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Coronavirus (COVID-19) Update: December 28, 2021

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Coronavirus (COVID-19) Update: December 28, 2021

December 28, 2021: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • On Monday, the U.S. District Court for the District of New Jersey entered a consent decree of permanent injunction that prohibits a New Jersey-based company from receiving or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.

    The complaint, filed by the Department of Justice on behalf of the FDA, alleged that Natural Solutions Foundation, an organization, and its two principals, Rima Laibow and Ralph Fucetola, violated the FD&C Act by selling unapproved and misbranded drugs intended to cure, mitigate, treat or prevent COVID-19.

    The defendants have a history of making unproven claims about their nano silver product. Greg Noonan, the FDA’s acting deputy director for the office of dietary supplement programs provided a quote to the Department of Justice.
  • The FDA updated the emergency use authorization (EUA) for COVID-19 convalescent plasma.  

    The update limits the authorization to the use of COVID-19 convalescent plasma with high titers of anti -SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment.

    These patients may be treated in outpatient or inpatient settings.  

    Additionally, to help assure the manufacture of high titer COVID-19 convalescent plasma, the revisions to the EUA revise acceptable tests and increase qualifying result cutoffs to be used for manufacturing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies.
  • The FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share new information regarding the impact of the SARS-CoV-2 omicron variant on antigen diagnostic tests.

    The update includes preliminary study results of some antigen tests using patient samples containing live virus. Early data suggest that antigen tests do detect the omicron variant but may have reduced sensitivity.

    The FDA will continue to collaborate with the National Institutes of Health’s (NIH) RADx program to further evaluate the performance of antigen tests using patient samples with live virus.
  • Testing updates:  
    • As of today, 419 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs).

      These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests and 42 antigen tests.

      There are 67 molecular authorizations and one antibody authorization that can be used with home-collected samples.

      There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 12 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
    • The FDA has authorized 23 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 747 revisions to EUA authorizations

      https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-december-28-2021

Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India

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Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India

Dec. 28, 2021: “Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, today announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant.

The vaccine will be manufactured and marketed in India by SII under the brand name Covovax™.

“No one is safe until everyone is safe, and today’s authorization marks a vital step for India, where additional vaccine options and millions of doses are needed in the country’s ongoing efforts to control the pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax.

“Novavax and SII will not rest in our partnership to deliver our vaccine to those in India and across the globe, as we work to protect the health of people everywhere.”

Because the vaccine is stored with standard refrigeration at 2° to 8° Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas.

“The approval of Covovax in India marks a significant milestone in strengthening our immunization efforts across India and LMICs,” said Adar Poonawalla, Chief Executive Officer, Serum Institute of India.

“We are proud to deliver a protein-based COVID-19 vaccine, based on Phase 3 clinical data demonstrating more than 90% efficacy and a favorable safety profile, to our nation.”

The Novavax/SII vaccine recently received EUA in Indonesia and the Philippines, as well as Emergency Use Listing (EUL) with the World Health Organization (WHO).

Novavax was also granted Conditional Marketing Authorization by the European Commission and EUL with the WHO for its vaccine, which will be marketed by Novavax as NuvaxovidTM. 

Novavax has also announced regulatory filings for its vaccine in multiple countries worldwide, while partners SK bioscience and Takeda have submitted regulatory filings in South Korea and Japan, respectively. 

Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

For additional information on Covovax, please visit the following websites in the coming days:

  • Central Drugs Standard Control Organization (India)
  • Serum Institute of India

Authorized Use of Novavax’ Covid-19 Vaccine in India
The Drugs Controller General of India (DCGI) has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.

Authorization in the U.S.
NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name Nuvaxovid has not yet been approved by the U.S. FDA.

Important Safety Information
Covovax is contraindicated in persons who have hypersensitivity to the active substance or to any of the excipients of this vaccine.

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Novavax’ COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses.

The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart.

The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. The current assigned shelf-life of the vaccine is 9 months. 

Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide.”

https://ir.novavax.com/2021-12-28-Novavax-and-Serum-Institute-of-India-Receive-Emergency-Use-Authorization-for-COVID-19-Vaccine-in-India

AstraZeneca and Ionis close agreement to develop and commercialise eplontersen

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AstraZeneca and Ionis close agreement to develop and commercialise eplontersen

December 29, 2021: “AstraZeneca has closed a global development and commercialisation agreement with Ionis Pharmaceuticals, Inc. (Ionis) for eplontersen, formerly known as IONIS-TTR-LRX.

The companies will jointly develop and commercialise eplontersen in the US, while AstraZeneca will develop and commercialise it in the rest of the world, except in Latin America.

Financial considerations
Under the terms of the agreement, the upfront payment from AstraZeneca to Ionis is $200m. AstraZeneca will make additional conditional payments of up to $485m following regulatory approvals.

It will also pay up to $2.9bn of sales-related milestones based on sales thresholds between $500m and $6bn, plus royalties in the range of low double-digit to mid-twenties percentage depending on the region.

The collaboration includes territory-specific development, commercial and medical affairs cost-sharing provisions.

The transaction will be funded with cash and is expected to be neutral to Core earnings in 2021.

It will be accounted for as an intangible asset acquisition, recognised initially at the upfront amount, with any potential future milestone payments capitalised into the intangible asset as they are recognised.

Ionis will continue to manufacture and supply eplontersen for the existing clinical studies and process qualification.

AstraZeneca will be responsible for commercial supply, with transition timing to be agreed by both parties.

AstraZeneca will book all sales generated under the agreement.

The transaction does not impact AstraZeneca’s financial guidance for 2021.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-and-ionis-close-eplontersen-deal.html

FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them

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FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them

December 23, 2021: “The U.S. FDA authorized the marketing of 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products (MRTPs), which help reduce exposure to, and consumption of, nicotine for smokers who use them.

These are the first combusted cigarettes to be authorized as MRTPs and the second tobacco products overall to receive “exposure modification” orders, which allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance. 

“Our mission is to find ways to stop tobacco-related disease and death.

We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.

“Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers.

If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.” 

The exposure modification orders specifically authorize the manufacturer to market “VLN King” and “VLN Menthol King” with certain reduced exposure claims regarding nicotine, including:

  • “95% less nicotine.”
  • “Helps reduce your nicotine consumption.”
  • “…Greatly reduces your nicotine consumption.”

When using any of the reduced exposure claims in the product label, labeling or advertising, the company must include, “Helps you smoke less.” The FDA also recommends that the labeling and advertising include the statement, “Nicotine is addictive. Less nicotine does NOT mean safer.

All cigarettes can cause disease and death.” The manufacturer is also required to label the packages with one of four warning statements for cigarettes as required by the Federal Cigarette Labeling and Advertising Act; for example, “Surgeon General’s Warning: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.” 

Despite today’s action, these products are not considered safe or “FDA approved.” There are no safe tobacco products, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product.

The exposure modification orders do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers.

These orders do not allow the company to market these products with therapeutic or cessation claims.

In the review of 22nd Century Group, Inc.’s MRTP applications, the FDA evaluated data from both the company and FDA testing and found that nicotine levels in tobacco and mainstream smoke of VLN cigarettes are at least 96% lower than the majority of marketed and market-leading conventional cigarette brands. 

Furthermore, the FDA’s behavioral and clinical pharmacology review found that by exclusively smoking cigarettes with the same or similarly reduced nicotine content as VLN cigarettes, consumers could reduce their exposure to nicotine by approximately 95%.

The data also showed it is reasonably likely that using these products reduces nicotine dependence, which is anticipated to lead to long-term reductions in exposure to the smoking-related toxicants associated with morbidity and mortality by reducing smoking.

Published studies have shown that significantly reducing the number of cigarettes smoked per day is associated with lower risk of lung cancer and death, with greater reductions in cigarettes per day resulting in less risk.

Additionally, as required for authorization, the FDA found that the applications supported consumer understanding of the claims that VLN cigarettes contain much lower levels of nicotine than other cigarettes.  

