Operation Warp Speed
What is Operation Warp Speed?
The Department of Health and Human Services and the Department of Defense partnered to establish Operation Warp Speed. The purpose of this effort is to quickly generate and distribute millions of COVID-19 vaccine doses, while making sure that the vaccines are safe and effective.
What planning has been done for COVID-19 vaccine distribution?
The plan is for the federal government to host a centralized system to obtain, disburse, and record vaccines. The CDC will order all vaccines. Vaccine administrators will receive shipments of vaccines either directly from a vaccine manufacturer or from the CDC’s centralized system.
There are many vaccines at different levels of development and manufacturing. Two vaccines have been emergency approved and are being distributed. The steps of vaccine distribution include:
- Implementing and testing logistics plans with businesses partnering with the CDC’s centralized system
- Distributing vaccines and associated supplies from central locations to the rest of the country
- Ordering additional vaccine doses
- Receiving and storing vaccines at their required temperatures
- Deciding how vaccines should be distributed
- Safely administering vaccines
- Tracking vaccine stock, administration, and safety
- Increasing and establishing safety surveillance programs
- Creating procedures and methods to determine and report vaccine efficacy
- Communicating with the public and with stakeholders regarding all facets of the COVID-19 vaccination program
The overall goal of the federal government is to secure sufficient COVID-19 vaccine doses for all residents in the United States who want to be vaccinated. A safe and effective vaccine is key to reduce the burden of COVID-19 disease in the United States.
Does the CDC have partners to distribute the COVID-19 vaccines?
The CDC has worked with state, tribal, territorial, and local jurisdictions on vaccination programs and released a playbook on September 16, 2020 that was updated on October 30, 2020.
The CDC has collaborated with private partners and federal agencies on implementing effective vaccination plans. Private partners include pharmacies, such as those offering vaccination to residents in long-term care facilities. Federal agencies include the Indian Health Service.
Has the CDC implemented a national campaign to address any concerns people may have about getting a COVID-19 vaccine?
No. Although there is not a national campaign regarding COVID-19, the CDC does follow the Vaccinate with Confidence guidance which addresses vaccine hesitancy, preventing disease outbreaks in the U.S, and effectively communicating with members of the public and health care providers.
The Vaccinate with Confidence guidance is being tailored to specific issues arising from the COVID-19 pandemic and will be provided to members of the community and health care workers.
What is the CDC doing to ensure that people want to and are able to get vaccinated once a COVID-19 vaccine is available?
The CDC is taking several steps to safely vaccinate United States residents. Important steps include:
- Routinely communicating accurate and coherent data so that people are able to understand the positive and negative aspects of vaccination
- Supporting health care workers in getting the vaccine
- Presenting information so that health care providers can answer questions their patients may have about the vaccine
- Partnering with communities and individuals fairly and equitable so that people can ask questions and obtain accurate date regarding the COVID-19 vaccines
- Providing straightforward access to vaccines
- Reducing or eliminated the costs associated with a vaccine
How can I prevent myself from getting COVID-19 since a vaccine is not yet available?
You should practice physical distancing by staying 6 feet away from other people, avoid people who are sick, avoid crowds, wash your hands with soap and water, and cover your nose and mouth with a mask.
Should I still wear a mask once I receive a COVID-19 vaccine?
Yes. According to the CDC, you should wear a mask to cover your nose and mouth when in contact with people outside your home and when receiving any vaccine. People who cannot breathe or who cannot remove their masks without help should not wear a mask.
Why do we need a vaccine? Don’t other measures, like social distancing and wearing masks, prevent the virus that causes COVID-19 from spreading?
Vaccines help your immune system defend you from disease. It’s important to keep using measures like social distancing and wearing masks to reduce your risk of exposure to the virus and spreading it to others. Additionally, it will take at least several months to vaccinate millions of people in the United States.
Do I still need to wear a mask and keep social distancing if I have received both doses of the vaccine?
Yes. Additional studies are needed to determine how long protection from the vaccines will last and if you can still infect others after receiving two doses of the Pfizer or Moderna vaccine. Until more information is available, you should keep social distancing and use a face mask to reduce your risk of contracting COVID-19 and spreading the virus to other people.
