 vaccine is not to be considered individual patient advice. Because of the changing nature of drug information, you are advised to consult with your physician or pharmacist about specific clinical use of any and all medications.

mRNA COVID-19 vaccine

mRNA-1273

Last Revised - 01/15/2021

https://medlineplus.gov/druginfo/meds/a621002.html#other-name

>>52576

What is an Emergency Use Authorization (EUA)?

An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.

Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.

Are the COVID-19 vaccines rigorously tested?

Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA.

https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

>>52576

What is an Emergency Use Authorization (EUA)?

thou shalt not commit logical fallacies

Appeal to Emotion - manipulating an emotional response in place of a valid and compelling argument. e.g. name names

Who are the FDA career professionals evaluating EUAs for vaccines?

The FDA staff are career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines intended to prevent infectious diseases. These FDA professionals are committed to decision-making based on scientifically driven evaluation of data. FDA staff are like your family - they are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are also directly impacted by the work that they do, and are exactly who you want making these important public health decisions for the United States.

https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

>>52576, >>52586, >>52590

Contains Nonbinding Recommendations

Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry

IV.NONCLINICAL DATA – KEY CONSIDERATIONS

A.General Considerations

•The purpose of nonclinical studies of a COVID-19 vaccine candidate is to define its immunogenicity and safety characteristics through in vitro and in vivo testing. Nonclinical studies in animal models3F4 help identify potential vaccine related safety risks and guide the selection of dose, dosing regimen, and route of administration to be used in clinical studies. The extent of nonclinical data required to support proceeding to first in human (FIH) clinical trials depends on the vaccine construct, the supportive data available for the construct and data from closely related vaccines.

•Data from studies in animal models administered certain vaccine constructs against other coronaviruses ( SARS-CoV and MERS-CoV) have raised concerns of a theoretical risk for COVID-19 vaccine-associated enhanced respiratory disease (ERD). In these studies, animal models were administered vaccine constructs against other coronaviruses and subsequently challenged with the respective wild-type virus. These studies have shown evidence of immunopathologic lung reactions characteristic of a Th-2 type hypersensitivity similar to ERD described in infants and animals that were administered formalin-inactivated respiratory syncytial virus (RSV) vaccine and that were subsequently challenged with RSV virus due to natural exposure or in the laboratory, respectively (Refs. 4-9).Vaccine candidates should be assessed in light of these studies as described in section D, below.

https://www.fda.gov/media/139638/download

Definition of ERD

Enhanced respiratory disease (ERD) describes severer clinical symptoms after respiratory virus infection, such as with respiratory syncytial virus and influenza virus, due to previous immune responses. ERD usually manifests itself as peribronchiolar monocytic infiltration with an excess of eosinophils.

ERD Research

A typical measles and enhanced respiratory syncytial virus disease (ERD) made simple

Fernando P Polack 1

Affiliations

PMID: 17515829 DOI: 10.1203/PDR.0b013e3180686ce0

Abstract

A typical measles and enhanced respiratory syncytial virus disease (ERD) were serious diseases that resulted from exposure of children immunized with inactivated vaccines against measles virus (MV) and respiratory syncytial virus (RSV) to the respective wild-type agents in the 1960s. Although the clinical manifestations of both illnesses were different, the immune responses elicited and primed for by the vaccines shared important similarities. Both vaccines failed to elicit long-lived protective antibody and to promote cytotoxic T lymphocyte responses. In both cases, post vaccination exposure to wild type virus during community outbreaks was associated with immune complex deposition in affected tissues, vigorous CD4 T lymphocyte proliferative responses, and a Th2 bias of the immune response. No relapses of atypical measles or ERD were ever reported. In this manuscript, the pathogeneses of both enhanced diseases and the requirements for the generation of protective antibodies against MV and RSV are discussed, to contribute to the development of newer safe and effective vaccines against these important pathogens.

Polack FP. Atypical measles and enhanced respiratory syncytial virus disease (ERD) made simple. Pediatr Res. 2007 Jul;62(1):111-5. doi: 10.1203/PDR.0b013e3180686ce0. PMID: 17515829.

https://pubmed.ncbi.nlm.nih.gov/17515829/

>>52576

CDC vaccine claims prior to completion of studies

CDC claims regarding function and efficacy of COVID-19 mRNA vaccine prior to completion of studies

COVID-19 and Your Health

A Closer Look at How COVID-19 mRNA Vaccines Work

New Approach to Vaccines

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 protein—or even just a piece of a protein—that 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.

COVID-19 mRNA vaccines give instructions for our cells to make a harmless piece of what is called the “spike protein.” The spike protein is found on the surface of the virus that causes COVID-19.

COVID-19 mRNA vaccines are given in the upper arm muscle. Once the instructions (mRNA) are inside the immune cells, the cells use them to make the protein piece. After the protein piece is made, the cell breaks down the instructions and gets rid of them.

Next, the cell displays the protein piece on its surface. Our immune systems recognize that the protein doesn’t belong there and begin building an immune response and making antibodies, like what happens in natural infection against COVID-19.

At the end of the process, our bodies have learned how to protect against future infection. The benefit of mRNA vaccines, like all vaccines, is those vaccinated gain this protection without ever having to risk the serious consequences of getting sick with COVID-19.

—-

Facts about COVID-19 mRNA Vaccines

They cannot give someone COVID-19.

mRNA vaccines do not use the live virus that causes COVID-19.

They do not affect or interact with our DNA in any way.

mRNA never enters the nucleus of the cell, which is where our DNA (genetic material) is kept.

The cell breaks down and gets rid of the mRNA soon after it is finished using the instructions.

—-

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html