This week, the FDA authorized booster doses of COVID-19 vaccines of
Pfizer ( PFE Quick Quote PFE - Free Report) / BioNTech ( BNTX Quick Quote BNTX - Free Report) and Moderna for use in all adults while the Committee for Medicinal Products for Human Use (“CHMP”) recommended Pfizer/BioNTech’s COVID-19 jab for young children in Europe. The European Commission (“EC”) approved Roche’s ( RHHBY Quick Quote RHHBY - Free Report) Gavreto for a lung cancer indication. Health Canada granted full approval to J&J’s ( JNJ Quick Quote JNJ - Free Report) COVID-19 vaccine, making it the first full approval for the vaccine globally. Merck ( MRK Quick Quote MRK - Free Report) stopped dosing in a mid-stage HIV study. Recap of the Week’s Most Important Stories The FDA expanded emergency use approval (EUA) of Pfizer/BioNTech and Moderna’s COVID vaccine boosters to FDA Approves COVID-19 Boosters for All Adults: allow its use in all adults. The FDA has authorized a single booster shot of either the Moderna or Pfizer/BioNTech vaccine to all individuals 18 years of age and older after completion of primary vaccination with either of the three approved/authorized COVID-19 vaccines made by J&J, Pfizer and Moderna. Earlier in September, the FDA had granted EUA to a booster dose of Pfizer/Moderna’s vaccines for individuals 65 years and older and those in high-risk groups but did not approve it for the entire population for which the companies were seeking approval.
The Centers for Disease Control and Prevention also endorsed the recommendation of its Advisory Committee on Immunization Practices to allow the booster doses for all adults who got Pfizer/Moderna’s vaccine at least six months after their second shot.
The European Medicines Agency’s CHMP gave a positive opinion recommending expanded use of Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty, in children five to under 12 years of age in Europe. The CHMP’s recommendation will be reviewed by the EC, which should soon make its decision on the same. If approved, Comirnaty will be the first vaccine to be approved for administration in this age group in Europe. The dose of Comirnaty for kids in this age group will be lower than that used in people aged 12 and above (10 µg compared with 30 µg). CHMP Recommends Pfizer’s Comirnaty for Kids:
Comirnaty was approved for administration in children of this age group in the United States in October. The approval in the United States and CHMP’s recommendation was based on data from a phase II/III study, which showed that its COVID-19 vaccine had a favorable safety profile and generated robust immune responses and a vaccine efficacy rate of 90.7% in kids of this age group.
Pfizer signed a
contract agreement with the U.S. government to supply 10 million treatment courses of its investigational oral COVID-19 drug, Paxlovid, subject to regulatory authorization from the FDA. Pfizer has filed EUA seeking approval of Paxlovid. Per the agreement with the U.S. government, Pfizer will deliver the contracted 10 million treatment courses of Paxlovid later this year, if authorized by the FDA, and conclude in 2022. In exchange, the company will receive $5.29 billion from the U.S. government.
Pfizer also announced that the EC has granted approval to its JAK inhibitor drug, Xeljanz (5 mg twice daily) for the treatment of active ankylosing spondylitis (AS) for patients who have responded inadequately to conventional therapy.
With the latest approval, Xeljanz is now approved for five indications in the EU, rheumatoid arthritis (RA), active psoriatic arthritis (PsA), moderately to severely active ulcerative colitis (UC), polyarticular JIA and juvenile PsA and now AS.
Merck has stopped dosing in the phase II IMAGINE-DR clinical study, which is evaluating a once-weekly investigational combination of MK-8507 and islatravir (ISL) for the treatment of people living with HIV-1. The dosing has been stopped at the recommendation of an external Data Monitoring Committee (eDMC). In the study, decreases in total lymphocyte and CD4+ T-cell counts were observed in study participants randomized to receive ISL+MK-8507, which the eDMC determined was related to treatment with the combination of ISL+MK-8507. The most significant decreases were seen in the arms of the study receiving the highest doses of MK-8507 (200 mg and 400 mg). Merck Stops Dosing in Phase II HIV Study:
Merck also announced that FDA has granted approval to Keytruda for the adjuvant treatment of renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney) or following nephrectomy and resection of metastatic lesions. This approval was based on data from the pivotal phase III KEYNOTE-564 study, which showed that Keytruda given after surgery led to a statistically significant and clinically meaningful improvement in disease-free survival compared to placebo in such patients.
The European Commission Approves Roche’s Lung Cancer Drug: European Commission granted conditional marketing authorization to Roche’s Gavreto as a monotherapy for the treatment of RET fusion-positive advanced NSCLC. Gavreto is approved in the United States for the treatment of adults with metastatic RET fusion-positive NSCLC and the treatment of adult and pediatric patients 12 years of age and older with advanced RET-altered thyroid cancers. Health Canada granted full approval to J&J’s COVID vaccine, making it the J&J’s COVID Vaccine Wins Full Approval in Canada: first full approval for the vaccine globally. J&J’s vaccine is presently approved for emergency use in some countries, including the United States. The full approval in Canada was based on initial data from the phase III ENSEMBLE study, which showed that the vaccine was 85% effective overall in preventing severe disease. It also offered protection against COVID-19-related hospitalization and death as well as against different variants.
The NYSE ARCA Pharmaceutical Index declined 1.5% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, AbbVie rose the most (1.3%) while Roche declined the most (3.0%)
In the past six months, Lilly recorded the maximum gain (31.5%) while Novartis declined the most (7.4%)
(See the last pharma stock roundup here:
JNJ to Spin Off Consumer Unit, PFE Eyes EUA for COVID Pill) What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.