pharmaphorum

DECEMBER 4, 2020

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

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Vaccines Documentation 125

Express Pharma

JUNE 6, 2024

Stakeholders are invited to provide feedback on CDSCO draft guidance within 15 days from the notice’s issuance On May 29, 2024 a draft of the revised “Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines” was released for public consultation by Central Drug Standard Control Organisation (CDSCO).

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Vaccines Documentation 105

pharmaphorum

DECEMBER 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

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Vaccines Adverse Reactions Documentation Immunity 111

pharmaphorum

DECEMBER 10, 2020

The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed. Shortly after however BioNTech confirmed that documents submitted as part of its marketing application for coronavirus vaccine BNT-162b had been accessed by the hackers.

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Vaccines Documentation 111

pharmaphorum

DECEMBER 10, 2020

The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone to serious allergic reactions. Both recovered after appropriate treatment. Both are recovering well.”.

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Vaccines Documentation 103

The Pharmacist

DECEMBER 18, 2023

NHS England (NHSE) expects Covid-19 vaccines to become available for private purchase ‘in due course’, according to its newly published vaccine strategy. The document also revealed that the Department of Health and Social Care (DHSC) has ‘begun to facilitate conversations between manufacturers and providers to support this process’.

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Vaccines Documentation 91

pharmaphorum

MARCH 2, 2021

Zebra Technologies healthcare lead Chris Sullivan discusses the COVID-19 vaccine rollout and how technology can streamline the process to combat new variants. . While the rollout of the COVID-19 vaccine has signified the first signs of light at the end of the tunnel, the reality is that this public health crisis is still far from over.

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Vaccines Adverse Reactions Documentation Labelling 119

Express Pharma

AUGUST 23, 2023

The study was performed to understand whether the immunity gained after vaccination or a prior infection was less effective or “leaky” in situations where people are exposed to high levels of the virus.

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Vaccines Documentation Immunity Immunization 98

pharmaphorum

SEPTEMBER 17, 2020

US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. The post US experts stress over safety of AZ’s COVID-19 vaccine appeared first on.

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Vaccines Documentation Immunity Immunization 105

European Pharmaceutical Review

NOVEMBER 18, 2022

The World Health Organization (WHO)’s Global Vaccine Market Report 2022 , the first report to examine the impact of COVID-19 on the global vaccine market, shows that inequitable distribution is not unique to COVID-19 vaccines, with poorer countries consistently fighting to access vaccines in demand by wealthier countries.

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Vaccines Immunity Immunization Documentation 98

pharmaphorum

NOVEMBER 20, 2020

Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. On the efficacy side, the filing will highlight a vaccine efficacy rate of 95% in a phase 3 study testing patients with and without previous infection with SARS-CoV-2.

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Vaccines Documentation 96

pharmaphorum

JANUARY 13, 2021

Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update. The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records.

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Vaccines Documentation 82

Pharmaceutical Technology

SEPTEMBER 15, 2022

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.

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Vaccines Drug Pricing Documentation Biosimilars 108

Pharmacy Times

JUNE 10, 2025

Low uptake of vaccination to protect against invasive pneumococcal disease (IPD) was observed both before and after a pneumococcal-related hospitalization, with countless missed vaccination opportunities documented.

Hospitals 26

Hospitals Vaccines Documentation 26

Pharmafile

MAY 9, 2024

UK-based pharmaceutical company AstraZeneca has announced that is it voluntarily withdrawing its COVID-19 vaccine Vaxzevria due to a drop in global demand. The withdrawal also comes after AstraZeneca admitted in court documents that the vaccine can cause thrombosis with thrombocytopenia syndrome (TTS).

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Vaccines Documentation Pharmaceutical Companies Pharmaceutical Companies 59

Express Pharma

JUNE 20, 2023

The vaccine efforts of the COVID-19 pandemic highlighted our knowledge about gaps in the immune system. Institutional support, such as expert consultants, essential document templates, and protocols for regulatory submissions, is also vital. However, the spotlight has shifted to unravelling the complexities of the human immune system.

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Immunity Immunization Vaccines Hospitals 105

Eye on FDA

NOVEMBER 17, 2020

Coincident to COVID-19 case levels in Europe and the United States entering new and serious levels comes welcome news on the development of a vaccine. While vaccination may actually begin in December, the number of doses will be limited. In addition, the process of vaccination takes time.

Communication 81

Communication Vaccines HIPAA Documentation 81

European Pharmaceutical Review

JUNE 29, 2022

As the healthcare sector grows, there is a clear trend towards the expansion of biologic therapeutic drugs and vaccines like the one developed by Novavax. To summarise, bioproduction hurdles include the necessity to be fast, agile and, not to be understated, able to deliver safe and effective vaccines worldwide. _4W2cWlEb439CWlu?startTime=1632749714000

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Vaccines Documentation 98

pharmaphorum

JANUARY 28, 2022

The failure of the European Commission to locate text messages between its president Ursula von der Leyen and Pfizer chief executive Albert Bourla on procurement of COVID-19 vaccine has earned a rebuke from the EU Ombudsman. billion doses of Pfizer and BioNTech’s vaccine. billion doses of Pfizer and BioNTech’s vaccine.

