Getting sick with a newborn in the house can be stressful, especially if youre worried about passing the illness to your baby through close contact or even breast milk.
It might be a relief to know that the virus that causes COVID-19 doesnt pass to your baby through breast milk. However, its still possible to infect your baby if you are sick and providing care to an infant.
This article will discuss the risks and benefits of breastfeeding if youre infected with COVID-19, and how to protect an infant if you are sick with COVID-19.
Breast milk and the act of breastfeeding itself have many benefits for your baby even if you are sick with COVID-19. Numerous studies have analyzed the milk of mothers infected with COVID-19 and found that the virus is not passed through breast milk but antibodies that protect them from infection can be.
As with other viral illnesses, your body begins making antibodies shortly after infection. These antibodies are similar to vaccines in the way they include information to help your body fight the infection.
However, when you breastfeed with a COVID-19 infection, your baby can be infected if other precautions such as washing your hands and wearing a mask are not taken. This is due to face-to-face and hand-to-body contact while breastfeeding, not the breast milk itself.
Although the virus isnt passed through breast milk, its important to remember that you can still infect your baby through regular transmission methods like saliva and respiratory particles.
While your breast milk itself is safe, there are still precautions you should take to avoid transmitting the virus to your baby in other ways. These include:
Pregnant and breastfeeding women are at an increased risk of becoming severely ill with COVID-19, but vaccination is considered safe and is strongly recommended.
The Centers for Disease Control and Prevention (CDC) currently recommends vaccination against COVID-19 for pregnant and nursing mothers, as well as other close caregivers.
In general, CDC recommends pregnant and nursing mothers stay up to date on all vaccinations not just the COVID vaccine except vaccines that contain live virus particles like:
Aside from protecting mothers from becoming severely ill, there is evidence that vaccination can help protect babies, too. Antibodies that offer protection from the virus can be passed through breast milk, whether those antibodies came from a COVID-19 infection itself or from vaccination.
If you are sick with COVID-19, its best to isolate yourself from other members of the household who are not infected including your baby. This means having other members of the household who are well, and ideally vaccinated, take care of the baby while you recover.
When this isnt an option either because you live alone or other household members are also infected, you or other caregivers should wear a mask and practice careful hand hygiene when caring for your baby.
Even household members who are well should wear masks when caring for your infant as long as you are in isolation or ill.
If you or other members of the household are feeling better after having COVID-19, you should continue to wear a mask when caring for your baby until at least the 10th day after you tested positive for COVID-19 or began experiencing symptoms.
One report that tracked mothers infected with COVID-19 who breastfed their babies found that between 2 and 5 percent of infants ended up infected also, but they were either asymptomatic or only mildly sick.
If you suspect your baby has become infected with COVID-19, call your pediatrician for guidance.
No. No particles of virus that cause active infection have been found in breast milk.
Breast milk has been found to contain antibodies to the COVID-19 virus that can help protect your baby from severe infection. This includes antibodies you develop during an active COVID-19 infection or from vaccination.
At this time babies cannot be vaccinated. Children must be at least 5 years old to receive the COVID vaccine.
If you have COVID-19 and have an infant you are breastfeeding, consider expressing milk and allowing someone else who is not infected to feed the baby while you isolate.
If you or someone else who is infected must feed and care for your baby while you have COVID-19, wear a mask and be sure to wash hands for at least 20 seconds before handling the baby or breast milk.
Breast milk is a nutritional and readily available food source for your baby, and it can even provide protective antibodies that can prevent severe infection should COVID be passed to your child.
The virus that causes COVID-19 is not passed through breast milk, but anyone handling a baby still has to be careful to avoid infecting the baby through respiratory particles or close contact.
Researchers from the University of Sheffield and Stanford University say they have discovered that there are specific genetic signals in people who develop severe coronavirus infection.
It is known that age, body mass index, and pre-existing health problems account for some of the disparities, but genetics also plays a significant role. The current study Multiomic analysis reveals cell-type-specific molecular determinants of COVID-19 severity, published in Cell Systems, aimed to address why some people with COVID-19 become seriously ill or die, while others have few, if any, symptoms.
The scientists used a machine learning tool named RefMap, which can find patterns in vast amounts of data, to help identify the genetic basis for complex and poorly understood diseases. The identified more than 1,000 genes linked to the development of severe COVID-19 cases that required breathing support, or were fatal. They were also able to identify specific types of cells in which those genes act up.
