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Cheeks were flushed all day. About an hour ago my face started to swell up 👎. Took two Benadryl. Then started going down but not gone. Boo. My body seems not to like infusions of stuff. #Pemgarda

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Invivyd and Leading Researchers Form SPEAR (Spike Protein Elimination and Recovery) Study Group to Assess the Effects of Monoclonal Antibody Therapy for Long COVID and COVID-19 Post-Vaccination Syndrome | Invivyd SPEAR Study Group initiated following multiple, independent reports of substantial clinical benefit associated with PEMGARDA ® (pemivibart) therapy among people with Long COVID SPEAR Study Group collaborators Drs. Michael Peluso, Amy Proal, and David Putrino are key thought leaders in the clinical

🚨 Big news for Long COVID warriors! 🧬 Invivyd launches the SPEAR Study Group to explore monoclonal antibody treatments targeting persistent spike protein. Hope is on the horizon! 🌟 #LongCOVID #PEMGARDA #ClinicalTrials #MedSky #HopeIsComing 💉

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The assay can also guide the application of immunotherapy drugs, including Pemgarda or Evusheld, to ensure appropriate patient selection for targeted treatment. #Pemgarda #Evusheld

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Have you seen this petition yet? Urge HHS Secretary Robert F Kennedy Jr to Expedite Approval of Pemgarda for Long COVID

Dring er bij minister v Volksgezondheid Robert F. Kennedy Jr. op aan de goedkeuring van #Pemgarda voor LongCOVID patiënten te versnellen.

Als er 1 groep mensen is waarvan we 100% zeker zijn dat ze ernstig ziek worden van een covid infectie zijn zij het.

Help ons!

chng.it/6tVyyFVbm9

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Photo of David Chadwick
David Chadwick 
Liberal Democrat Spokesperson (Wales)
To ask the Secretary of State for Health and Social Care, whether he has had discussions with NICE on the potential use of PEMGARDA to protect clinically vulnerable people against covid-19 in emergency situations.

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Hansard source (Citation: HC Deb, 26 March 2025, cW)

Photo of David Chadwick David Chadwick Liberal Democrat Spokesperson (Wales) To ask the Secretary of State for Health and Social Care, whether he has had discussions with NICE on the potential use of PEMGARDA to protect clinically vulnerable people against covid-19 in emergency situations. Tweet Share Hansard source (Citation: HC Deb, 26 March 2025, cW)

Photo of Karin Smyth
Karin Smyth
Minister of State (Department of Health and Social Care)

It is critical that medicines used in the United Kingdom are safe and effective and as such, medicines cannot be marketed in the UK without a marketing authorisation. These are granted by the Medicines and Healthcare products Regulatory Agency (MHRA) which assesses all medicines with regard to their quality, safety, and efficacy. Pemivibart, sold under the brand name Pemgarda, for use in the prophylaxis of COVID-19 does not yet have a marketing authorisation. It is the responsibility of the company to apply to the MHRA for the relevant marketing authorisation. Should an application for it be received, the MHRA will consider this accordingly.

In England, the National Institute for Health and Care Excellence (NICE) considers all newly licenced medicines, those that have received a marketing authorisation, to determine whether they represent a clinically and cost-effective use of National Health Service resources. If the manufacturer of Pemgarda seeks a licence from the MHRA, then the NICE may consider it through its technology appraisal programme.

Photo of Karin Smyth Karin Smyth Minister of State (Department of Health and Social Care) It is critical that medicines used in the United Kingdom are safe and effective and as such, medicines cannot be marketed in the UK without a marketing authorisation. These are granted by the Medicines and Healthcare products Regulatory Agency (MHRA) which assesses all medicines with regard to their quality, safety, and efficacy. Pemivibart, sold under the brand name Pemgarda, for use in the prophylaxis of COVID-19 does not yet have a marketing authorisation. It is the responsibility of the company to apply to the MHRA for the relevant marketing authorisation. Should an application for it be received, the MHRA will consider this accordingly. In England, the National Institute for Health and Care Excellence (NICE) considers all newly licenced medicines, those that have received a marketing authorisation, to determine whether they represent a clinically and cost-effective use of National Health Service resources. If the manufacturer of Pemgarda seeks a licence from the MHRA, then the NICE may consider it through its technology appraisal programme.

Lib Dem, David Chadwick asked if the DHSC has discussed using #Pemgarda to protect Clinically Vulnerable people in emergencies.

Minister confirms: No authorisation yet. No application made.

The CV community is still waiting... @invivyd.bsky.social

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COVID Continues to Pose Life-Threatening Risk to Millions of Americans <p>CBS News Health Watch recently reported that a new wave of summer COVID infections is on the rise and that the Centers for Disease Control and Prevention is tracking the rapidly mutating and spread...

#COVID19 Still Poses Life-Threatening Risk to Millions of Americans, current dominant #variant KP.3 is not only spreading but also highly contagious, making it a serious concern. Note NEW EUA for #Pemgarda, a groundbreaking #MonoclonalAntibody medication.
www.thewellnews.com/opinions/cov...

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Weiss jemand mehr, wie Einreichungen Europa geplant sein könnte? Nach #Evusheld wieder ein Hoffnungsschimmer mit #Pemgarda für ein bisschen mehr Schutz für #Immunsupprimierte

#CovidIsNotOver

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