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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. of participants.

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Allergic reactions prompt Moderna COVID vaccine pause in California

pharmaphorum

Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic. The clinic in question switched to another lot of Moderna vaccine after closing for a few hours.

Vaccines 136
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FDA approves first gene therapy for high-risk early bladder cancer

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours.

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AZ, J&J COVID-19 vaccine trials okay to restart in US

pharmaphorum

US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot. There are many possible factors that could have caused the event.”.

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With filing due soon, Moderna stakes a claim to the RSV vaccine market

pharmaphorum

Moderna is looking to make a swift dash to the finish line with its respiratory syncytial virus (RSV) vaccine candidate, based on the same mRNA technology as its COVID-19 shots, with a filing in with the FDA in the first half of this year. for placebo.

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STAT+: Pharmalittle: FDA holds rare second meeting over an ALS drug; U.S. to expand distribution for monkeypox vaccine

STAT

 Moving forward, the company will expand patient monitoring in the trial to watch for low magnesium levels, which had resulted in a serious adverse reaction in one study participant that led the FDA to suspend testing earlier this year.

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COVID-19: Booster Doses – Part 3

The Infectious Pharmacist

Pfizer vs. Moderna and a note on vaccine dosing and timing. You probably have read news reports about a preprint article stating that the Moderna vaccine appeared more effective than the Pfizer vaccine, at least several months after vaccination. Should I stick with the same mRNA vaccine I got for the first two doses?