Pharmacy Times

SEPTEMBER 14, 2023

Compared with COVID-19 vaccination alone, recent study findings show health care workers who received both a COVID-19 booster and influenza vaccinations did not have lower immune response or more frequent adverse events.

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Vaccines Immunization 139

STAT

FEBRUARY 22, 2024

After a contentious dispute, Novavax has agreed to refund up to $400 million to the international organization that purchased Covid-19 shots as part of a global vaccination program, but found itself with vaccines that were no longer needed. But as demand dried up last year, the vaccine makers kept $1.4

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Vaccines 136

pharmaphorum

NOVEMBER 2, 2020

million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”. The post MHRA looks to AI to hunt for COVID-19 vaccine side effects appeared first on. The UK drugs regulator has awarded a £1.5

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Vaccines 145

Pharmaceutical Technology

NOVEMBER 12, 2024

The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.

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Vaccines FDA 104

pharmaphorum

JANUARY 15, 2021

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.

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Vaccines Immunization FDA 119

pharmaphorum

MAY 10, 2021

A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot. . It is also asking for similar data from Moderna, which manufacture a COVID-19 vaccine that like Comirnaty is based on mRNA.

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Vaccines Labelling Immunization 122

pharmaphorum

SEPTEMBER 7, 2020

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. The vaccine also produced a T-cell response within 28 days, a secondary outcome.

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Immunization Vaccines Hospitals 107

European Pharmaceutical Review

MARCH 26, 2024

Moderna’s next-generation COVID-19 vaccine mRNA-1283 demonstrated a higher immune response against SARS-CoV-2, interim results from the company’s Phase III trial show. These findings were based on data comparing the treatment to mRNA-1273.222 (Spikevax ® ), Moderna’s licensed vaccine for the condition. Moderna’s Spikevax XBB.1.5-adapted

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Vaccines Immunization 110

pharmaphorum

SEPTEMBER 8, 2020

An EU consumer body has urged the European Commission to keep compensation measures in place for people who might be harmed in COVID-19 vaccine trials, responding to reports that the drug industry is lobbying to reduce liability. The BEUC is adamant that relaxing consumer protections even in such exceptional circumstances is a bad idea.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies 119

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

Pharmacy Times

APRIL 8, 2024

Investigators reported a low incidence of adverse events after simultaneous vaccination against seasonal influenza and respiratory syncytial virus.

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Vaccines 107

pharmaphorum

MARCH 18, 2021

An EMA advisory committee’s review of AstraZeneca’s COVID-19 has concluded that there is no increase in the overall risk of blood clots with this vaccine. And because the vaccine is effective in preventing COVID-19 disease – which in itself is a cause of blood clots – it “likely reduces the risk of thrombotic events overall.”.

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Vaccines Immunization 105

European Pharmaceutical Review

NOVEMBER 3, 2022

GSK has announced the European Medicines Agency (EMA) has validated a marketing authorisation application (MAA) under accelerated assessment for its respiratory syncytial virus (RSV) vaccine for adults above 60. If approved, the vaccine could be the first vaccine to prevent RSV lower respiratory tract disease (LRTD) in older adults.

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Vaccines 105

European Pharmaceutical Review

AUGUST 2, 2023

A new COVID-19 vaccine has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA). Bimervax is now the ninth vaccine to be authorised by the UK’s independent medicines regulator to treat the virus. The vaccine demonstrated a strong immune response in the trial.

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Vaccines Immunization 98

Pharmaceutical Technology

JUNE 24, 2022

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain.

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Vaccines FDA 105

Pharmacy Times

APRIL 9, 2025

Monetary incentives to receive a COVID-19 vaccine at a public vaccination event may have invertedly turned away others from receiving a booster, emphasizing the importance of recognizing spillover in trials addressing vaccine hesitancy.

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Vaccines 73

Pharmaceutical Technology

AUGUST 17, 2022

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. This means that the vaccine works against multiple serotypes of the disease, she explains. A one-size-fits-all approach.

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Vaccines 119

pharmaphorum

FEBRUARY 8, 2021

China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical Products Administration (NMPA). Both of the vaccines, along with another experimental vaccine from Sinopharm, have been used in China’s vaccination programme.

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Vaccines Immunization 89

European Pharmaceutical Review

AUGUST 30, 2022

It has highlighted the value of cutting-edge technologies, such as messenger RNA (mRNA) vaccines, and reinforced the industry’s understanding of the power of collaboration, including with contract partners such as contract development and manufacturing organisations (CDMOs). The rise of the nasal vaccine route.

Vaccines 119

Vaccines Immunization 119

European Pharmaceutical Review

JUNE 24, 2022

BioNTech has initiated construction of its first vaccine production facility in Africa. Together this network of factories will supply therapies and vaccines solely for people residing in member states of the African Union. The first set of manufacturing BioNTainers are expected to be delivered to the Kigali site by the end of 2022.