When can I stop wearing a mask and avoiding close contact with other people once I have been vaccinated?
There is not enough information to estimate when the CDC will recommend that measures no longer have to be followed. Studies are ongoing and information will be provided to the public when possible. Additional components affecting the CDC’s recommendations include the number of people who get vaccinated and how the virus spreads within communities.
Does immunity after getting COVID-19 last longer than protection from COVID-19 vaccines?
When you get sick, you acquire natural immunity, meaning you’re protected against that disease for a certain period of time. This natural immunity is dependent on the disease and person. COVID-19 is a relatively new disease, so we don’t know how long natural immunity will last.
Some reports suggest that natural immunity may not last long. Scientists are obtaining additional information on how long natural immunity lasts. Additional data is also being obtained on how long vaccine-induced immunity will last.
What population percentage must get vaccinated so that we can have herd immunity for COVID-19?
Experts currently do not know what percentage of the population must be required to achieve herd immunity, a term which refers to sufficient people having protection against COVID-19 to protect non-immune people within the community from COVID-19. This protection can come from either natural immunity or vaccine-induced immunity. The percentage of the population who must be immune so that herd immunity can be reached is different for each disease.
How do I report it if I have a severe reaction or side effect after getting a COVID-19 vaccine?
The CDC and FDA promote the use of the national Vaccine Adverse Event Reporting System, a system where serious side effects or adverse events are reported and tracked. Vaccine safety is critical.
Health care providers are mandated to report specific adverse events after vaccine administration to VAERS. If the FDA modifies any safety reporting requirements during its Emergency Use Authorization, health care providers must also follow these requirements, which are listed on the FDA’s website.
The CDC is executing a smartphone application (app) termed v-safe. This app allows you to record any side effects or adverse events after receiving a vaccine for COVID-19.
What does it mean if a vaccine clinical trial is interrupted or temporarily paused?
The foremost concern of vaccination studies is safety. Sometimes, clinical trials are paused when an adverse event is identified. This pause allows scientists and doctors to identify the cause or causes of the safety issue and to determine if the clinical trial should continue.
How many COVID-19 vaccines are under being developed?
As of November 24, 2020, there were 5 Phase 3 clinical trials in progress or in preparation in the United States.
Why is it taking so long to create a COVID-19 vaccine? It only took a few months for the H1N1 influenza vaccine to be created.
Vaccine manufacturers can use the same methods for the yearly flu vaccine to create vaccines against newly identified flu strains, such as the 2009 H1N1 strain. Using the same methods saves a substantial amount of time and resources. However, there have not been any vaccines against coronaviruses and COVID-19 is a newly discovered virus, so additional research is needed to create a vaccine specifically for COVID-19.
How do the Pfizer and Moderna vaccines work against COVID-19?
Neither the Pfizer nor the Moderna vaccine contain the COVID-19 virus. Both of these vaccines help you make antibodies to a protein that is located on the surface of the COVID-19 virus. This means that if you come into contact with the virus, your immune system is able to recognize the virus, attack it, and fight off infection.
Is the COVID-19 vaccine a live vaccine? Does it contain the live virus?
No. Neither the Pfizer nor the Moderna vaccine contain any form of the virus—neither live, attenuated, nor inactivated vaccines. They only contain the gene for a viral protein. This means that these vaccines will not infect you with COVID-19.
What is in the COVID-19 vaccine?
COVID-19 virus is not in the Pfizer or the Moderna vaccine. It includes messenger RNA and lipids. The main ingredients or components are:
- The nucleoside-modified messenger ribonucleic acid (termed modRNA) encodes the viral spike protein of SARS-CoV-2.
- Salts act as pH buffers
- Sugar (specifically sucrose)
- Four types of lipids, including PEG
- Polyethylene glycol (PEG) – This lipid is commonly used in laxatives and in patient bowel preparation before colonoscopy procedures. It is the most likely vaccine component that could cause allergic reaction symptoms.
The Pfizer and the Moderna vaccines do not contain any mercury, thimerosal, antibiotics, or preservatives.
Are COVID-19 vaccines proven to be safe?
The FDA is responsible for evaluating safety information of any vaccine used in the United States. Vaccines must be both safe and effective to be approved. They must undergo meticulous preclinical and clinical testing before they can be approved.
