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Category: Vaccines


FDA, Industry, Regulations, Vaccines

FDA advisers back maternal use of Pfizer RSV vaccine

May 19, 2023

Via: Biopharma Dive

The vaccine, if approved, would be the first available for protecting infants from a pathogen that each year kills hundreds of young children. It is one of a recent wave of drugmaker successes against the disease after decades of effort. […]


Industry, Vaccines

FDA Panel Backs First RSV Vaccine Given in Pregnancy

May 18, 2023

Via: Drugs.com

The first vaccine designed to protect infants against respiratory syncytial virus (RSV) by vaccinating their mothers during pregnancy has been backed by a panel of advisers to the U.S. Food and Drug Administration. On Thursday the independent committee of experts […]


Industry, Vaccines

FDA Approves First RSV Vaccine

May 10, 2023

Via: Biopharm International

FDA announced the approval of GSK’s Biologicals’ Arexvy, a respiratory syncytial virus (RSV) vaccine, on May 3, 2023. The vaccine is the first to be approved for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged […]


Industry, Vaccines

Science Reveals Cause of Rare Heart Trouble in Young Men Who Get COVID Vaccines

May 5, 2023

Via: Drugs.com

Researchers think they’ve figured out why the COVID vaccine causes heart inflammation in an extremely small number of teenage boys — and what might be done to avoid it. The second dose of COVID vaccine appears to promote a severe […]


Industry, Vaccines

FDA Approves First RSV Vaccine, Arexvy

May 3, 2023

Via: Drugs.com

The first vaccine for respiratory syncytial virus (RSV) has been approved by the U.S. Food and Drug Administration for use in seniors aged 60 and older. Arexvy, manufactured by GlaxoSmithKline (GSK), is expected to help prevent lower respiratory tract infections […]


FDA, Industry, Regulations, Vaccines

FDA clears Pfizer’s pneumococcal vaccine for infants and children

April 28, 2023

Via: Biopharma Dive

While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the U.S. each year. In response, Pfizer, Merck and others have worked to develop new shots that offer better protection, particularly […]


Industry, Vaccines

Pandemic Saw Rise in Mistrust of Childhood Vaccines Worldwide

April 21, 2023

Via: Drugs.com

While overall support for childhood vaccines remains strong, a new UNICEF report documents a significant decline in the public’s faith in the importance of these vaccines. Confidence in childhood immunizations dropped by up to 44 percentage points in some countries […]


Industry, Vaccines

Authorisation for Moderna and Pfizer/BioNTech’s bivalent COVID-19 vaccines simplified by FDA

April 19, 2023

Via: PMLiVE

The current bivalent vaccines, targeting the original and omicron BA.4/BA.5 strains, can now be used for all doses administered to individuals aged six months and older, including for an additional dose or doses for certain populations. Each vaccine now has […]


Industry, Vaccines

FDA favors single dose of updated COVID shots in shift to simplify vaccination

April 18, 2023

Via: Biopharma Dive

A single dose of either Pfizer’s or Moderna’s updated COVID-19 vaccines will be recommended in most cases moving forward, after the Food and Drug Administration on Tuesday updated its authorizations of the shots to simplify the recommended regimens. Adults or […]


Industry, Vaccines

WHO Experts Say Healthy Kids, Teens May Not Need More COVID Shots

March 29, 2023

Via: Drugs.com

New advice from the World Health Organization (WHO) says healthy children and teens may not need additional COVID-19 shots, though they may need to catch up on other routine vaccines. “The public health impact of vaccinating healthy children and adolescents […]


Clinical Trials, Industry, Research and Development, Vaccines

BioNTech Revenues Slide with Waning Demand for COVID-19 Vaccines

March 27, 2023

Via: Contract Pharma

4Q Revenues: €4.3 billion (-23%) 4Q Earnings: €2.3 billion (-28%) YTD Revenues: €17.3 billion (-9%) YTD Earnings: €9.3 billion (-8%) Comments: Results in the quarter and FY reflect lower demand for COVID-19 vaccines. Approximately 2 billion doses of COMIRNATY invoiced […]


Industry, Vaccines

Pfizer/BioNTech’s Omicron-adapted booster approved by FDA for young children

March 15, 2023

Via: PMLiVE

With this latest approval, children aged six months to four years who have completed their primary series with three doses of the companies’ original vaccine will be able to receive a 3µg booster dose of the bivalent vaccine after at […]


Industry, Mergers and Acquisitions, Vaccines

Merck signs $922m deal with Opko Health unit for Epstein-Barr vaccine candidate

March 9, 2023

Via: PMLiVE

The partnership will see both companies advance MDX-2201 to an Investigational New Drug application filing, after which Merck will be responsible for clinical and regulatory activities, as well as product commercialisation. In exchange, Opko will receive an upfront payment of […]


FDA, Industry, Regulations, Vaccines

FDA approves intramuscular administration of Merck’s MMRV vaccines

March 7, 2023

Via: PMLiVE

Despite having a long history in the US, the vaccines have previously only been administered via subcutaneous injection, which is given into the fatty tissue just under the skin. Now, healthcare professionals will have the option to choose to administer […]


Industry, Vaccines

Is an Allergy to a COVID Vaccine Always Real? Placebo Trial Casts Doubt

March 2, 2023

Via: Drugs.com

Allergic reactions to the Pfizer or Moderna COVID vaccines are very rare, and a new study questions whether many of those that do occur are even real. In a small new study of 16 people who said they’d experienced an […]


Industry, Vaccines

WHO announces recommended 2023-24 flu vaccines for northern hemisphere

March 1, 2023

Via: PMLiVE

National vaccine regulatory agencies and pharmaceutical companies will now use this guidance to develop, produce and license influenza vaccines for the following season. WHO organises consultations with an advisory group of experts twice a year to analyse influenza virus surveillance […]


FDA, Industry, Regulations, Vaccines

Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA

February 28, 2023

Via: Biopharm International

Moderna and Merck announced on Feb. 22, 2023 that their investigational personalized messenger RNA (mRNA) cancer vaccine, mRNA-4157/V940, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy Designation by FDA for the adjuvant treatment of patients with […]


FDA, Industry, Regulations, Vaccines

Moderna/Merck’s skin cancer therapy given FDA breakthrough therapy designation

February 24, 2023

Via: PMLiVE

The vaccine, mRNA-4157/V940, is designed to stimulate an immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumour, while Keytruda increases the ability of the body’s immune system to help detect and fight […]


Industry, Vaccines

Bavarian Nordic Acquires Travel Vaccines from Emergent Biosolutions

February 17, 2023

Via: Contract Pharma

Bavarian Nordic announced has entered into an agreement with Emergent BioSolutions, to acquire two marketed travel vaccines, Vivotif for the prevention of typhoid fever and Vaxchora against cholera as well as a Phase 3 vaccine candidate for the prevention of […]


Industry, Vaccines

Moderna Will Offer Free COVID Shots to Uninsured After Emergency Ends

February 16, 2023

Via: Drugs.com

American adults who have no health insurance or those who are underinsured will still be able to get free COVID vaccines from Moderna, even after government-purchased supplies run out, the company announced Monday. “Moderna’s COVID-19 vaccines will continue to be […]