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.

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STAT

FEBRUARY 12, 2024

We accept all manner of confidential communications and secret dossiers … New diabetes and weight loss drugs may benefit patients undergoing hip replacement without adding to complication risks , Reuters reports, citing preliminary data released at a meeting of orthopedic surgeons. Meanwhile, here are a few tidbits to digest.

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Pharmacy Times

AUGUST 10, 2023

Approximately 57% of individuals who were shown a flowchart of the FDA vaccine approval process were very or somewhat likely to recommend a respiratory syncytial virus vaccine to a pregnant family member or friend compared to only 40% of those who were not shown the process.

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Pharma Times

NOVEMBER 8, 2023

Communicable diseases account for 50% of all deaths in LMICs - News - PharmaTimes

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Pharmaceutical Technology

MARCH 20, 2023

RVAC Medicines has announced a research collaboration with the University of Pennsylvania (Penn) for the discovery and development of mRNA vaccines. The mRNA vaccine candidates will help reduce the chances of autoimmune responses that might lead to allergic conditions or serious autoimmune diseases.

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pharmaphorum

MAY 19, 2022

The likelihood of long COVID symptoms was found to decrease after COVID-19 vaccination, and evidence pointed to an even greater improvement after a second dose. However, the authors say more data is needed before vaccination can be considered a treatment for the condition.

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Pharmacy Times

NOVEMBER 16, 2022

Rohde, PhD, MS, SM(ASCP)CM, SVCM, MBCM, FACSc; review what encompasses a bivalent vaccine and give their perspective on how to communicate the role of the vaccine in optimizing protection for patients. Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP; Jacinda Abdul-Mutakabbir, PharmD; and Rodney E.

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pharmaphorum

NOVEMBER 19, 2020

Amid the turmoil and the race to not only find a vaccine but also help to care for those who are battling the long-term effects of COVID-19, healthcare organisations need to sharpen their communication skills. Good, empathetic design allows the science to shine.

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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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Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. The post GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA appeared first on Pharmaceutical Technology.

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Pharmafile

JANUARY 23, 2023

Indian biotech company Bharat Biotech plans to launch its new intranasal COVID-19 vaccine iNCOVACC on the 26 January 2023 ‒ the vaccine is the first of its kind to be developed in India. read more

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Pharmafile

MARCH 2, 2023

Yesterday, GSK shared that an advisory committee from the FDA voted in support of its respiratory syncytial virus (RSV) vaccine candidate for older adults. This support is ahead of an official FDA approval for the company’s vaccine. GSK has shared that a final decision is expected to be made by the FDA ahead of the 3 May. read more

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Digital Pharmacist

AUGUST 21, 2023

The most effective preventive measure against the flu is getting an annual flu vaccine. Getting Vaccinated for the Flu The CDC says ideally, everyone who is eligible for a flu vaccine should be vaccinated by the end of October – the ideal time to get vaccinated being September or October.

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pharmaphorum

JANUARY 31, 2022

It is becoming increasingly important for people all over the world to understand the importance of vaccines and to have access to the vaccines they need – especially with digital innovation driving new vaccine development. Pfizer’s Josh Raysman, Saad Saeed, and Shanaya Deboo discuss vaccine awareness, access, and innovation.

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Pharmacy Times

NOVEMBER 10, 2022

Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP, leads a discussion on the challenges subvariants of SARS-CoV-2 present in terms of vaccination and approaching optimal communication to the public surrounding vaccination.

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pharmaphorum

JANUARY 20, 2021

Laboratory studies have confirmed that antibodies stimulated by Pfizer and BioNTech’s COVID-19 vaccine can neutralise the new, more transmissible variant of SARS-CoV-2 identified in the UK. That suggests that patients could get SARS-CoV-2 twice, but also that the current crop of vaccines may not be as effective.

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Pharmafile

SEPTEMBER 9, 2022

A new malaria vaccine could be pivotal in the fight against the deadly disease. This vaccine has been developed by members of the University of Oxford team behind the AstraZeneca COVID-19 jab. read more.

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Eye on FDA

DECEMBER 1, 2020

In my last posting on preparedness for a post-vaccination world I touched on some of the questions facing employers in general – policy questions that should be considered now for the eventualities of later. COVID-19 has cast a particularly harsh light on this fact where minorities in the U.S.

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Pharmaceutical Technology

JUNE 8, 2023

Gritstone bio has reported interim results from an ongoing Phase 1 study evaluating the company’s self-amplifying mRNA (samRNA) vaccine as a boost against Covid-19 (CORAL-BOOST). The Phase I CORAL-BOOST dose-escalation trial (NCT05148962) evaluated Gritstone’s samRNA candidate (GRT-R910) in previously vaccinated healthy older adults.