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Vaccines Documentation 64

PharmaTech

OCTOBER 24, 2023

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

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Vaccines Documentation 52

pharmaphorum

FEBRUARY 24, 2021

AstraZeneca has said it will be able to meet a target to deliver 180 million COVID-19 vaccines to the EU in the second quarter, by topping up the supply from its global production network. However there is hope that vaccine production will be stepped up later on in the year, according to Reuters.

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Vaccines Documentation 64

pharmaphorum

JUNE 29, 2022

Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). They are however both based on the original BA.1 1 will be “already somewhat outdated.”

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Vaccines Immunity Immunization Documentation 52

Quality Matters

MAY 24, 2023

World Vaccine Congress 2023: Spotlight shines on mRNA and viral vectored technology platforms Interest in innovative vaccines that use messenger ribonucleic acid (mRNA) and viral vectored technologies was among the key draws at this year’s World Vaccine Congress (WVC) on April 3-6 in Washington, D.C.

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Vaccines Documentation Immunity Immunization 52

Pharmaceutical Technology

DECEMBER 13, 2022

To develop a vaccine and then get as many people vaccinated as quickly as possible. Advanced monitoring and analysis technology has enabled more than 13 billion COVID-19 vaccinations to be distributed worldwide to date. Before the COVID-19 pandemic, 25-50% of vaccines were wasted due to cold chain issues.

Vaccines 52

Vaccines Communication Documentation 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

The information contained within the download document is designed for pharmaceutical executives, developers, research scientists and associates, regulatory solutions consultants, and any other individual involved in API biologics production in the pharmaceutical industry.

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Vaccines Packaging Documentation Labelling 40

Putting Patients First Blog

APRIL 29, 2024

Recognizing both the potential benefits and challenges of the MPPP rollout, the NHC views the introduction of these documents as crucial for educating beneficiaries on their options, easing transitions, and possibly lessening the financial impact of prescription costs.

Documentation 40

Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

STAT

JULY 18, 2024

Europe’s second-highest court criticized the European Commission for a lack of transparency over Covid-19 vaccine contracts four years ago , Reuters writes. The EC says she did not keep the messages. Continue to STAT+ to read the full story…

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Documentation Vaccines 266

European Pharmaceutical Review

DECEMBER 19, 2023

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient.

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Vaccines Communication Immunity Immunization 111

Putting Patients First Blog

JUNE 16, 2025

Developers should be required to: Conduct inclusive usability testing with older adults, people with disabilities, caregivers, and individuals with limited English proficiency; Share documentation of feedback collection and integration; and Comply with Section 508 and WCAG 2.1 Incentivizing the use of HL7 FHIR, OAuth 2.0,

Documentation 52

Documentation Communication Immunization Immunity 52

pharmaphorum

JANUARY 29, 2021

The EMA has approved AstraZeneca’s COVID-19 vaccine for use in the EU in all adults aged over 18, despite assertions in Germany this week that it shouldn’t be used in elderly people. That’s in line with the conclusions of the MHRA, which approved the vaccine at the end of last year. Janssen shot 66% effective.

Vaccines 64

Vaccines Documentation 64

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world.

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Diabetes Documentation Biosimilars Compounding 242

Express Pharma

DECEMBER 31, 2024

India needs to focus on reducing dependency on single sources by qualifying other geographies Ashish Mohan, VP – Procurement and Supply Chain, Bharat Serums and Vaccines There are several challenges in the traceability of the pharma supply chain.

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Vaccines Documentation 105

STAT

JUNE 9, 2023

In documents released this week, FDA reviewers appeared receptive to granting full approval to Leqembi. Pfizer developed a vaccine that, if approved, will be given in pregnancy. Track the meeting here and here. The drug was developed by AstraZeneca, and will be marketed in the U.S. Continue to STAT+ to read the full story…

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Documentation Vaccines 236

Express Pharma

JUNE 23, 2025

Most projects fail not in the lab, but in study design, regulatory interpretation, and documentation. Real example: Injectable in a glass vial We supported a vaccine company using Type I glass vials they assumed were inert. The reason? Include Toxicological Justification: Work with a toxicologist to evaluate and qualify extractables.

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Packaging Dosage Documentation Biosimilars 65

pharmaphorum

MAY 16, 2022

In 2020, USAID launched two policy documents to guide how the agency invests in digital infrastructure as part of its development and humanitarian assistance programmes: Digital Strategy and Vision for Action in Digital Health (aka Digital Health Vision).

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Documentation Vaccines 118

STAT

JANUARY 23, 2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.

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Documentation Vaccines 346

Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. The importance of using plain language in health communications is well-documented in literature.

Documentation 52

Documentation Communication Mayo Clinic Drug Development 52