The study is one of the first to link coronavirus-associated genes to specific biological functions.
Researchers used several large data sets to unpack the genetics behind severe COVID-19. [Peterschreiber.media/Getty Images]The determinants of severe COVID-19 in healthy adults are poorly understood, which limits the opportunity for early intervention. We present a multiomic analysis using machine learning to characterize the genomic basis of COVID-19 severity. We use single-cell multiome profiling of human lungs to link genetic signals to cell-type-specific functions, write the investigators.
We discover >1,000 risk genes across 19 cell types, which account for 77% of the SNP-based heritability for severe disease. Genetic risk is particularly focused within natural killer (NK) cells and Tcells, placing the dysfunction of these cells upstream of severe disease. Mendelian randomization and single-cell profiling of human NK cells support the role of NK cells and further localize genetic risk to CD56brightNK cells, which are key cytokine producers during the innate immune response. Rare variant analysis confirms the enrichment of severe-disease-associated genetic variation within NK-cell risk genes.
Our study provides insights into the pathogenesis of severe COVID-19 with potential therapeutic targets.
During the research we discovered the genetic architecture underlying coronavirus infection, and found that these 1,000 genes account for three quarters of the genetic drivers for severe COVID-19, said Johnathan Cooper-Knock, PhD, National Institute for Health and Care Research (NIHR) clinical lecturer in the department of neuroscience at the University of Sheffield and co-author of the study. This is significant in understanding why some people have had more severe symptoms of COVID-19 than others.
Michael P. Snyder, PhD, principal investigator in the department of genetics at Stanford, led the study in collaboration Stanford genetics instructor Sai Zhang, PhD, and Cooper-Knock, who is currently a Stanford visiting scholar.
The research team used several large data sets to unpack the genetics behind severe COVID-19. The first data set contained genetic information from healthy human lung tissue. The data helped identify gene expression in 19 different types of lung cells, including epithelial cells that line the respiratory tract and are the first defense against infection.
Other data came from the COVID-19 Host Genetics Initiative, one of the largest genetic studies of critically ill coronavirus patients. The researchers looked for genetic clues in the datasingle nucleotide polymorphismsthat might indicate if someone is at a higher risk for severe COVID-19. They tracked whether some mutations occurred more or less often in COVID-19 patients with severe disease.
Mutations that continued to appear, or were notably absent, in the patients who developed severe COVID-19 suggested those variations might be behind the infections severity.
But genetic mutations on their own can be difficult to interpret. To better understand their findings the team used other data describing which regions of the genome are important for different cell types within lung tissue. By overlapping the mutations onto the cell-specific genomes the researchers could pinpoint which genes were dysfunctioning and within which cell-types.
The researchers also wanted to know which types of cells harbored faulty gene expression. Through their machine learning tool, they determined that severe COVID-19 is largely associated with a weakened response from two well-known immune cells, i.e., natural killer (NK) cells and T cells. NK cells and a subtype called CD56 bright are considered the most important.
NK cells, which humans are born with and are the bodys first line of defense against infection, are known for their ability to destroy viruses and cancer cells, noted Cooper-Knock. NK cells also help produce a range of immune system proteins called cytokines. One cytokine, interferon gamma, is a key activator of immune cells. Acting in concert with interferon gamma, NK cells mount an immediate and coordinated defense against viral infections.
NK cells are like the generals directing the war. They mobilize other immune cells, telling them where to go and what to do. We found that in people with severe coronavirus infection, critical genes in NK cells are expressed less, so theres a less robust immune response. The cell isnt doing what its supposed to do.
Stanfords Snyder likened COVID-19 risk genes to harmful variants of the BRCA genes that predispose some people to breast and ovarian cancer.
Our findings lay the foundation for a genetic test that can predict who is born with an increased risk for severe COVID-19, he said. Imagine there are 1,000 changes in DNA linked to severe COVID-19. If you have 585 of these changes, that might make you pretty susceptible, and youd want to take all the necessary precautions.
Cooper-Knock pointed out that drugs that kickstart sluggish NK cells are already proposed to treat some types of cancer. The drugs bind to receptors on the NK cells and trigger them to have a more robust response, he explained, noting that trials of NK cell infusions for severe COVID-19 are underway.
In a recent study published in Vaccines, researchers assessed the efficiency of a hybrid vaccine against influenza and coronavirus disease 2019 (COVID-19) viruses.
