On May 16, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a clinical trial collaboration and supply agreement with Merck (known as MSD outside the US and Canada) (Press release, Athenex, MAY 16, 2022, View Source [SID1234614661]). The agreement applies to the expansion phase of the Phase 1 clinical trial evaluating Athenex’s oral paclitaxel in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for certain NSCLC patients.

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The agreement will support the expansion phase of the trial to further investigate the preliminary encouraging results of the KX-ORAX-011 Phase 1 clinical trial evaluating Oraxol (encequidar plus oral paclitaxel) in combination with pembrolizumab for certain NSCLC patients. The two companies will form a Joint Development Committee to review the clinical trial results.

"We are keen to collaborate with Merck to further investigate the therapeutic potential of Oraxol plus KEYTRUDA in patients with NSCLC patients who progressed on previous anti-PD1/ anti-PD-L1 therapy or in combination with chemotherapy," said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. "If the preliminary efficacy and safety data can be confirmed, it may lead to a new paradigm in the treatment of certain NSCLC patients."

KX-ORAX-011 is an ongoing Phase 1 trial evaluating Oraxol in combination with pembrolizumab in patients with advanced solid tumors. Following completion of the dose escalation phase, the expansion phase is currently evaluating the combination therapy in patients with NSCLC who progressed on previous anti-PD1/ anti-PD-L1 therapy or in combination with chemotherapy. The NSCLC expansion cohort is actively recruiting and aims to enroll approximately 50 patients.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Oral Paclitaxel
Athenex’s oral paclitaxel and encequidar ("oral paclitaxel") is in the earlier stages of development for solid malignancies. Encequidar, the cornerstone of Athenex’s Orascovery technology platform, is a highly specific and potent inhibitor of the transport protein called P-glycoprotein (P-gp) in the gastrointestinal (GI) tract. By localizing P-gp inhibitory activity in the GI tract, encequidar improves the absorption of chemotherapeutic agents while limiting the potential for unnecessary P-gp inhibition at other sites in the body. The potency, selectivity, and low absorption of encequidar enables the oral administration of IV chemotherapies.

On May 16, 2022 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines designed to bring the curative power of stem cell transplant to more patients, reported financial results for the first quarter ending March 31, 2022, early clinical observations from its MGTA-117 clinical trial and other recent program highlights (Press release, Magenta Therapeutics, MAY 16, 2022, View Source [SID1234614660]).

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"We are pleased with the progress of our MGTA-117 Phase 1/2 clinical trial. Our clinical observations from preliminary data indicate that MGTA-117 is functioning as designed by binding to the intended cells with a post-dose reduction of target cells in the bone marrow, clearing the body rapidly and doing so with a favorable tolerability profile. With this level of measurable activity at our lowest dose, we believe we will collect enough information in 2022 from the next 1-2 cohorts to build a data set for communications with regulators for our planned transition to the transplant-eligible AML patient population. In light of the turbulence in the capital markets, we are also pleased to have a strong cash position and a projected lower quarterly spending rate which we believe will allow us to reach our critical value inflection points, including possible proof-of-concept of MGTA-117 in transplant-eligible AML patients and genetic diseases with gene therapy," said Jason Gardner, President and Chief Executive Officer of Magenta Therapeutics.

Program Highlights:

MGTA-117 Phase 1/2 Clinical Trial Ongoing

Clinical Trial Design and Objectives. Magenta is conducting a Phase 1/2 dose-escalation clinical trial of MGTA-117 in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome with excess blasts (MDS-EB).