The authorization for these products requires the company to conduct postmarket surveillance and studies to determine whether the authorization criteria for these exposure modification orders continue to be met, including assessing use among youth. 

These products are also subject to the postmarket requirements and restrictions previously imposed in their December 2019 premarket tobacco product marketing granted orders.

In particular, to limit youth access to the products and to limit youth exposure to advertising and promotion, the marketing granted orders placed stringent restrictions on how the products are marketed–especially via websites and through social media platforms—by including requirements that advertising be targeted to adults of legal age to purchase tobacco products.

The company must request and receive authorization from the FDA to continue marketing the products with the same modified exposure information after the initial exposure modification orders expire in five years.

The FDA also may withdraw the initial, and any potential subsequent, exposure modification orders if the agency determines that, among other things, the orders are no longer expected to benefit the health of the population as a whole; for example, as a result of an uptake in use of the products by youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.

In reaching today’s determination, the FDA considered both the current legal status of menthol cigarettes and the available science demonstrating that these particular products could help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day.

The FDA is committed to moving forward with the rulemaking process to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars and remains on track to issue proposed rules in the spring of 2022.”

https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-tobacco-products-help-reduce-exposure-and-consumption-nicotine-smokers-who

FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19

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FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19

December 23, 2021: “The U.S. FDA issued an EUA for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.

Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth.

It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19.   

“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally.

Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.

“As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness.” 

Molnupiravir is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death.

The FDA urges the public to get vaccinated and receive a booster if eligible. Learn more about FDA-approved or -authorized COVID-19 vaccines.

Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating.

Molnupiravir is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules. Molnupiravir is not authorized for use for longer than five consecutive days. 

The issuance of an EUA is different than an FDA approval.

In determining whether to issue an EUA, the FDA evaluates the totality of the scientific evidence available and carefully balances any known or potential risks with any known or potential benefits of the product.

Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that molnupiravir may be effective for use as treatment of mild-to-moderate COVID-19 in certain adults when alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.

The agency has also determined that the known and potential benefits of molnupiravir, when used consistent with the terms and conditions of the authorization, outweigh the known and potential risks of the product.

There are no adequate, approved and available alternatives to molnupiravir for the treatment of COVID-19.

The primary data supporting this EUA for molnupiravir are from MOVe-OUT, a randomized, double-blind, placebo-controlled clinical trial studying molnupiravir for the treatment of non-hospitalized patients with mild to moderate COVID-19 at high risk for progression to severe COVID-19 and/or hospitalization.

Patients were adults 18 years of age and older with a prespecified chronic medical condition or at increased risk of SARS-CoV-2 infection for other reasons who had not received a COVID-19 vaccine.

The main outcome measured in the trial was the percentage of people who were hospitalized or died due to any cause during 29 days of follow-up.

Of the 709 people who received molnupiravir, 6.8% were hospitalized or died within this time period compared to 9.7% of the 699 people who received a placebo.

Of the people who received molnupiravir one died during the follow-up period compared to nine people who received placebo. Side effects observed in the trial included diarrhea, nausea and dizziness.

The safety and effectiveness of molnupiravir for the treatment of COVID-19 continue to be evaluated.

Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. Therefore, molnupiravir is not recommended for use during pregnancy.

Molnupiravir is only authorized to be prescribed to a pregnant individual after the prescribing healthcare provider has determined that the benefits of being treated with molnupiravir would outweigh the risks for that individual patient and after the prescribing health care provider has communicated the known and potential benefits and the potential risks of using molnupiravir during pregnancy to the pregnant individual.

Females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for four days after the final dose.

Males of reproductive potential who are sexually active with females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for at least three months after the final dose.

Questions and concerns about reliable birth control methods that are appropriate for use during treatment with molnupiravir, as well as how molnupiravir may affect sperm cells, should be directed at one’s healthcare provider. 

Under the EUA, fact sheets that provide important information about using molnupiravir in the treatment of COVID-19 as authorized must be made available to healthcare providers and to patients and caregivers.