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Vaccines 96

European Pharmaceutical Review

JULY 13, 2022

Afrigen Biologics and the US National Institute of Allergy and Infectious Diseases (NIAID) have agreed to share technical expertise related to the development of next-generation messenger RNA (mRNA) vaccines and therapeutics. . Site visits are planned, with Afrigen expected to visit the VRC in Maryland, US, later this year. .

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Vaccines 95

STAT

OCTOBER 11, 2023

A company that Pfizer blamed for problems with a clinical trial testing a Lyme vaccine claims that regulators gave its procedures a clean bill of health during a recent inspection. Care Access served as a contract research organization and had enrolled about 3,000 patients in the late-stage trial.

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Vaccines 111

pharmaphorum

DECEMBER 16, 2022

Ben Hargreaves discovers why some have referred to the distribution of COVID-19 vaccines and treatments as a form of apartheid. There are already rules that dictate how countries should react against public health events that have the potential to traverse country borders, through the International Health Regulations.

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Vaccines Compounding Pharmaceutical Companies Pharmaceutical Companies 96

pharmaphorum

OCTOBER 27, 2020

Russia’s sovereign wealth fund has filed applications with the World Health Organization (WHO) that if approved could see the Sputnik V coronavirus vaccine backed for use in many countries around the world. The vaccine is based on two adenovirus vectors (Ad5 and Ad26) fused with the spike protein from the SARS-CoV-2 coronavirus.

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Vaccines 102

STAT

SEPTEMBER 6, 2023

In any event, there is work to be done, so as always, we have assembled a few items of interest for you. But the trials for the vaccines, which have been approved for adults 60 and older, included few participants 80 and older. But this is to be expected at this time of year, yes? Hope you have a successful day and conquer the world.

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Vaccines Nursing Homes 109

Pharmacy Times

JULY 2, 2024

Carrie Koenigsfeld, PharmD, FAPhA, highlights the main findings from the MATISSE trial, which evaluated the safety and efficacy of a non-adjuvanted RSV vaccine administered to pregnant women, presenting data that suggests the vaccine's effectiveness in preventing severe RSV in infants and discussing the observed adverse events in both mothers and infants. (..)

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Vaccines 65

Pharmafile

JANUARY 13, 2023

The FDA, along with Taiwanese medical institutions, have been evaluating Pfizer’s mRNA COVID-19 vaccine, questioning the CDC’s omission of known severe “adverse events of special interest” (AESIs) which appeared in post-vaccination studies. read more. read more.

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Vaccines FDA Communication 78

Fierce Pharma

JUNE 29, 2023

While Dupixent often steals the show, Sanofi isn’t sleeping on its vaccine franchise. | By 2030, Sanofi figures its immunizations could generate more than €10 billion in annual sales, the company said during a vaccines R&D event Thursday.

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Vaccines Immunization 77

Pharmacy Times

JUNE 25, 2024

Carrie Koenigsfeld, PharmD, FAPhA, reviews the pivotal findings from the AReSVi-006 trial that supported the approval of the adjuvanted RSV vaccine, including its efficacy in preventing lower respiratory tract RSV, associated adverse events, and important study limitations that may have influenced the results.

Vaccines 65

Vaccines 65

pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. Despite the fast review, the company insisted that the potential vaccine will be assessed according to the EMA’s normal standards for quality and safety.

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Vaccines FDA 85

pharmaphorum

NOVEMBER 17, 2020

Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by its ultra-cold storage requirements. The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials.

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Vaccines Immunization FDA 74

STAT

FEBRUARY 17, 2023

who had been enrolled in a Phase 3 study testing a vaccine against Lyme disease due to violations of good clinical practice at certain trial sites run by a third party , STAT says. … Pfizer discontinued a significant percentage of participants in the U.S.

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Vaccines 98

PioneerRx

DECEMBER 6, 2023

By now, you should know that patient care goes beyond prescriptions or vaccines. Sometimes, it goes beyond your pharmacy counter. Health journeys know no bounds.

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Vaccines Patient Care 52

Pharmaceutical Technology

APRIL 28, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of GSK’s respiratory syncytial virus (RSV) vaccine candidate for use in older adults. The vaccine candidate will be used to prevent lower respiratory tract diseases (LRTD) caused by RSV in adult patients aged 60 and above.

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Vaccines 64

Pharmafile

SEPTEMBER 8, 2023

Vaxart has announced topline data from its phase 2 challenge study which assessed its oral tablet monovalent norovirus vaccine candidate. The study met five out of its six primary endpoints and the vaccine was safe and well tolerated with no vaccine-related serious adverse events reported.

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Vaccines 59

Therapeutics Education Collaboration

MARCH 27, 2023

In episode 537, Mike and James invite Ricky Turgeon back to the podcast to talk about the impact of the influenza vaccination on cardiovascular events in both primary and secondary prevention. The best evidence is in secondary prevention. Tune-in to hear the numbers. The best evidence is in secondary prevention.

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Vaccines 40

pharmaphorum

MARCH 17, 2021

European regulators are “worried” that national regulators may have undermined trust in the Oxford University/AstraZeneca vaccine by temporarily suspending its use, despite central guidance to keep using it until a safety review has concluded later this week. . Politically motivated?

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Vaccines Labelling 64