People worldwide are exposed to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as well as the influenza virus. Therefore the development of a two-in-one vaccine that could elicit protection against both these infections is a subject of great interest.
In the present study, researchers developed a hybrid vaccine using influenza virus-like particle (VLP) vaccine incorporated with glycosylphosphatidylinositol (GPI)-anchored SARS-CoV-2 receptor-binding domain (RBD) fused to granulocyte-macrophage colony-stimulating factor (GM-CSF) fusion protein.
The team developed a fusion protein gene by fusing deoxyribonucleic acid (DNA) sequences that are specific to the SARS-CoV-2 spike (S) protein RBD domain, GPI-anchor signal derived from human CD59, and mouse GM-CSF. Flow cytometry was subsequently performed to demonstrate the expression of the fusion protein on the transfected CHO-S cells. The team also assessed whether the anti-RBD antibodies present in the convalescent sera collected from SARS-CoV-2-infected patients identified the RBD of the fusion protein by performing an enzyme-linked immunosorbent assay (ELISA).
The team subsequently evaluated whether the fusion protein had two functions as GM-CSF and while also binding to human ACE2. Furthermore, the researchers developed the VLP hybrid vaccine by incorporating the influenza VLP with GPI-RBD-GM-CSF and GPI-interleukin (IL)-12 via protein transfer. Flow cytometry was also conducted using anti-GM-CSF antibodies and fluorochrome-conjugated anti-IL-12 to verify the dual incorporation of the GPI-RBD-GM-CSF and GPI-IL-12 onto VLPs. The retention of function by VLP-incorporated GM-CSF was verified by culturing mouse bone marrow-derived dendritic cells (BDMC), followed by the measurement of BMDC proliferation using XTT assay.
The team tested the induction of antibody response by the GPI-RBD-GM-CSF fusion protein by immunizing BALB/c mice with either the fusion protein or VLPs incorporated into the fusion protein along with GPI-IL-12. VLP without cytokines or commercially available RBD was used as control. The team administered a booster dose to the mice population two to four weeks after the first dose. Blood samples were obtained from the mice every two to four weeks in order to estimate antibody titer, virus neutralization assays, and ACE2 binding inhibition.
The study results showed that almost 76% of the fusion protein was secreted from the cell surface of the RBD-GM-CSF fusion protein, which suggested that the fusion protein was anchored into the cell membrane through a GPI tail. The RBD in the fusion protein exhibited ACE2 binding activity while RBD-specific neutralizing antibodies could bind to GPI-RBD-GM-CSF present on the CHO-S cell transfectants.
Antibodies found in the sera of COVID-19 patients could efficiently bind to the GPI-RBD-GM-CSF. Moreover, ELISA confirmed that RBD from the purified fusion protein retained its receptor binding activity. Additionally, the XTT assay showed that GPI-RBD-GM-CSF that was incorporated in the VLP vaccine could effectively stimulate BMDC proliferation.
The team observed that the VLP hybrid vaccine elicited a significant antibody response after the administration of the GPI-RBD-GM-CSF booster dose. The antibody response elicited by the fusion protein was similar in both the intramuscular and subcutaneous routes of vaccine administration. The antibodies selectively bound to the CHO-S cells which expressed the fusion protein but not to the untransfected CHO-S cells. This indicated the high specificity of the antibody response to the fusion protein.
The team also noted that the purified GPI-RBD-GM-CSF fusion protein-induced antibody levels that were comparable to those elicited by the VLP hybrid vaccine. However, the neutralizing antibody titers were considerably low in the mice that were immunized by only the GPI-RBD-GM-CSF protein without any VLP. This suggested that fusion protein that was incorporated with VLP elicited a more robust neutralizing antibody response as compared to that of the soluble fusion protein.
Furthermore, the purified GPI-RBD-GM-CSF fusion protein alone or when incorporated with VLPs induced a substantial antibody response. On its own, the fusion protein induced a primarily Th2 type immunoglobulin 1 (IgG1) response while the hybrid VLP vaccine elicited both IgG1 and IgG2a responses. Notably, the incorporation of GPI-IL-12 into the hybrid VLP vaccine did not affect the IgG2a response.