These fact sheets include dosing instructions, potential side effects and information about who is able to prescribe molnupiravir.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain

Pfizer Receives FDA Authorization for Treatment of COVID-19

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Pfizer Receives FDA Authorization for Treatment of COVID-19

December 22, 2021: “Pfizer Inc. announced that the U.S.FDA has authorized the emergency use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

The treatment includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories, which was specifically designed to block the activity of the SARS-CoV-2 Mpro, an enzyme that the coronavirus needs to replicate. 

“Today’s authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world.

This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible.”

The FDA based its decision on clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness.

The data demonstrated an 89% reduction in the risk of COVID-19-related hospitalization or death from any cause in adults treated with PAXLOVID, compared to placebo, within three days of symptom onset (primary endpoint).

No deaths occurred in the treatment group compared to nine deaths in the placebo group by Day 28.

Similar results were seen in those treated within five days of symptom onset (secondary endpoint), with an 88% reduction in risk and no deaths observed in the treatment group.

Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity.

While PAXLOVID clinical trials did not include patients under the age of 18, the authorized adult dosing regimen is expected to result in comparable blood concentration levels of PAXLOVID in pediatric patients 12 years of age and older weighing at least 40 kg.

Additional Phase 2/3 clinical trials are ongoing in adults at standard risk (i.e., low risk of hospitalization or death) of progressing to severe illness, and in those who have been exposed to the virus through household contacts.

With PAXLOVID now authorized for emergency use, Pfizer stands ready to start delivery in the U.S. immediately.

In November 2021, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of PAXLOVID, with delivery fulfillment expected to be completed in 2022.

Regulatory Activity Outside of the U.S.
In addition to the U.S. FDA EUA, on December 16, 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued advice 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 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. 

Pfizer has submitted applications for regulatory approval or authorization to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow.

The company also plans to file a New Drug Application (NDA) with the FDA in 2022 for potential full regulatory approval.

Please see Full Emergency Use Authorization (EUA) Prescribing Information available at www.fda.gov and www.COVID19oralRx.com.

Our Commitment to Equitable Access
Pfizer is committed to working toward equitable access to PAXLOVID for all people, aiming to deliver safe and effective antiviral therapeutics as soon as possible and at an affordable price.

If authorized or approved, during the pandemic, Pfizer will offer its oral antiviral therapy through a tiered pricing approach based on the income level of each country to promote equity of access across the globe. High and upper-middle income countries will pay more than lower income countries.

Pfizer continues to invest to support the manufacturing and distribution of PAXLOVID, including exploring potential contract manufacturing options.

As a result of these efforts, Pfizer is raising its production projections from 80 million to 120 million courses of treatment by the end of 2022. 

The company has entered into agreements with multiple countries and has initiated bilateral outreach to approximately 100 countries around the world.

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral antiviral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population. “

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-receives-us-fda-emergency-use-authorization-novel

FDA Announces Outbreak Investigation of Listeria monocytogenes Found in Fresh Express Packaged Salad

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FDA Announces Outbreak Investigation of Listeria monocytogenes Found in Fresh Express Packaged Salad

December 21, 2021: “The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response“The FDA, along with the CDC and our state and local partners, is working to investigate a multistate outbreak of Listeria monocytogenes infections.

To date, a positive sample of Fresh Express Sweet Hearts salad mix has been reported to match the outbreak strain.

Fresh Express has voluntarily recalled products and consumers are advised not to eat, sell or serve any recalled products.

Our investigation is ongoing, and we will continue to communicate should additional products be implicated. 

“Ten people infected with the outbreak strain have been reported from eight states.

A sample of Fresh Express prepackaged romaine and sweet butter lettuce was collected by the Michigan Department of Agriculture and Rural Development as part of their routine sampling efforts.

The sample tested positive for Listeria monocytogenes and was a match to the outbreak strain. Given this, Fresh Express voluntarily ceased production at their Streamwood, Illinois, facility and initiated a recall of certain varieties of its branded and private label salads produced in that facility. 

“We will continue to work with our partners and with Fresh Express to determine the source of this outbreak.

We remain committed to transparency and providing updates as we learn more during our continuing traceback investigation.”