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Pharmaceutical Technology

MARCH 23, 2023

China’s National Medical Products Administration (NMPA) has granted emergency use authorisation (EUA) for CSPC Pharmaceutical Group’s messenger RNA (mRNA) vaccine, SYS6006, to treat Covid-19. With this regulatory approval, CSPC Pharmaceutical is claimed to be the first company to receive approval for providing an mRNA vaccine in the country.

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Pharmaceutical Technology

NOVEMBER 30, 2022

in a project agreement from the US government for developing self-amplifying RNA (saRNA) vaccine technology against advanced and emergent viral threats. Development of vaccines to Phase I trials under the five-year $59m prototype project comprises additional $28.4m in milestone payments.

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Pharmafile

APRIL 24, 2023

Sanofi has introduced a hepatitis A vaccine for children aged between one to 15 years old in the UK. The vaccine, inactive AVAXIM Junior, will consist of two doses injected intramuscularly six to 36 months apart. It is the most common form of viral hepatitis and the third most common vaccine-preventable infection among travellers.

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pharmaphorum

DECEMBER 17, 2020

Tik Tok is unlikely to spring to mind as a source of reliable information about complex issues, but scientists are using it to fly the flag for COVID-19 vaccines and other health topics. When we talk about vaccines as health professionals, people who are vehemently anti-vaccine can take it out of context for their agenda.

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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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Pharmacy Times

JULY 22, 2022

Pharmacists discuss the impacts of inaccuracy on vaccine hesitancy and offer communication strategies for conversations with patients.

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pharmaphorum

MARCH 4, 2021

Germany has decided that AstraZeneca’s COVID-19 vaccine should be approved for use in the over-65s after all, reversing its earlier restriction in that age group. . France has said the vaccine can be used in people aged up to 74, rather than the entire over 65s age group. million doses unused.

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Pharmafile

DECEMBER 23, 2022

BioNTech has announced the start of its new first-in-human phase 1 trial for BNT165b1, a candidate from its programme which aims to develop a multi-antigen malaria vaccine.

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Express Pharma

JUNE 20, 2023

The vaccine efforts of the COVID-19 pandemic highlighted our knowledge about gaps in the immune system. Finally, public engagement in research has to be sought through informal group sessions communicating the purpose of the human research in plain language.

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Pharmafile

APRIL 19, 2023

The FDA has announced its amendment of the emergency use authorisations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines in an attempt to simplify the vaccination programme. These amendments mean that: read more

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Pharmafile

APRIL 28, 2023

Pfizer has announced that the US Food and Drug Administration (FDA) has approved its PREVNAR 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease (IPD) in infants and children from six weeks to 17 years of age. read more

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pharmaphorum

MARCH 18, 2021

The World Health Organization has backed the safety of the Oxford University/AstraZeneca vaccine ahead of a key announcement from European safety experts later today. Several major European countries including Germany, Italy and France have temporarily suspended use of the vaccine amid fears that it could be linked to blood clots.

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Pharmafile

APRIL 27, 2023

GSK has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has shared a positive opinion on its respiratory syncytial virus (RSV) vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults over the age of 60. read more

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Pharmacy Times

APRIL 27, 2023

The analysis, published in Nature Communications, demonstrates glycan trimming also keeps the antibody response away from immunodominant glucan holes and patches.

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Pharmafile

DECEMBER 9, 2022

Pfizer has announced that the FDA has accepted its application for a respiratory syncytial virus (RSV) vaccine for older adults, with the FDA expected to come to a decision by Spring 2023. The FDA will review the application under the priority review programme, meaning the approval timeline should be reduced by four months. read more.

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Pharmafile

FEBRUARY 20, 2023

Valneva and Pfizer have seen their Lyme disease vaccine study cut down after some clinical trial sites were revealed to be not adhering to Good Clinical Practice (GCP) standards. Almost half of the trial’s participants will be withdrawn following these GCP violations. read more

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Pharmaceutical Technology

DECEMBER 21, 2022

This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure. Additionally, the centre is anticipated to have to capacity to make up to 250 million doses of vaccines per year.

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Pharmafile

DECEMBER 15, 2022

The two Ebola vaccines developed by Johnson & Johnson and Merck appeared successful according to two studies: they both produced virus-fighting antibodies after 14 days which appear to remain detectable at various levels for at least a year. The jabs also seem to be safe in both children and adults. read more.

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