Clinical Trial Status and Scope of Early Clinical Observations. The clinical trial has progressed from Cohort 1 to Cohort 2 after meeting all protocol requirements for dose escalation. Patients in Cohort 1, as expected, had varying degrees of disease burden as measured in part by the percentage of leukemic cells in the bone marrow and the bloodstream. Clinical observations were made from a preliminary data set from Cohort 1 which utilizes the trial’s lowest dose of MGTA-117 (0.02 mg/kg). Three patients with relapsed/refractory AML completed the safety evaluation period. A fourth patient with high disease burden did not complete the evaluation period due to disease progression with no drug-related adverse events. Cohort 2 is now open and enrolling and MGTA-117 will be evaluated as a single dose of 0.04 mg/kg.
Early Clinical Observations from Cohort 1.
Target Engagement/Binding: Preliminary data from four patients were available for measuring target engagement. In all patients, MGTA-117 was shown to bind CD117+ cells in the blood as measured by a receptor occupancy assay.
Cell Depletion: Bone marrow aspirates were obtained for three patients at baseline and post-dosing and provided evidence supportive of biologic activity.
Reductions of Erythroid Progenitor Cells in the Bone Marrow: One patient had measurable reductions of CD117+ erythroid progenitor cells in the bone marrow following MGTA-117 administration.
Reductions of Blasts in the Bone Marrow: An additional patient had an approximate 83% reduction of blasts in the bone marrow at day 14 post-dosing (from 6% to 1%). The patient proceeded to a conditioning regimen followed by stem cell transplant. The patient’s baseline profile closely resembled that of transplant-eligible AML patients due to relatively low percentages of blasts in the bone marrow and bloodstream. Magenta believes that this outcome provides an encouraging early signal in support of MGTA-117’s planned transition to the transplant-eligible AML patient population.
Rapid Drug Clearance: Preliminary data from four patients were available for measuring drug clearance. In all patients, MGTA-117 was deemed to be cleared 48 hours after dosing. Rapid and sufficient clearance of conditioning agents from circulation is a necessary step before stem cell infusion.
Favorable Tolerability Profile: For all four patients, no unexpected or serious drug-related adverse events were reported, no dose-limiting toxicities were observed and no drug-related adverse events higher than Grade 1 were reported.
"We are encouraged by these preliminary data. Post-dose reduction of progenitor and tumor blast cell populations in bone marrow suggests biologic activity. We anticipate that dose escalation will lead to further drug activity and enable identification of an appropriate dose for development in patients eligible for transplant," said Dr. Jeff Humphrey, Chief Medical Officer of Magenta Therapeutics.

MGTA-117 Clinical Data Disclosure Expectations in 2022. Magenta expects to report additional progress updates and clinical observations from multiple dose-escalation cohorts in 2022, including providing patient-level data from this clinical trial at a scientific congress later this year.
Plans to Transition to Transplant-Eligible Patients. The company anticipates that further data from the current clinical trial showing MGTA-117 at high receptor occupancy levels with well-tolerated cell depletion in the blood and/or bone marrow will be supportive of the planned transition to transplant-eligible patients. Magenta is planning to engage with regulatory authorities prior to amending the clinical trial protocol to evaluate MGTA-117 as a targeted conditioning agent in combination with reduced intensity chemotherapy prior to a stem cell transplant. Simultaneously with the planned clinical trial transition, Magenta expects to initiate clinical collaboration planning with existing and potential gene therapy partners to explore MGTA-117 as a single agent conditioning regimen prior to autologous stem cell gene therapy.
CD45-Antibody Drug Conjugate (ADC): Second Targeted Conditioning Program

CD45 is broadly expressed on hematopoietic cells and Magenta’s CD45-ADC is designed to selectively target and deplete both stem cells and lymphocytes, which would enable patients with blood cancers and autoimmune diseases to avoid the use of chemotherapy prior to stem cell transplant.

Magenta has initiated IND-enabling studies with data from a key dose-ranging toxicology study expected in the second half of 2022.
MGTA-145 Stem Cell Mobilization and Collection

Magenta is developing MGTA-145, in combination with plerixafor, to improve stem cell mobilization from bone marrow into the bloodstream. Collection of peripheral blood stem cells, known as stem cell mobilization, is a common source of stem cells for hematopoietic stem cell transplants and gene therapy applications.

Magenta is preparing for the initiation of a Phase 2 clinical trial in sickle cell disease (SCD) in collaboration with bluebird bio to evaluate MGTA-145, in combination with plerixafor, for mobilization and collection of stem cells in patients with sickle cell disease. Mobilization and collection are difficult in sickle cell disease, and there is a clear unmet medical need. Initial data from this trial are expected in the second half of 2022.
Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2022, were $156.6 million, compared to $176.9 million as of December 31, 2021. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund its current operational plan into the second quarter of 2024.

Research and Development Expenses: Research and development expenses were $16.5 million in the first quarter of 2022, compared to $11.7 million in the first quarter of 2021. The increase was driven primarily by the achievement of a development milestone under Magenta’s license agreement related to MGTA-117, an increase in preclinical and manufacturing costs to support our CD45-ADC IND enabling studies, offset by a decrease in costs related to MGTA-456 which was discontinued. The increase was also due to an increase in research and development headcount.