Additional Information:

The U.S. Food and Drug Administration, along with the U.S. Centers for Disease Control and Prevention and our state and local partners, is working to investigate a multistate outbreak of Listeria monocytogenes infections associated with the consumption of packaged salad. 

To date, this outbreak has been associated with 10 illnesses, 10 hospitalizations and one death spanning the following states: IL, MA, MI, NJ, NY, OH, PA and VA. Illnesses started on dates ranging from July 26, 2016, to Oct. 19, 2021.

Consumers who have symptoms of listeriosis infection should contact their health care provider. Most people with listeriosis include a fever, muscle aches, nausea, vomiting and diarrhea.

If the more severe form of listeriosis develops, symptoms may include headache, stiff neck, confusion, loss of balance and convulsions.

For the very young, the elderly and the immune-compromised, listeriosis can result in death.

Fresh Express voluntarily ceased production at their Streamwood, Illinois, facility and initiated a recall of certain varieties of its branded and private label salad products produced at the company’s Streamwood, Illinois, facility. The recall includes all Use-By Dates of fresh salad items with product codes Z324 through Z350.

Consumers, restaurants and retailers, should not eat, sell or serve recalled packaged salads. A full list of recalled products is available on the FDA’s website.

The FDA recommends that anyone who received recalled products use extra vigilance in cleaning and sanitizing any surfaces and containers that may have come in contact with these products to reduce the risk of cross-contamination.

Listeria can survive in refrigerated temperatures and can easily spread to other foods and surfaces.

This is an ongoing investigation, and additional information will be provided as it becomes available.

https://www.fda.gov/news-events/press-announcements/fda-brief-fda-announces-outbreak-investigation-listeria-monocytogenes-found-fresh-express-packaged

FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in Dogs

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FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in Dogs

December 21, 2021: ‘The U.S. FDA conditionally approved Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea in dogs.

This is the first treatment to be approved for this condition. 

“Diarrhea is a common side effect of chemotherapy in dogs, which can be so severe that cancer treatment must be halted.

Chemotherapy drugs often have potential side effects, but, unlike in human medicine where patients may be willing to tolerate some discomfort in exchange for a potential cure, the primary purpose of cancer treatment in dogs and other pets is to extend survival without sacrificing quality of life and comfort,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine.

“This new medication provides veterinarians and dog owners with another tool to help control the side effects of chemotherapy for dogs undergoing such treatment.”

Canalevia-CA1 is available only by prescription due to the professional veterinary expertise required to properly diagnosis the cause of diarrhea and monitor dogs receiving chemotherapy.

Canalevia-CA1 is a tablet that is given by mouth and can be prescribed for home treatment. 

The active ingredient in Canalevia-CA1 is crofelemer, which is approved for use in humans to treat non-infectious diarrhea in adults with HIV/AIDS who take anti-retroviral therapy.

In humans, crofelemer functions by inhibiting the secretion of chloride ions and water by intestinal epithelial cells, thereby normalizing the gastrointestinal tract. It is thought that the drug functions similarly in dogs. 

Canalevia-CA1 received conditional approval through the Minor Use/Minor Species pathway, which is an option for drugs intended for minor uses in major species (dogs, cats, horses, cattle, pigs, turkeys and chickens) or for minor species.

Canalevia-CA1 qualified for conditional approval because the FDA estimates that only about 1% of dogs in the U.S. receive a diagnosis of malignant neoplasia (cancer) per year, and not all dogs that receive treatment suffer from chemotherapy-induced diarrhea.

Therefore, the agency estimates the rate of occurrence of chemotherapy-induced diarrhea in dogs in the U.S. to be fewer than 70,000 dogs, which qualifies it as a minor use in a major species.

Conditional approval allows an animal drug sponsor to legally market its product after demonstrating that the drug is safe and manufactured in accordance with full approval standards, and that there is a reasonable expectation of the drug’s effectiveness.

The initial conditional approval is valid for one year with the potential for four annual renewals.

During this time, the animal drug sponsor must demonstrate active progress toward proving substantial evidence of effectiveness for full approval.