How can a vaccine be made so quickly?
Usually, it takes years to develop vaccines. Previous coronavirus outbreaks, including SARS (Severe Acute Respiratory Syndrome) in 2003 and MERS (Middle East Respiratory Syndrome) in 2012 have prompted research into vaccines specifically targeting coronaviruses. Scientists had already made important research discoveries which were then used to create the 2020 Pfizer and Moderna vaccines against SARS-CoV2, which is the name of the virus that leads to COVID-19.
What are the side effects of the COVID-19 vaccine?
All medications or vaccines can lead to side effects. Usually, these side effects are relatively minor, such as a sore arm where the vaccine was injected or a low-grade fever. Side effects usually only last a few days and do not lead to long-term consequences.
COVID-19 vaccines are only approved by the FDA when data from clinical trials shows that they are both safe and effective. No serious side effects have been observed with the Pfizer or the Moderna vaccine.
What is an Emergency Use Authorization?
An Emergency Use Authorization (EUA) is a special designation issued by the FDA if an unapproved medical product or a different use of a medical product is used in the event of an emergency, such as the COVID-19 pandemic. The purpose of this authorization is to diagnose, treat, or prevent disease in cases where no treatments exist. In the case of COVID-19, no preventative vaccines existed before the Pfizer and Moderna vaccines were granted an EUA.
Companies must submit a request which is reviewed by the FDA. If granted, the product or device can then be used for a specific purpose.
Who can get the vaccine?
The Centers for Disease Control (CDC) and the South Carolina COVID-19 Vaccine Advisory Committee (VAC) have made recommendations on the distribution of COVID-19 vaccines. Currently, South Carolina is in Phase 1a—the underlying goal of the VAC and this phase is to prevent as many deaths as possible. People in this category include patient-facing medical workers and long-term care facility staff and residents. People in this category have preferred access to vaccines before people in any other category.
Additional vaccines will undergo FDA authorization and possible approval. As additional vaccines undergo this process and more vaccines are produced and distributed, COVID-19 vaccines will be available for everyone. In the coming months, we will have greater vaccine availability.
How will I know when I will be able to get the vaccine?
Federal government and California have plans in place to notify the public of vaccine availability. These plans include notifications via news releases, website updates, and social media updates. Public service announcements will include print, radio, TV ads, mailers, and community-level outreach information efforts. These sources of information will include how residents will obtain their vaccine. Health care providers will also alert patients regarding vaccine availability. They ill not be registering residents on a list.
How much will it cost to get vaccinated with a COVID-19 vaccine?
The vaccine cost will be covered by the federal government, meaning no out-of-pocket costs for individuals. Vaccine administration will be covered by Medicare, Medicaid, and private insurers. Some health care providers may charge for an office visit or for vaccine administration. The Health Resources and Services Administration’s Provider Relief Fund will cover administrative costs for uninsured people receiving the vaccine.
How will the Pfizer and Moderna COVID-19 vaccines be administered?
The Pfizer and Moderna vaccines are administered by an injection into the muscle of the arm, termed an intramuscular injection. Two doses are required for each vaccine.
Will more than one dose of COVID-19 vaccine be required?
The Pfizer-BioNTech vaccine and the Moderna vaccine both require two doses. The Pfizer vaccine doses require an interval of 21 days between doses while the Moderna vaccine requires an interval of 28 days. You will receive a second dose of the same company’s vaccine, meaning if your first dose was a Pfizer vaccine, your second dose will also be a Pfizer vaccine.
How will I know when I need to get my second dose?
You will receive a physical (paper) immunization record at the time of your first vaccination. This record will detail the type of vaccine you received, date, location, and the date of your next vaccine. You will be reminded of your next vaccine date by your health care provider.
The brand of vaccine you receive, when you receive it, and the date of your second dose, are confidential health information. Your information will be protected to maintain your privacy.
Will people who have already had COVID-19 be able to get the vaccine?
Yes. People who have been previously infected with COVID-19 should receive the vaccine. The CDC notes that people are able to be reinfected approximately 90 days after infection.
