ALiEM - Pharm Pearls

JANUARY 12, 2024

A 42-year old Bengali man with a history of hyperlipidemia presented to the Emergency Department with facial swelling, diffuse rash, renal insufficiency and proteinuria after receiving his COVID-19 vaccine (Moderna) booster dose. Erythema multiforme has been reported as a cutaneous reaction after the COVID-19 mRNA vaccine.

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Vaccines 130

STAT

SEPTEMBER 26, 2024

The decision is a stunning blow for a drug that was approved in 2019 and heralded as a new way to treat the inherited blood disorder. The High Court gave a mixed decision in July, ruling that one of Moderna’s two patents relating to the mRNA technology that underpinned its Covid-19 vaccine was invalid.

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Vaccines 245

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Stakeholders are invited to provide feedback on CDSCO draft guidance within 15 days from the notice’s issuance On May 29, 2024 a draft of the revised “Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines”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

NY Times

MAY 5, 2021

pharmaceutical industry, came out in favor of waiving intellectual property protections for coronavirus vaccines. The Biden administration, siding with some world leaders over the U.S.

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Vaccines Immunity Immunization 140

NY Times

DECEMBER 11, 2020

British health officials recommended that people with severe allergy reactions not be given the vaccine. Such reactions to vaccines are rare, even in people who have allergies to food or bee stings.

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Vaccines Immunity Immunization 140

ID Stewardship

MARCH 7, 2025

Although I have practiced in the area of infectious diseases pharmacy for quite a while now, measles has not been of much clinical relevance to me beyond MMR for routine vaccination. Vaccination is the best way to prevent measles This is an obvious one, but necessary to state right out the gate. MMR is given in 2 doses.

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Vaccines Immunization Immunity Communication 85

NY Times

DECEMBER 25, 2020

Until now, reports of severe reactions had been linked to the Pfizer vaccine. The patient, who has a severe shellfish allergy, recovered quickly with treatment.

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Vaccines Immunity Immunization 145

Pharmaceutical Business Review

AUGUST 14, 2024

The vaccine candidate is a virus-like particle (VLP)-based, adjuvanted vaccine designed for active immunisation against chikungunya virus (CHIKV) infection. The US regulator will make a decision on the vaccine approval under the Prescription Drug User Fee Act (PDUFA) by 14 February 2025.

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Vaccines 105

NY Times

AUGUST 20, 2021

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.

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Vaccines Immunity Immunization 145

NY Times

FEBRUARY 8, 2022

A crucial Johnson & Johnson plant has stopped making its Covid vaccine, though the company says it has millions of doses in inventory.

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Vaccines Immunity Immunization 143

NY Times

OCTOBER 9, 2021

Some poorer countries are paying more and waiting longer for the company’s vaccine than the wealthy — if they have access at all.

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Vaccines Immunity Immunization 145

STAT

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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Vaccines Bioethics Immunity Immunization 246

NY Times

AUGUST 3, 2021

The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.

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Vaccines Hospitals Immunity Immunization 145

Express Pharma

OCTOBER 16, 2024

Messenger ribonucleic acid (mRNA)-based innovator pharmaceuticals saw a staggering 800 per cent increase in licensing agreement deal values from 2019 to 2024YTD, driven by the remarkable success of mRNA vaccines during the COVID-19 pandemic. billion in 2030. Bristol Myers Squibb formed a multi-year, $1.87

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Vaccines Immunity Immunization Diabetes 104

NY Times

DECEMBER 15, 2020

will grant emergency authorization for a second coronavirus vaccine this week for millions of Americans. The positive review likely ensures that the F.D.A.

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Vaccines 145

European Pharmaceutical Review

JANUARY 26, 2024

A paper, published in Nature Chemical Biology has reported the first ‘free-from ‘tree’ production of a key vaccine ingredient sourced from the soapbark tree. Bioengineering vaccine adjuvants The paper explained: “QS-21 is a potent vaccine adjuvant currently sourced by extraction from the Chilean soapbark tree.

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Vaccines Compounding Immunity Immunization 98

NY Times

OCTOBER 21, 2021

The company said that in a study, boosters cut down the number of breakthrough infections among fully vaccinated people by more than 95 percent.

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Vaccines Immunity Immunization 145

NY Times

MARCH 4, 2021

Johnson & Johnson’s one-shot vaccine is allowing states to rethink distribution, even as health officials and experts worry some will view it as inferior.

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Vaccines Immunity Immunization 134

NY Times

JANUARY 26, 2021

President Biden said the amount of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to vaccinate nearly all Americans by the end of summer.

