Spotlight

For certain product types, there is a requirement for testing to determine the absence of certain microorganisms. These specified microorganisms include pathogens and are known as indicator microorganisms. This is due to the fact that they may indicate the presence of other microorganisms from similar sources that are known to be hazardous for immunocompromised and other high-risk patients.

Related News

RESEARCH

Pfizer/Biontech Weren't Alone: Moderna Covid-19 Vaccine Data Aimed in Ema Cyberattack

Moderna | December 16, 2020

It would appear that Pfizer and BioNTech's COVID-19 immunization was not the sole objective of a new cyberattack at the European Medicines Agency. Moderna said Monday that reports from its pre-accommodation conversations with EMA about its shot, mRNA-1273, were "unlawfully gotten to" by programmers, refering to a warning from the organization. The assailants didn't get individual data about preliminary members, Moderna said. The organization's EMA accommodation did exclude any information recognizing people in the examination. Now, no extra insights concerning the cyberattack, for example, the size of the penetrate or the character of any suspects—are accessible, and Moderna said it anticipates results from EMA's progressing examination. The disclosure came days after the EMA initially uncovered the cyberattack, and Pfizer and BioNTech's COVID-19 immunization applicant, BNT162b2, was the principal distinguished as an objective. EMA choices on the two immunizations are moving close. Medication commentators at the EMA's Committee for Medicinal Products for Human Use are booked to evaluate BNT162b2 on Dec. 29 and mRNA-1273 on Jan. 12. Moderna was recently focused by programmers looking for its COVID-19 examination, in a cyberattack supposedly upheld by the Chinese government. The U.S. Branch of Justice in July arraigned two Chinese nationals for running a 10-year hacking effort that most as of late rotated to focusing on organizations doing COVID research. Reuters later affirmed Moderna as the antibody producer referenced in the arraignment. China has denied any function in such practices. Other than Moderna and Pfizer/BioNTech, rival COVID immunization designers AstraZeneca, Johnson and Johnson and Novavax apparently have arrived in the line of sight of North Korean programmers. In those hacking endeavors, the assailants regularly conveyed noxious reports or connections by means of email under the appearance of occupation enrollment specialists, partners or different associates of the person in question, as indicated by individuals acquainted with the issue refered to by The Wall Street Journal. Country state programmers from Iran and Russia have likewise been blamed for attempting to take COVID-related data.

Read More

PHARMACY MARKET

Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine

Pfizer | August 17, 2021

Pfizer Inc. and BioNTech SE today announced that they have submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.” “Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.” “We continuously strive to stay at least one step ahead of the virus. This is why we aim to expand access to our vaccine for people around the world and are working on various approaches as part of our comprehensive strategy to address the virus and its variants today as well as in the future,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine. A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season.” Pfizer and BioNTech have submitted Phase 1 data – part of their Phase 1/2/3 clinical trial program – evaluating the safety, tolerability, and immunogenicity of a third dose of the COVID-19 vaccine in U.S. adult participants from the Phase 1 trial of the two-dose series. Participants received a 30-µg booster dose of BNT162b2 8 to 9 months after receiving the second dose. Results from this participant group show that the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus (wild type) compared to the levels observed after the two-dose primary series, as well as against the Beta variant and the highly infectious Delta variant. Phase 3 results evaluating the third dose are expected shortly and will be submitted to the FDA, the EMA and other regulatory authorities worldwide. In the U.S., Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application (BLA) in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in May 2021. A third dose of the Pfizer-BioNTech vaccine is not currently authorized for broad use in the U.S. However, under the current amended Emergency Use Authorization, a third dose was authorized on August 12 for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. This authorization is based on information from an independent report evaluating safety and effectiveness of a third dose in people who received solid organ transplants. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing or planned. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. The emergency use of this product is 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. AUTHORIZED USE IN THE U.S.: The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an 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 12 years of age and older. IMPORTANT SAFETY INFORMATION Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%) In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%) Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm). myocarditis and pericarditis Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization. About Pfizer: At 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 world's 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.

Read More

Pfizer continues recalls of menopause drug Duavee on faulty packaging concerns

Fiercepharma | June 09, 2020

Consumers are on edge as the COVID-19 pandemic casts doubts on the quality of drugs reaching shelves around the world. On U.S. shores, experts say those issues are warranted—and a wave of Pfizer recalls for menopause drug Duavee won't help build confidence. Pfizer voluntarily recalled two batches of Duavee––marketed as Duavive abroad––from U.K. shelves after identifying faulty packaging that may have reduced the drug's efficacy, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) said Monday. Pfizer launched the recall after manufacturers identified a flaw in the drug's foil laminate pouch that introduced oxygen and lowered the dissolution rate of active pharmaceutical ingredient bazedoxifene acetate, the MHRA said.

Read More

Spotlight

For certain product types, there is a requirement for testing to determine the absence of certain microorganisms. These specified microorganisms include pathogens and are known as indicator microorganisms. This is due to the fact that they may indicate the presence of other microorganisms from similar sources that are known to be hazardous for immunocompromised and other high-risk patients.