Reinfection is rare within the first 90 days of the onset of COVID-19 symptoms. According to DHEC, if people are eligible for the vaccine in phase 1a but had COVID-19, these people should consider delaying their vaccination. This delay will allow other, more vulnerable people, to be vaccinated.
Can I get more than one COVID-19 vaccine?
No. Current recommendations are to receive only one type of vaccine as the administration of different brands has not been tested and safety data remains unknown. When receiving several doses of the vaccine, such as is the case with Pfizer and Moderna vaccines, both doses should be provided by the same company.
Is the vaccine safe for women who are pregnant?
Pregnant women are not included in vaccine clinical trials. The Pfizer and Moderna vaccines have not yet been tested in pregnant women. These two mRNA vaccines do not contain a live virus, but instead lead your immune system to generate antibodies against a protein found on the surface of the coronavirus.
In theory, mRNA vaccines should not harm a fetus. As more information regarding vaccine safety for pregnant women emerges, vaccine guidelines will be updated. According to the Society for Fetal and Maternal Medicine, healthcare workers who fall into the phase 1a category should be offered the vaccine if pregnant.
When and how will people who are considered high risk get the vaccine?
The first phase of vaccination will include people working in health care settings who are at risk of contracting COVID-19 and people with medical conditions that put them at risk of contracting severe COVID-19 infection.
Vaccination will be available through pharmacies, hospitals, health care providers, and community clinics.
Information regarding vaccine availability will be conveyed by via public service announcements, website updates, media briefings, letters to doctors, and other methods.
Vaccine Planning, Shipping and Storage
Can any pharmacy or clinic provide the COVID-19 vaccine?
In order to obtain and administer a vaccine against COVID-19, health care providers must be enrolled in a federal vaccine distribution plan. Some national chains are able to directly register with the Centers for Disease Control (CDC). The federal government disburses vaccines and accompanying supplies without charge to the enrolled providers.
Both Walgreen’s and CVS Pharmacies have already been directly enrolled into the COVID-19 vaccination program with the CDC. These pharmacies will receive vaccines to administer to California residents and people working in long-term health care facilities.
What are the storage and handling requirements for the COVID-19 vaccines?
Both the Pfizer and Moderna vaccines must be kept refrigerated or frozen, ranging in temperatures between -90° C and 8° C throughout their storage and transport. The manufacturers of these vaccines are in the process of testing the temperatures at which the vaccines remain stable and will notify the relevant federal and state organizations.
Training materials and information regarding the storage and handling of COVID-19 vaccines is being developed and will be communicated to health care providers.
Will there be a required observation period after vaccination?
After vaccine administration, patients should be observed in a health care facility by health care providers for approximately 15 minutes. In drive-through vaccination programs, there should be sufficient parking for this post-vaccination observation to take place.
Is there guidance for administering vaccines in a setting other than a doctor’s office (e.g., pharmacies; temporary, off-site, or satellite clinics; and large-scale influenza clinics)?
Yes. Specific guidelines have been developed for satellite clinics, pharmacies, temporary settings, and large-scale clinics. In addition to these vaccine administrations sites, drive-through sites, curbside clinics, mobile clinics, and homesite visits may be utilized to administer vaccines. Local Public Health will provide additional information.
General principles for health care facilities should be employed in the case of alternative sites, including physical distancing. These principles include:
- Scheduling specific appointment times to avoid unnecessary physical crowding of patients and efficiently vaccinating patients
- Securing adequate resources and staff to administer vaccines to patients in a safe and effective manner
- Reducing the overall number of patients at the vaccine administration site, especially in the case of high-risk patient populations
What is the recommendation for receiving flu vaccine this fall and winter with the ongoing COVID-19 pandemic?
DHEC and the CDC recommends that children and adults who are older than six months should receive an influenza or flu vaccine each year.
During the COVID-19 pandemic, it is especially important to reduce the health care burden of respiratory diseases. Vulnerable populations are at a higher risk of severe COVID-19. Administering the flu vaccine will reduce hospitalizations; health care providers should encourage flu vaccines whenever possible.
Can other vaccines, including flu vaccines, be administered at the same time as the COVID-19 vaccines?
According to the General Best Practice Guidelines for Immunizations an inactivated vaccine can be injected at the same time or after a separate inactivated or live vaccine.