General and Administrative Expenses: General and administrative expenses were $7.3 million for the first quarter of 2022, compared to $7.0 million for the first quarter of 2021.

Net Loss: Net loss was $23.0 million for the first quarter of 2022, compared to net loss of $17.5 million for the first quarter of 2021.

On May 16, 2022 Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended March 31, 2022 (Press release, Galectin Therapeutics, MAY 16, 2022, View Source [SID1234614659]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Dr. Pol Boudes, Chief Medical Officer, stated: "As we hear more about difficulties of reading and interpreting liver biopsies in pre-cirrhotic NASH, the feedback we get from our investigators reinforces our belief that using the prevention of esophageal varices as our primary outcome of efficacy in NAVIGATE is the appropriate efficacy outcome. Patients that are enrolled in our program have advanced to the cirrhotic stage of NASH and have developed portal hypertension, a severe complication of cirrhosis that impacts their prognosis. This also means that many of our patients have low platelet counts, and because this increases the risk of bleeding, it makes a liver biopsy far too dangerous. These are some of the reasons why we do not believe that biopsies are appropriate for patient selection or endpoints in our target population and is also why we even removed the requirement for baseline biopsies in our NAVIGATE trial. Preventing the development of an esophageal varix, on the other hand, is a very relevant and pragmatic clinical outcome. Unfortunately, too many cirrhotic patients bleed from these varices, and this can be a life-threatening event. Preventing the development of varices eliminates this potentially significant adverse outcome related to cirrhosis. We believe the design of the NAVIGATE study is truly innovative and allows us to move clinical research for liver cirrhosis forward."

Joel Lewis, Chief Executive Officer and President, said: "I am proud of our team and their accomplishments this quarter. Most importantly, as a Company, we achieved an extremely significant milestone. Our previous phase 2 trial, NASH-RX, indicated a favorable safety profile for belapectin over one year of treatment. As of today, due to the length of our adaptively designed phase 2b/3 NAVIGATE trial, our safety profile has been further evaluated by an independent data safety monitoring board who recommended the trial continue as designed. Additionally, our innovative trial design allows trial participants to move directly into the phase 3 treatment course for an additional 18 months. As these and additional patients continue receiving treatment, we continue to expand our data on the safety profile of belapectin. The significance of this safety profile in a severely compromised patient population cannot be overstated.

"We continued to make progress towards our primary goal of completing enrollment in our adaptively designed Phase 2b/3 NAVIGATE trial for the prevention of esophageal varices in patients with NASH cirrhosis. Our strategy to further expand our trial sites in Mexico and Latin America is well underway. We recently conducted a very productive in-person investigator meeting in Mexico where we have added more than 10 new sites. I attended the meeting with my clinical operations staff, and we are extremely enthusiastic about the ability of these sites to quickly enroll patients. I am grateful to all of our investigators and their teams, as well as our consultants in Mexico, for their time and dedication to our trial. Enrollment in the United States continued steadily; however, enrollment in Europe still lags far behind our expectations. We currently expect enrollment to conclude for the Phase 2b portion around the end of the third quarter of this year."

Mr. Lewis continued: "Additionally, we are making progress and are working to compile an Investigational New Drug (IND) package, including the development of a phase 2 trial protocol, with the objective for the Company to file an IND with the FDA oncology division for the treatment of recurrent or metastatic head and neck cancer for belapectin in combination with Keytruda, an immune checkpoint inhibitor. The lack of current treatments for these patients, the low response rates of monotherapy with check-point inhibitors, the limited number of therapies in development, and the resulting very high medical need make this an important area for new combination therapies."

Financial Results

For the three months ended March 31, 2022, the Company reported a net loss applicable to common stockholders of $9.9 million, or ($0.17) per share, compared to a net loss applicable to common stockholders of $6.3 million, or ($0.11) per share for the three months ended March 31, 2021. The increase is largely due to an increase in 2022 research and development expenses related to the Company’s NAVIGATE trial.

Research and development expenses for the three months ended March 31, 2022, was $8.1 million compared with $4.9 million for the three months ended March 31, 2021. The increase was primarily due to costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended March 31, 2022, were $1.9 million, compared to $1.4 million for the three months ended March 31, 2021. The increase was primarily due to non-cash stock-based compensation expense.

