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Pfizer (PFE) Recalls Hypertension Drug Due to Impurities

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Pfizer (PFE - Free Report) announced that it is voluntarily recalling some lots of its hypertension medicines due to the presence of a nitrosamine, N-nitroso-quinapril. Nitrosamines are carcinogens that may produce cancer in some human organs and tissues if present in water and food at above acceptable levels.

Pfizer is recalling six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets. While Accuretic tablets are distributed by Pfizer, authorized cheaper versions of the drug, quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide, are distributed by Greenstone.

Nitrosamines are impurities, which are present in water and food items and people are exposed to them. However, if these impurities are present above acceptable levels and people are exposed to them over the long term, they may increase the risk of cancer. The recalled product lots had been distributed to wholesalers and distributors in the United States and Puerto Rico from November 2019 to March 2022.

Pfizer’s stock is down 7.5% this year so far against an increase of 3.4% for the industry.


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In another news, the FDA announced that it would hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Apr 6 to discuss the need for future boosters of authorized COVID-19 vaccines. The panel of experts will not cast any vote at the meeting nor will it discuss any product-specific applications. 

Last week, Pfizer and partner BioNTech (BNTX - Free Report) applied to the FDA for Emergency Use Authorization (EUA) for an additional or “fourth” booster dose of their COVID-19 vaccine for adults 65 years of age and older. The shot can be taken by any individual who has received the third booster of any of the authorized or approved COVID-19 vaccines.

Pfizer and BioNTech’s booster dose or “third dose” was granted emergency approval by the FDA in December for all adults 18 years of age and older, following the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. Later, the EUA was extended to allow its use in individuals 16 and 17 years of age and thereafter in adolescents 12 to 15 years of age.

Among other COVID-19 vaccine makers, Moderna (MRNA - Free Report) also announced this month that it has filed a regulatory application with the FDA to amend the company’s existing EUA to allow a “fourth” dose or second booster dose of its COVID vaccine in adults aged 18 years and above.

The first booster dose of Moderna’s vaccine has been granted EUA for use in all adults in the United States at least six months after the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

Per Moderna, the reason for seeking approval for the second booster dose in the 18 years and older age bracket is to provide flexibility for the healthcare authorities to determine the appropriate use of the second booster dose of its COVID-19 vaccine in relevant patient groups.

We remind investors that the COVID-19 vaccines developed by both Moderna and Pfizer/BioNTech are based on mRNA technology.

A booster shot of J&J’s (JNJ - Free Report) adenovirus-based single-shot COVID-19 vaccine has EUA for adults aged 18 and older at least two months after the primary vaccination with its vaccine or with Pfizer or Moderna’s two-shot mRNA COVID-19 vaccine regimen. J&J’s has not yet applied for authorization of a second booster dose.

Pfizer has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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