If possible, receiving the COVID-19 Pfizer or Moderna vaccine separately from other vaccines unless necessary. This is because recipients of the COVID-19 vaccine might experience uncomfortable temporary symptoms including fatigue, muscle aches, or a fever. These symptoms range from mild to moderate.
Should flu vaccines be given to someone with suspected or confirmed COVID-19?
No. In the event that a person is suspected or confirmed to have COVID-19, vaccination should be delayed, even if the person is asymptomatic. Vaccination can take place after self-isolation.
Lots of options neatly organized into sections that allows you to build website without any coding knowledge. Please take some time and navigate through each option tab, most things are self explained. Go to Cosgrove Options to start. Don’t forget to click on Save All Changes to save your settings once you are finished.A mild case of COVID-19 is not a contraindication to receiving either the Pfizer or Moderna vaccine. However, postponing the vaccination of people with COVID-19 will reduce the burden on health care workers and other patients. Patients should be instructed to contact their health care provider before their vaccination should they have or develop any symptoms of COVID-19.
People who were previously sick with either COVID-19 or the flu are not protected against the flu. Yearly flu vaccination is recommended.
Are there any contraindications with providing COVID-19 vaccine while someone is being treated with antivirals for influenza?
People who are allergic to the Pfizer or the Moderna vaccine’s components or who have experienced anaphylaxis or a serious allergic reaction to another vaccine or injection (whether subcutaneous, intramuscular, or intravenous) are contraindicated against the COVID-19 vaccine.
Currently, no contraindications or interactions are known in instances where patients receive antiviral treatments for influenza. However, this has not been tested in Phase 3 clinical trials.
Is there guidance for safely administering vaccines during the COVID-19 pandemic?
Yes. The CDC has announced its Interim Guidance for Immunization Services During the COVID-19 Pandemic. These guidelines help vaccination or immunization providers in health care settings to safely vaccinate residents during the COVID-19 pandemic. Guidelines will continue to be updated as epidemiological results relating to COVID-19 within the United States are circulated.
Are there specific infection control procedures to follow when administering vaccines during a pandemic?
Infection prevention protocols should be implemented as health care providers administer COVID-19 vaccines. Infection prevention strategies include physical distancing, surface decontamination, source control, and respiratory and hand hygiene.
The CDC’s General Practices for Safe Delivery of Vaccination Services details these recommendations. The Immunization Action Coalition has released a guide: Protective Measures for Vaccinating During the Pandemic detailing PPE, signage, and patient management.
Will the COVID-19 vaccine be mandatory for health care providers?
Individual facilities will determine whether or not they require the COVID-19 vaccine, as is the case in flu vaccine requirements. CDC recommends that health care workers interacting with COVID-19 patients or workers at high risk of severe COVID-19 (including people who work in long-term care facilities) receive the COVID-19 vaccine.
How does body find against infection?
To understand how COVID-19 vaccines work, it helps to first look at how our bodies fight illness. When germs, such as the virus that causes COVID-19, invade our bodies, they attack and multiply. This invasion, called an infection, is what causes illness. Our immune system uses several tools to fight infection. Blood contains red cells, which carry oxygen to tissues and organs, and white or immune cells, which fight infection. Different types of white blood cells fight infection in different ways:
- Macrophages are white blood cells that swallow up and digest germs and dead or dying cells. The macrophages leave behind parts of the invading germs called antigens. The body identifies antigens as dangerous and stimulates antibodies to attack them.
- B-lymphocytes are defensive white blood cells. They produce antibodies that attack the pieces of the virus left behind by the macrophages.
- T-lymphocytes are another type of defensive white blood cell. They attack cells in the body that have already been infected.
The first time a person is infected with the virus that causes COVID-19, it can take several days or weeks for their body to make and use all the germ-fighting tools needed to get over the infection. After the infection, the person’s immune system remembers what it learned about how to protect the body against that disease.
The body keeps a few T-lymphocytes, called memory cells, that go into action quickly if the body encounters the same virus again. When the familiar antigens are detected, B-lymphocytes produce antibodies to attack them. Experts are still learning how long these memory cells protect a person against the virus that causes COVID-19.
How does COVID-19 Vaccines Work?
