Pfizer $PFE Stock Up On EUU Approval of Paxlovid For COVID

  • Post category:Biotechnology
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Pfizer PFE stock ran up 2.6% in morning trade on December 16, 2021, after the EMA said Pfizer’s Paxlovid could be used to treat COVID.

EMA Issues Advice for Potential Early Use of Pfizer’s Novel COVID-19 Oral Antiviral Candidate

On December 16, 2021, Pfizer Inc. (NYSE: PFE) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued advice on the use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), stating that PAXLOVID can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. The CHMP also recommend that PAXLOVID should be administered as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms. The EMA issued this advice under Article 5(3) of Regulation 726/2004 to support authorities of European Union (EU) Member States who may decide to allow the supply and use of PAXLOVID, for example in emergency use settings, prior to EU conditional marketing authorization. PAXLOVID is currently not authorized for use in the EU.

“The CHMP’s advice signifies the strength of our data for PAXLOVID in the treatment of high-risk adults diagnosed with COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “COVID-19 continues to take lives at an unprecedented pace globally and exacts a devastating toll on health care systems. If authorized, PAXLOVID has the potential to help save lives and reduce hospitalizations. We look forward to working with the EMA and other regulatory agencies worldwide to bring this potential treatment to patients as quickly as possible.”

The CHMP based their advice on positive results from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis, which enrolled non-hospitalized adults with confirmed COVID-19 who are at increased risk of progressing to severe illness. The data demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death from any cause in patients treated with PAXLOVID compared to placebo within three days of symptom onset, with no deaths in the treatment group. Similar results were seen with those treated within five days of symptom onset. Treatment-emergent adverse events were comparable between PAXLOVID (19%) and placebo (21%), most of which were mild in intensity. Pfizer recently announced that results from the final analysis of the primary endpoint from all patients enrolled in EPIC-HR were consistent with the interim analysis, confirming robust efficacy and a similar safety profile.

Pfizer has also initiated rolling submission with the EMA for potential EU conditional marketing authorization of PAXLOVID. If authorized, PAXLOVID could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death. PAXLOVID is also being studied in adults at standard risk of progressing to severe illness, as well as in adults who have been exposed to the virus through household contacts.

PAXLOVID is an investigational SARS-CoV-2 protease inhibitor antiviral therapy. It was developed to be administered orally so that, if authorized or approved, it can be prescribed at the first sign of infection or at first awareness of an exposure – potentially helping patients avoid severe illness (which can lead to hospitalization and death) or disease development following contact – subject to the successful completion of the remainder of the EPIC clinical development program. Nirmatrelvir [PF-07321332], which originated in Pfizer’s laboratories, is designed to block the activity of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

EMA approves increase in manufacturing capacity for COVID-19 vaccines

On December 16, 2021, European Medicines Agency’s human medicines committee, or CHMP, has approved an additional manufacturing site for the production of COVID-19 vaccine Janssen (JNJ), developed by Janssen-Cilag International NV. The site, located in Marcy-l’Etoile, France, and operated by Sanofi Pasteur, will manufacture finished product. The site is expected to support the continued supply of COVID-19 Vaccine Janssen. The CHMP has also given a positive opinion for an increase in production of Spikevax, the COVID-19 vaccine from Moderna (MRNA), at the manufacturing site operated by ROVI Contract Manufacturing, located in Madrid, Spain.The increase in production includes a 50% scale-up of the batch size of the finished product and a second fill-and-finish line. These changes will allow the production of around 25 million additional doses of Spikevax every month to the European Union and to third countries through the COVID-19 Vaccines Global Access, or COVAX, initiative. An increase in production of the active substance of Comirnaty, the COVID-19 vaccine from BioNTech (BNTX)/Pfizer (PFE), at the manufacturing site operated by Wyeth BioPharma Division of Wyeth Pharmaceuticals, located in Andover, MA, USA, was also approved by the Committee. This increase in production capacity is expected to support the continued supply of Comirnaty in the European Union. These recommendations do not require a European Commission decision and the changes can become operational immediately. Source:

📺 VIDEO Pfizer CEO: Mistake to think Covid pill will replace vaccine

Pfizer CEO Albert Bourla says his company’s anti-viral pill to treat Covid-19 awaiting FDA approval could be a game-changer in fighting the pandemic, but cautioned that it should not replace vaccines because the goal is to not get infected by the coronavirus in the first place.

📈 Pfizer PFE Stock Technical Analysis

Pfe Stock

PFE stock has rising large players volume which is bullish. The long and short term trends are both positive. This is looking good! PFE is one of the better performing stocks in the Pharmaceuticals industry, it outperforms 95% of 257 stocks in the same industry. A new 52 week high is currently being made by PFE, which is a very good signal! However, this is in line with the S&P500, which is also trading near new highs. There is a support zone ranging from 52.77 to 53.63. This zone is formed by a combination of multiple trend lines and important moving averages in multiple time frames. Although PFE has an excellent technical rating, it does not offer a high quality setup at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first. Click here to sign up for email alerts on when PFE stock is a good entry.

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