The team also observed that the hybrid vaccine by itself and the hybrid vaccine without IL-12 elicited robust antibody responses against the RBD as well as the influenza VLP antigens. These antibodies could sufficiently neutralize live virus infection when assessed via a plaque reduction neutralization titer (PRNT) assay. Moreover, substantially reduced viral replication was observed in the hybrid vaccine-treated mice as compared to the VLP-treated ones.
Overall, the study findings showed that the delivery of SARS-CoV-2 RBD protein via influenza VLPs along with cytokine adjuvants served as an effective platform for the development of multivalent vaccines. The researchers believe that the usage of immobilized cytokines as an adjuvant will help elicit anti-viral immunity with minimal adverse effects.
Journal reference:
COLUMBUS, Ohio The Ohio Department of Health (ODH) will host a briefing to update Ohioans on the status of COVID-19 in the state, the department announced in a news release.
The briefing is scheduled to begin at 11 a.m. Watch it live in the media player below:
News 5 livestream event
ODH Medical Director Dr. Bruce Vanderhoff will be joined by Dr. Michael Forbes of Akron Childrens Hospital and Dr. Grant Paulsen of Cincinnati Childrens Hospital.
This briefing comes after a government advisory panel has endorsed a second brand of COVID-19 vaccine for school-age children and teens.
The expert panel agreed Tuesday that the vaccine made by Moderna is safe and effective enough to give to U.S. kids ages 6 to 17.
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JAMM AQUINO / JAN. 20
Angelica Bagaoisan, medical assistant with Project Vision Hawaii, secures a COVID-19 antigen test sample during a vaccination and testing clinic put on by Honolulu Community Action Program, Project Vision Hawaii, and Kaiser Permanente at Palama Settlement.
The Hawaii Department of Health today reported 7,199 new COVID-19 infections over the past week, bringing the total since the start of the pandemic to 297,851 cases.
State health officials also reported nine coronavirus-related deaths, bringing the states coronavirus-related death toll to 1,474.
The states seven-day average of new cases today was reported at 976 compared to 1,085 on June 8, representing a decrease for the second week in a row after more than two months of increases. The seven-day average reflects new cases per day from June 4 to 10.
The states average positivity rate, meanwhile, decreased to 18.9% from 19.2% reported last week. It is the first decrease in the positivity rate reported after two-and-a-half months of consecutive increases.
The average positivity rate reflects a different set of seven days tests performed between June 7 and 13.
By island, there were 5,276 new infections reported on Oahu, 803 on Hawaii island, 602 on Maui, 377 on Kauai, 10 on Molokai and 10 on Lanai. Another 121 infections were reported out of state.
The Hawaii Emergency Management Agencys dashboard reported 218 patients with COVID-19 in hospitals today, up from 190 reported on June 8. Of the 218, 10 are in the intensive care unit and five are on ventilators.
Patient deaths: 1,011,925
Total vaccine doses distributed: 756,780,755
Patients whove received the first dose: 259,048,060
Patients whove received the second dose: 221,768,203
% of population fully vaccinated (both doses, not including boosters): 66.8%
% tied to Omicron variant: 100%
% tied to Other: 0%
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On 10 June 2022, the World Health Organization (WHO) in Zambia with the kind support of the Gavi Alliance donated 700 data collection electronic devices and related accessories worth One Hundred and Twenty Two Thousand, Two Hundred and Ninety US Dollars (US$122,290) to the Monitoring and Evaluation (M&E) Department of the Ministry of Health (MoH) to support the efficient and effective real-time data collection, monitoring and evaluation of the COVID-19 vaccination process and related information.
Dr Nathan Bakyaita, WHO Country Representative, said, We acknowledge the many challenges that the Ministry is facing, especially in the real-time data collection and tracking of COVID-19 related information, and specifically during the COVID-19 vaccination exercise. Our appreciation also goes to Gavi who has been a valuable partner to WHO and the Government of Zambia supporting the National Immunisation program and keeping Zambians safe from vaccine preventable diseases such as diarrhoea, measles, polio, cholera, and COVID-19. WHO in Zambia will continue to work with partners, like the Gavi Alliance to bridge gaps and provide better interventions, including the provision of necessary tools, so that all critical information is captured for a continued better response and management of the COVID-19 pandemic.
Hon Sylvia Masebo, Minister of Health, said, The donation is timely and will used for the intended purpose. We are grateful to the WHO Zambia, as through your office, we continue to get support for various interventions. As a ministry we know that the figures we report are not complete due to the many challenges that our workers face in data collection. These tablets will help us manage the COVID-19 data, bridge the gap in data backlog and allow for our foot soldiers to efficiently enter and manage COVID-19 and related information.For Zambia to attain the target of 70 percent of the population fully vaccinated against COVID-19, there is need for accurate and up-to-date data collection, capture and management.
