STAT

OCTOBER 4, 2023

It’s the end of an era for a once-critical pandemic document: The ubiquitous white Covid-19 vaccination cards are being phased out. Now that Covid-19 vaccines are not being distributed by the federal government, the Centers for Disease Control and Prevention has stopped printing new cards. Read the rest…

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Vaccines Documentation 120

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.

Vaccines 125

Vaccines Documentation FDA 125

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 FDA Adverse Reactions 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 FDA 103

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.

Vaccines 119

Vaccines Adverse Reactions Documentation Labelling 119

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 FDA Documentation Immunization 105

Pharmaceutical Technology

MARCH 28, 2024

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

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Documentation Vaccines 113

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.

Vaccines 111

Vaccines Communication Immunization Documentation 111

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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FDA Documentation Vaccines 131

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 Immunization Documentation 98

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 Documentation Compounding FDA 108

STAT

OCTOBER 16, 2024

At the time, deaths from Covid-19 were surging, and no vaccine was available. But inside a UnitedHealth practice, the “#1 PRIORITY” became documenting older patients’ chronic illnesses to generate more revenue from the federal government, the emails show.

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Documentation Vaccines Insurance 145

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

Fierce Pharma

DECEMBER 1, 2023

Less than two weeks after documents were unsealed showing that Texas has accused Pfizer and manufacturer Tris Pharma of providing a compromised ADHD medicine to the state, Paxton has sued Pfizer for “unlawfully misrepresenting the effectiveness” of the company’s COVID-19 vaccine.

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Vaccines Documentation 78

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

BioPharm

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 FDA 52

Pharma Times

JULY 27, 2023

New HSCC document deems the UK’s vaccination position to be at risk - News - PharmaTimes

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Vaccines Documentation 49

pharmaphorum

MAY 3, 2022

. “From the beginning of the pandemic, we noted inequities in the way the US population was experiencing disease incidence – the cases of COVID and the access to testing, level of clinical services available, and, when the vaccine became available, differential levels of access to the vaccine,” Labrique says.

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Vaccines Documentation 105

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

NOVEMBER 10, 2021

After being hailed as a triumph of public-private drug development, Moderna’s partnership with the US government on its COVID-19 vaccine looks like it may descend into acrimony.

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Vaccines Documentation 105

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 102

DiversifyRx

MAY 9, 2024

Are you finally thinking of starting a vaccine program in your independent pharmacy? Adding vaccine administration to your list of pharmacy services is a great way to serve and protect your community while increasing your pharmacy’s visibility, revenue, and profit. Additional revenue Vaccinations can be a profitable service.

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Vaccines Health and Personal Care Stores Immunization Independent Pharmacies 52

pharmaphorum

DECEMBER 16, 2020

Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing its safety and rating its efficacy at 94.5%. Both vaccines will be provided free of charge to recipients.

FDA 98

FDA Vaccines Documentation 98

Omnicell

JANUARY 10, 2023

Howard Montgomery, MS, RPh Director, Clinical Consulting, Omnicell The biggest vaccination campaign in history is now underway and scaling fast. The vaccine rollout brings unique logistical challenges, especially for health system pharmacy as they need to manage inventory across multiple, diverse locations.

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Vaccines Omnicell Documentation Compounding 52

pharmaphorum

JULY 12, 2022

Researchers in the US have started a clinical trial of a vaccine against Nipah virus, a serious infection caught from animals that has a fatality rate of between 40% and 70%, developed by mRNA specialist Moderna. “The need for a preventive Nipah virus vaccine is significant,” he added.

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Vaccines Documentation Immunization 52

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 FDA Immunization Documentation 52

European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

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Packaging Vaccines Documentation FDA 105

pharmaphorum

JULY 6, 2021

” Life Sciences Minister Nadhim Zahawi said late last month that the Vision document is due to be published over the summer and will form part of the treasury’s Plan for Growth agenda, published at the budget in March. Globally, the biotech sector raised just over £9.4 billion from venture and private sources, up from £7.6

Documentation 141

Documentation Vaccines 141

pharmaphorum

MARCH 19, 2021

The chip is loaded with binding agents produced by Avacta and Aptamer that detect Spike proteins found on the surface of the virus, which are also the targets for many of the vaccines available and under development.

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Documentation Vaccines 145

Omnicell

SEPTEMBER 5, 2022

Danny Sanchez VP and General Manager, EnlivenHealth® As news emerged about the positive COVID-19 vaccine trial results from Pfizer and its German partner BioNTech, the attention turned to how the vaccine would be distributed and administered to 330 million Americans.

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Vaccines Documentation Communication 52

pharmaphorum

FEBRUARY 19, 2021

Two researchers have suggested that the second dose of Pfizer and BioNTech’s COVID-19 vaccine could be delayed, as this would increase the number of people that can be protected while supplies are limited without compromising its efficacy. . Feature image copyright BioNTech SE 2020, all rights reserved.

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Vaccines Immunization Documentation FDA 72

pharmaphorum

FEBRUARY 25, 2021

Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the requirements for emergency use authorisation. S vaccine – developed by J&J’s Janssen Biotech unit – is “consistent” with recommendations in its EUA guidance for COVID-19 vaccines.

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FDA Vaccines Documentation 59

pharmaphorum

JULY 14, 2022

The European Commission’s failure to reveal text messages between president Ursula von der Leyen and Pfizer chief executive Albert Bourla on COVID-19 vaccine procurement has earned it a formal 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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Documentation Vaccines 52

pharmaphorum

NOVEMBER 16, 2022

The health technology assessment (HTA) agency has turned down five other COVID-19 therapies, notably AstraZeneca’s Evusheld (tixagevimab plus cilgavimab) – which patient organisations in the UK have been clamouring for access to, as it is an alternative to vaccinations for some vulnerable patient groups. The #cev struggle is real.

Vaccines 105

Vaccines Documentation 105

pharmaphorum

AUGUST 16, 2021

Nearly every element of the clinical trial design, data collection, analysis and approvals has been shortened and this helped ensure the swift rollout of safe and effective vaccines.”. Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials.

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Documentation Vaccines Packaging Pharmaceutical Companies 98

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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FDA Documentation Vaccines 95

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