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Vaccines Immunity Immunization 124

European Pharmaceutical Review

AUGUST 15, 2022

According to Reuters , Kenya, Tanzania, Senegal and Cameroon have either run out of or are close to running out of vaccines to protect children against the deadly rotavirus infection following undisclosed “manufacturing challenges” at GSK. We are witnessing the largest sustained drop in childhood immunisation in a generation.

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Vaccines Communication 98

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

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

Digital Pharmacist

AUGUST 16, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for the JYNNEOS vaccine. Here is what you need to know about the monkeypox vaccine emergency use authorization. . JYNNEOS Vaccine Authorization Details . In this under 18 years old group, the JYNNEOS vaccine is administered subcutaneously.

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Vaccines 98

pharmaphorum

JULY 21, 2022

GSK’s former head of vaccines R&D – Dr Emmanuel Hanon – is heading up a new biotech called Vicebio that will go up against his former employer with a vaccine against respiratory syncytial virus (RSV) infections. ” The post Ex-GSK vaccine chief to lead new UK biotech Vicebio appeared first on. . ” He said.

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Vaccines Immunity Immunization 105

STAT

JULY 18, 2024

Merdad Parsey, who joined Gilead in 2019, will stay in his post until the first quarter of next year as the company looks for a successor. Gilead Europe’s second-highest court criticized the European Commission for a lack of transparency over Covid-19 vaccine contracts four years ago , Reuters writes.

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Documentation Vaccines 253

pharmaphorum

JULY 27, 2021

Flushed with the success of its COVID-19 vaccine, BioNTech has pressed the accelerator on the development of shots for other infectious diseases, and now plans to take malaria and tuberculosis candidates into the clinic next year. The post BioNTech’s mRNA vaccine drive now includes malaria, TB shots appeared first on.

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Vaccines 104

Express Pharma

OCTOBER 25, 2023

With influenza season well underway, vaccination campaigns are in full force in the northern hemisphere. This will reshape the global influenza vaccine market for the upcoming seasons, says GlobalData. Kurdach continues, “When the actual composition of vaccines will revert to trivalent formulations remains another question.

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Vaccines 98

pharmaphorum

NOVEMBER 29, 2021

The UK’s Vaccines Manufacturing and Innovation Centre (VMIC) – unveiled with fanfare by the government in 2018 – is rumoured to be up for sale. It was billed at the time as a key tool to accelerate the development of new and innovative vaccines to combat some of the world’s most prevalent diseases, from discovery to licensed product.

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Vaccines 105

pharmaphorum

DECEMBER 5, 2022

Valneva has moved a step closer to its goal of becoming the first company to file for approval of a vaccine against chikungunya virus in the US after reporting new clinical data today. Valneva estimates that the global market for vaccines against chikungunya could exceed $500 million annually by 2032.

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Vaccines 98

NY Times

JULY 1, 2021

The Pfizer and Moderna vaccines are safe and effective. Full approval from the F.D.A. will help stop the spread of Covid-19.

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Vaccines Immunity Immunization 117

NY Times

FEBRUARY 5, 2021

Covid cases fell dramatically and quickly among people who were vaccinated, Israeli studies found. It’s the strongest evidence yet that a robust vaccination program can tame the pandemic.

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Vaccines Immunity Immunization 111

NY Times

DECEMBER 18, 2020

The Food and Drug Administration authorized a second coronavirus vaccine for emergency use, clearing the way for millions more Americans to be immunized next week.

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Vaccines Immunity Immunization Nursing Homes 105

European Pharmaceutical Review

AUGUST 22, 2022

UNICEF has awarded GSK the first ever contract for the supply of a malaria vaccine. This vaccine rollout gives a clear message to malaria vaccine developers to continue their work because malaria vaccines are needed and wanted,” commented Etleva Kadilli, Director of UNICEF’s Supply Division. “We

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Vaccines 98

European Pharmaceutical Review

SEPTEMBER 28, 2023

There has been a steady stream of developments in the vaccine manufacturing space throughout 2023. A notable milestone was Moderna’s announcement in April that it had, following finalisation of a ten-year strategic partnership with the UK Government, commenced construction of its mRNA vaccine manufacturing technology centre.

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Vaccines Pharmaceutical Manufacturing 98

Pharma Times

NOVEMBER 4, 2021

The research paper, published in the Lancet and funded by Cancer Research UK, considered all cervical cancers diagnosed in England among women aged 20-64 between January 2006 and June 2019

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Vaccines 109

NY Times

JULY 12, 2021

Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.

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Vaccines Immunity Immunization 116

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 Biosimilars Documentation 108