Zambia now stands at over three million persons fully vaccinated giving an average of about 37 per cent of the population fully vaccinated against COVID-19. The tablets will make it easier for health personnel to capture and share data related to COVID-19 vaccination in Zambia.
The Gavi Alliance has been WHOs number six top contributor globally with a contribution of more than USD 432m in 2020/21 and is moreover, along with Germany the number one top contributor to WHO Zambia. Gavi is also one of the co-leads of COVAX, an alliance that aims to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.
NEW YORK and MAINZ, GERMANY, APRIL 26, 2022 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-g booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12).
The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-g two-dose primary series, which was authorized under EUA for this age group in October 2021. Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals.
The companies also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world for authorization in the coming weeks.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTechs proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
About the Phase 1/2/3 Trial in ChildrenThe Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. The trial was originally designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10-g each while children under age 5 received a lower 3-g dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. In December 2021, Pfizer and BioNTech announced the companies would test a third 3-g dose given at least two months after the second dose in children under age 5 and a third dose of the 10-g formulation in children 5 to under 12 years of age. The companies expect to share data from the ongoing study in children 6 months to under 5 years of age later this quarter.
U.S. Indication & Authorized Use
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:
Primary Series
Booster Series
COMIRNATY INDICATIONCOMIRNATY (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
COMIRNATY AUTHORIZED USESCOMIRNATY (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:
Primary Series
Booster Dose
Emergency Use AuthorizationEmergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in either individuals 12 years of age and older, or in individuals 5 through 11 years of age, as appropriate. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
INTERCHANGEABILITYFDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA-authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.
The formulation of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age differs from the formulations authorized for individuals 12 years of age and older and should therefore not be used interchangeably. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age should not be used interchangeably with COMIRNATY (COVID-19 Vaccine, mRNA).
IMPORTANT SAFETY INFORMATION
Tell your vaccination provider about all of your medical conditions, including if you:
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients
You should not receive Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) if you have had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY
There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital
Seek medical attention right away if you have any of the following symptoms:
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low
Seek medical attention right away if you have any of the following symptoms after receiving the vaccine:
Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask you to sit or lie down for 15 minutes after receiving the vaccine
Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA)
Additional side effects include injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; and fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.
Click for Fact Sheets and Prescribing Information for individuals 5 years of age and older:
Recipients and Caregivers Fact Sheet (5 through 11 years of age)Recipients and Caregivers Fact Sheet (12 years of age and older)COMIRNATY Full Prescribing Information (16 years of age and older), DILUTE BEFORE USE, Purple CapCOMIRNATY Full Prescribing Information (16 years of age and older), DO NOT DILUTE, Gray CapEUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange CapEUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple CapEUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap
About Pfizer: Breakthroughs That Change Patients LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the worlds premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure NoticeThe information contained in this release is as of April 26, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizers efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including an application submission to the FDA for EUA of a potential booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age and planned submissions to other regulatory agencies, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data) for BNT162b2 or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2 or any potential future vaccines (including potential submissions for a potential booster dose for children 5 through 11 years of age and potential future annual boosters or re-vaccinations) and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, including a potential variant based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including the application submission to the FDA for EUA of a potential booster dose for children 5 through 11 years of age or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant based vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking StatementsThis press release contains forward-looking statements of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including an application submission to the FDA for EUA of a potential booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age, who have previously received a two-dose primary series of the Pfizer-BioNTech COVID-19 vaccine, and planned submissions to other regulatory agencies, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials, real world data studies, and/or in commercial use based on data observations to date; the ability of BNT162b2 or a future vaccine to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for BNT162, or any future vaccine, in additional populations, or receipt of, any marketing approval or emergency use authorization or equivalent, including or amendments or variations to such authorizations; the development of other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant based vaccines; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2022; challenges related to public vaccine confidence or awareness; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; the availability of raw material to manufacture BNT162 or other vaccine formulation; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; and uncertainties regarding the impact of COVID-19 on BioNTechs trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.