As of March 31, 2022, the Company had $31.6 million of cash and cash equivalents. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through at least May 16, 2023.

The Company expects that it will require more cash to fund operations after May 16, 2023, and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $40-$45 million to cover costs of the NAVIGATE trial to reach the planned interim analysis estimated to occur in mid-2024, along with drug manufacturing and other research and development activities and general and administrative costs. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

About Belapectin

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis," began enrolling patients in June 2020, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.

On May 16, 2022 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported its financial results for the quarter ended March 31, 2022 (Press release, Renovorx, MAY 16, 2022, View Source [SID1234614658]).

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"As we report our Q1 2022 results, we acknowledge that May is Cancer Research Month. RenovoRx is fighting cancer through our innovative localized treatment of difficult-to-treat tumors via our proprietary RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) therapy platform," said Shaun Bagai, CEO of RenovoRx. "Today, we are midway through a Phase 3 pancreatic cancer clinical trial, designed to provide an improved treatment option to the generally ineffective standard of care, systemic (intravenous) chemotherapy for patients. The study’s goal is to improve survival and quality of life for patients with a cancer that currently has a five-year survival rate of 11%."

Bagai added, "RenovoRx is at the frontline of cancer research with our late-stage product candidate, RenovoGemTM. Later this year, we plan on extending its utility to extrahepatic cholangiocarcinoma (eCCA), a rare and aggressive cancer that forms in bile ducts that lead out of the liver and join with the gallbladder. The FDA granted RenovoRx Orphan Drug Designation for this indication in April 2021, and for pancreatic cancer in 2018."

Financial Highlights for the Quarter Ended March 31, 2022

●Cash and cash equivalents as of March 31, 2022, were $13.1 million.
●Research and development expenses were $1.3 million for the quarter ended March 31, 2022, compared to $0.6 million for the quarter ended March 31, 2021. The increase was due to higher costs incurred on our Phase 3 trial, including consulting, employee and related benefit costs, and an increase in costs for a secondary manufacturer of our RenovoCath delivery systems.
●General and administrative expenses were $1.7 million for the quarter ended March 31, 2022, compared to $0.4 million for the quarter ended March 31, 2021. This increase was due to higher employee and related benefits costs, an increase in legal fees reflecting the costs of public company compliance requirements, an increase in professional and consulting services relating to post-IPO support, and Directors and Officers Liability Insurance.
●Net loss was $3.0 million for the quarter ended March 31, 2022, compared to net loss of $1.1 million for quarter ended March 31, 2021.
●As of March 31, 2022, the Company had 9,029,305 common shares outstanding.

About the Phase 3 TIGeR-PaC Clinical Trial

TIGeR-PaC is a randomized multi-center Phase 3 study using RenovoRx’s innovative therapy platform, RenovoTAMPTM (RenovoRx Trans-Arterial Micro-Perfusion). The study is evaluating the Company’s first product candidate, RenovoGemTM, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source

On May 16, 2022 Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") reported they have reached an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Pfizer-BioNTech COVID-19 Vaccine (Press release, BioNTech, MAY 16, 2022, View Source [SID1234614657]). This amendment rephases planned deliveries to help support the European Commission and Member States’ ongoing immunization programs, and is aligned to the companies’ commitment to working collaboratively to identify pragmatic solutions to address the evolving pandemic needs. Doses scheduled for delivery in June through August 2022 will now be delivered in September through fourth quarter 2022. The companies’ full-year 2022 revenue guidance and the full-year commitment of doses to be delivered to EC Member States in 2022 remain unchanged.

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Pfizer and BioNTech continue to evaluate potential adapted vaccines, including variant-based vaccines.

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

a 2-dose primary series to individuals 5 years of age and older
a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise
Booster Series

a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA)
a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine
COMIRNATYINDICATION

COMIRNATY (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 is administered as a 2-dose primary series
COMIRNATY AUTHORIZED USES

COMIRNATY (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:

Primary Series

a 2-dose primary series to individuals 12 through 15 years of age
a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
Booster Dose

a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY
a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

Emergency Use Authorization

Emergency 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.

INTERCHANGEABILITY

FDA-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:

have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
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 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:

difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
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:

chest pain
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
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.

You should always ask your healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985