COVID-19 vaccines help our bodies develop immunity to the virus that causes COVID-19 without us having to get the illness. Different types of vaccines work in different ways to offer protection, but with all types of vaccines, the body is left with a supply of “memory” T-lymphocytes as well as B-lymphocytes that will remember how to fight that virus in the future.
It typically takes a few weeks for the body to produce T-lymphocytes and B-lymphocytes after vaccination. Therefore, it is possible that a person could be infected with the virus that causes COVID-19 just before or just after vaccination and then get sick because the vaccine did not have enough time to provide protection.
Sometimes after vaccination, the process of building immunity can cause symptoms, such as fever. These symptoms are normal and are a sign that the body is building immunity.
What are the different types of Vaccines ?
Currently, there are three main types of COVID-19 vaccines that are or soon will be undergoing large-scale (Phase 3) clinical trials in the United States. Below is a description of how each type of vaccine prompts our bodies to recognize and protect us from the virus that causes COVID-19. None of these vaccines can give you COVID-19.
- mRNA vaccines contain material from the virus that causes COVID-19 that gives our cells instructions for how to make a harmless protein that is unique to the virus. After our cells make copies of the protein, they destroy the genetic material from the vaccine. Our bodies recognize that the protein should not be there and build T-lymphocytes and B-lymphocytes that will remember how to fight the virus that causes COVID-19 if we are infected in the future.
- Protein subunit vaccines include harmless pieces (proteins) of the virus that cause COVID-19 instead of the entire germ. Once vaccinated, our immune system recognizes that the proteins don’t belong in the body and begins making T-lymphocytes and antibodies. If we are ever infected in the future, memory cells will recognize and fight the virus.
- Vector vaccines contain a weakened version of a live virus—a different virus than the one that causes COVID-19—that has genetic material from the virus that causes COVID-19 inserted in it (this is called a viral vector). Once the viral vector is inside our cells, the genetic material gives cells instructions to make a protein that is unique to the virus that causes COVID-19. Using these instructions, our cells make copies of the protein. This prompts our bodies to build T-lymphocytes and B-lymphocytes that will remember how to fight that virus if we are infected in the future.
COVID-19 Vaccines Require More Than One Shot ?
All but one of the COVID-19 vaccines that are currently in Phase 3 clinical trials in the United States use two shots. The first shot starts building protection. A second shot a few weeks later is needed to get the most protection the vaccine has to offer. One vaccine in Phase 3 clinical trials only needs one shot.
What are some of the side effects in early clinical trials ?
Mild Side Effects Among All Study Participants*
Injection Site Reactions Fatigue Chills Muscle Pain Joint Pain Headaches Moderna 91.6% 68.5% 43.4% 59.6% 44.8% 63% Pfizer-BioNTech 84.10% 62.90% 31.90% 38.30% 23.60% 55.10%
Issues with Pregnancy and the COVID 19 Vaccine:
Safety Data :
Available Safety Information Related to the use of COVID-19 Vaccines in Pregnancy
Despite ACOG’s ( American college of Obstretics and Gynecology) persistent advocacy for the inclusion of pregnant individuals in COVID-19 vaccine trials, none of the COVID-19 vaccines approved under EUA have been tested in pregnant individuals. However, studies in pregnant women are planned.
Data from Developmental and Reproductive Toxicity (DART) studies for the Pfizer-BioNtech COVID-19 vaccine are anticipated in mid-December, according to the manufacturer. From what has been communicated so far regarding these forthcoming data, there have not been any major safety signals identified.
A combined developmental and perinatal/postnatal reproductive toxicity (DART) study of Moderna’s mRNA-1273 in rats was submitted to FDA on December 4, 2020. FDA review of this study concluded that mRNA1273 given prior to mating and during gestation periods at dose of 100 µg did not have any adverse effects on female reproduction, fetal/embryonal development, or postnatal developmental except for skeletal variations which are common and typically resolve postnatally without intervention (FDA).
These DART studies provide the first safety data to help inform the use of the vaccine in pregnancy until there are more data in this population.
Among participants of Phase II/III COVID-19 vaccine clinical studies in non-pregnant adults, a few inadvertent pregnancies that have occurred are being followed to collect safety outcomes.