For a discussion of these and other risks and uncertainties, see BioNTechs Annual Report as Form 20-F for the Year Ended December 31, 2021, filed with the SEC on March 30, 2022, which is available on the SECs website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
June 13, 2022
OSWEGO COUNTY Oswego County continues to see a decrease in the number of COVID-19 positive cases and hospitalizations. Still, residents are reminded to stay vigilant and practice known strategies that work to reduce the spread of the virus. These include staying home when sick, testing when symptomatic, getting vaccinated and boosted when eligible, and choosing to wear a mask as an additional protection measure.
While no vaccine provides 100% immunity, the COVID-19 vaccines are highly effective in protecting you from becoming severely ill, ending up in the hospital, or dying from COVID-19 and getting a booster strengthens that protection even further,said Jodi Martin, director of preventive services for the Oswego County Health Department. Everyone eligible should get vaccinated and boosted as a way to protect the health of all in our community.
Oswego County Associate Public Health Educator Diane Oldenburg added, Getting eligible children and teens vaccinated against COVID-19 can help keep them from getting really sick if they do get the virus. Vaccinations can also keep them in school, summer campsor daycare and safelyparticipating in sports, playdates, and other group activities. Talk with your healthcare provider about getting your children vaccinated and boosted.
The Oswego County Health Department reported an additional 141 residents tested positive for the virus from Monday, June 6 through Sunday, June 12. This includes both lab-confirmed and at-home tests. In addition, three residents were hospitalized due to COVID-19 between Sunday, June 5 and Saturday, June 11.
The following report reflects data collected from Monday, June 6 through Sunday, June 12:
The Oswego County Health Department receives weekly accounts of new hospitalizations due to COVID-19 from local reporting hospitals including Oswego, Crouse, St. Josephs Health and Upstate University. These accounts are not part of a running total of hospitalizations. For details, go to the Oswego County COVID-19 Dashboard at https://oswegogis.maps.arcgis.com/apps/dashboards/3fd162cd12264b418dc03bdebd7f5300.
The Oswego County Health Department holds vaccination clinics every Tuesday afternoon from 12:30 to 3:30 p.m. by appointment only. Clinics are also held the second Wednesday of each month, from 9 to 11 a.m. and 1 to 3 p.m. Walk-ins are accepted on Wednesdays, but residents are strongly encouraged to go to health.oswegocounty.com/vaccines to make an appointment to avoid wait times.
The Oswego County Office for the Aging can help people aged 60 and older who need help navigating the internet to make appointments. Call 315-349-3484.
Vaccines are also available at local pharmacies and health care provider offices. Face masks are required at all clinics and at-home COVID-19 test kits will be distributed to those getting vaccinated at a county clinic while supplies last.
Free transportation is provided to residents to go to COVID-19 testing and vaccination sites through a partnership between Oswego County and Oswego County Opportunities, Inc. Rides are available between 6 a.m. and 7 p.m. Monday through Friday. Call 315-598-1514 to schedule a ride in advance.
Oswego County developed a portal for residents to report positive at-home COVID-19 test results, exposure to the virus and get the necessary isolation/quarantine paperwork for schools and employers. Go to https://health.oswegocounty.com/COVID-19 and click on the appropriate link.
Test results received from doctors offices, pharmacies and other testing sites DO NOT need to be self-reported. However, if isolation orders are needed for school, employers or other reasons, people can request these documents using the portals Report a Positive (Laboratory) Test option.
The health department encourages residents who test positive to immediately notify any close contacts. The close contact should then go to the States website at https://coronavirus.health.ny.gov/new-york-state-contact-tracing to find out if they meet the criteria for quarantine. If they do, they should report the exposure on the County Health Departments online portal.
Residents are urged to continue taking precautions to prevent the spread of COVID-19 including:
For more information, go to the Oswego County Health Departments COVID-19 page at https://health.oswegocounty.com/COVID-19 or call its COVID-19 Hotline at 315-349-3330. Callers may need to leave a message and a staff member will return the call.
Residents should contact their medical providers directly for personal medical advice about COVID-19 and vaccinations or booster shots.
For information about emotional supports, visit the Oswego County Department of Social Services Division of Mental Hygiene at www.oswegocounty.com/mentalhygiene.
Under New York State Public Health Law, the Oswego County Health Department is the local public health authority regarding the COVID-19 pandemic response within the County of Oswego. The Oswego County Health Department works closely with New York State Department of Health regarding COVID-19 monitoring, response, and reporting.
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