Tag: vaccines

May 26, 2023

Pfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. […]

May 25, 2023

Americans with COVID-19 have been taking Paxlovid since it was approved under emergency use in late 2021. Today, the U.S. Food and Drug Administration granted full approval to the drug. This approval will allow drugmaker Pfizer to sell the medication […]

May 23, 2023

The Vaccines and Related Biological Products advisory committee (VRBPAC) voted unanimously that the available data supported the efficacy of RSVpreF in helping to protect against the complications of RSV in infants from birth to six months of age. The committee […]

May 19, 2023

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. […]

May 18, 2023

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 […]

May 10, 2023

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 […]

May 5, 2023

Moderna, Inc., a provider of messenger RNA (mRNA) therapeutics and vaccines, entered into a long-term agreement with Ontario-based Novocol Pharma, a sterile injectable contract development and manufacturing organization (CDMO), to perform aseptic fill-finish, labelling and packaging of mRNA respiratory vaccines […]

May 5, 2023

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 […]

May 3, 2023

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 […]

May 2, 2023

FDA released a new draft guidance that provides recommendations aimed at sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. This specific guidance refers to a DCT as a clinical […]

April 21, 2023

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 […]

April 20, 2023

UC Davis Health researchers have dosed the second participant in their clinical trial looking to identify a potential cure for HIV utilizing CAR T-cell therapy. The novel study uses immunotherapy. It involves taking a patient’s own white blood cells, called […]

April 19, 2023

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 […]

April 18, 2023

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 […]

April 12, 2023

Meissner, a company focused on advanced microfiltration and therapeutic manufacturing systems, announced on April 6, 2023 that it will invest nearly $250 million in a new manufacturing facility in Athens-Clarke County, Ga. The new facility will be located at the […]

April 11, 2023

Curevo Vaccine, a privately held clinical-stage biotechnology company dedicated to reducing the burden of infectious disease by developing safe and highly effective vaccines, announced Guy De La Rosa has joined the company as its new chief medical officer. “The Curevo […]

March 29, 2023

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 […]

March 27, 2023

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 […]

March 23, 2023

Moderna, flush with more than $18 billion in cash at the end of 2022 from revenue generated by its COVID-19 vaccine, has been reinvesting some of that money in search of its next growth engine. This year, the company is […]

March 15, 2023

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 […]