ACOG ( American college of Obstetrics and Gynecology ) Recommendations
ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on ACIP-recommended priority groups. While safety data on the use of COVID-19 vaccines in pregnancy are not currently available, there are also no data to indicate that the vaccines should be contraindicated, and no safety signals were generated from DART studies for the Pfizer-BioNtech and Moderna COVID-19 vaccines. Therefore, in the interest of allowing pregnant individuals who would otherwise be considered a priority population for vaccines approved for use under Emergency Use Authorization (EUA) to make their own decisions regarding their health, ACOG recommends that pregnant individuals should be free to make their own decision in conjunction with their clinical care team.
Individuals considering a COVID-19 vaccine should have access to available information about the safety and efficacy of the vaccine, including information about data that are not available. A conversation between the patient and their clinical team may assist with decisions regarding the use of vaccines approved under EUA for the prevention of COVID-19 by pregnant patients. Important considerations include the level of activity of the pandemic in the community, the potential efficacy of the vaccine, the potential risk and severity of maternal disease, including the effects of disease on the fetus and newborn, and the safety of the vaccine for the pregnant patient and the fetus. While a conversation with a clinician may be helpful, it should not be required prior to vaccination as this may cause unnecessary barriers to access.
Clinicians should review the available data on risks and benefits of vaccination with pregnant patients, including the risks of not getting vaccinated in the context of the individual patient’s current health status, and risk of exposure, including the possibility for exposure at work or home and the possibility for exposing high-risk household members. Conversations about risk should take into account the individual patient’s values and perceived risk of various outcomes and should respect and support autonomous decision-making (ACOG 2013).
- Pregnant women who experience fever following vaccination should be counseled to take acetaminophen. Acetaminophen has been proven to be safe for use in pregnancy and does not appear to impact antibody response to COVID-19 vaccines.
- There is currently no preference for the use of one COVID-19 vaccine over another except for 16-17 year olds who are only eligible for the Pfizer-BioNtech vaccine.
- Individuals should complete their 2-dose series with the same vaccine product.
- COVID-19 vaccines should not be administered within 14 days of receipt of another vaccine. For pregnant individuals, vaccines including Tdap and influenza should be deferred for 14 days after the administration of COVID-19 vaccines.
- Anti-D immunoglobulin (i.e. Rhogam) should not be withheld from an individual who is planning or has recently received a COVID-19 vaccine as it will not interfere with the immune response to the vaccine.
Pregnant patients who decline vaccination should be supported in their decision. Regardless of their decision to receive or not receive the vaccine, these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask.
Pregnant individuals who receive a COVID-19 vaccine should be educated about and encouraged to participate in CDC’s V-SAFE program (see more information on CDC’s V-SAFE program).
ACOG recommends COVID-19 vaccines be offered to lactating individuals similar to non-lactating individuals when they meet criteria for receipt of the vaccine based on prioritization groups outlined by the ACIP. While lactating individuals were not included in most clinical trials, COVID-19 vaccines should not be withheld from lactating individuals who otherwise meet criteria for vaccination. Theoretical concerns regarding the safety of vaccinating lactating individuals do not outweigh the potential benefits of receiving the vaccine. There is no need to avoid initiation or discontinue breastfeeding in patients who receive a COVID-19 vaccine (ABM 2020).
Individuals Contemplating Pregnancy
Vaccination is strongly encouraged for non-pregnant individuals within the ACIP prioritization group(s). Further, ACOG recommends vaccination of individuals who are actively trying to become pregnant or are contemplating pregnancy and meet the criteria for vaccination based on ACIP prioritization recommendations. Additionally, it is not necessary to delay pregnancy after completing both doses of the COVID-19 vaccine.
Given the mechanism of action and the safety profile of the vaccine in non-pregnant individuals, COVID-19 mRNA vaccines are not thought to cause an increased risk of infertility.
If an individual becomes pregnant after the first dose of the COVID-19 vaccine series, the second dose should be administered as indicated. If an individual receives a COVID-19 vaccine and becomes pregnant within 30 days of receipt of the vaccine, participation in CDC’s V-SAFE program should be encouraged.
Importantly, routine pregnancy testing is not recommended prior to receiving any EUA-approved COVID-19 vaccine.