The animal drug sponsor has five years to obtain full approval after receiving conditional approval, or it will no longer be allowed to be marketed.

The reasonable expectation of effectiveness of Canalevia-CA1 was established in a study with 24 dogs (12 treated and 12 control). A dog was considered a treatment success if its diarrhea resolved and didn’t recur during the three-day study.

Resolution of diarrhea was defined as a fecal score of one (well-formed stool) or two (soft or very soft, moist stool that doesn’t have a clear shape).

On the third day, 9 out of 12 dogs (75%) in the treated group were treatment successes compared to 3 out of 12 dogs (25%) in the control group.

Additionally, diarrhea had resolved by 48 hours in 4 of the 12 dogs (33%) in the treated group compared to none of the dogs in the control group. 

The most common side effects across the laboratory studies and field studies were abnormal feces (soft, watery, mucoid, discolored feces), decreased appetite and activity and vomiting. 

Veterinarians should advise owners about the possible side effects before using the drug.

The FDA encourages dog owners to work with their veterinary team to report any adverse events or side effects potentially related to the use of any drug, including Canalevia-CA1.

The FDA granted conditional approval of Canalevia-CA1 to Jaguar Animal Health. “

https://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-oral-tablet-treat-chemotherapy-induced-diarrhea-dogs

Vaxzevria significantly boosted antibody levels against Omicron

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Vaxzevria significantly boosted antibody levels against Omicron

December 23, 2021: “AstraZeneca’s Vaxzevria (ChAdOx1-S [Recombinant]) significantly boosted levels of antibodies against the Omicron SARS-CoV-2 variant (B.1.1.529) following a third dose booster, according to data from a new laboratory study.

Neutralisation titres for Omicron were boosted following a third dose with Vaxzevria compared to titres after a second dose.

The levels seen after the third dose booster were higher than the neutralising antibodies found in individuals who had been previously infected with and recovered naturally from COVID-19 (Alpha, Beta, Delta variants and original strain).

Sera obtained from individuals one month after receiving the third dose booster vaccination neutralised the Omicron variant to levels that were broadly similar to those observed one month after the second dose against the Delta variant. 

Two doses of Vaxzevria have been associated with protection against the Delta variant in real world studies.2,3

The study analysed blood samples taken from individuals infected with COVID-19; those who had been vaccinated with a two-dose schedule and a third dose booster; and those who had reported previous infection from other COVID-19 variants of concern.

The study included samples from 41 individuals who had received three doses of Vaxzevria.

The study was performed independently by investigators at the University of Oxford and the findings were posted online on the bioRxiv pre print server.

Professor Sir John Bell, Regius Professor of Medicine, University of Oxford, UK and one of the study investigators, said: “It is very encouraging to see that current vaccines have the potential to protect against Omicron following a third dose booster.

These results support the use of third dose boosters as part of national vaccine strategies, especially to limit the spread of variants of concern, including Omicron.”

Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said: “Vaxzevria plays an important role in vaccination programmes around the world and these data give us confidence that the vaccine should be given as a third dose booster.

It is also important to look beyond antibodies to better understand how vaccines offer protection against Omicron.

As we better understand Omicron, we believe we will find that T-cell response provides durable protection against severe disease and hospitalisations.”

Data from another laboratory study support Vaxzevria’s effect against Omicron, with individuals vaccinated with two doses of Vaxzevria retaining neutralising activity against Omicron, although a decrease was seen compared to the original strain.

In other studies, Vaxzevria has been shown to generate a diverse and durable T-cell response to multiple variants resulting in a broader response than antibodies alone, which could contribute to protection against COVID-19.

AstraZeneca is collecting real world evidence evaluating the effectiveness against the Omicron variant with academic groups in the southern African region.

AstraZeneca is also analysing blood samples from participants in the Company’s Phase II/III trial to evaluate neutralising activity when given as a third dose booster against Omicron for both Vaxzevria and its investigational next generation COVID-19 vaccine, AZD2816.

Data from these studies are expected soon.

Currently available data against variants of concern, excluding Omicron, support the use of a third booster with Vaxzevria as part of a homologous or heterologous schedule.

A sub analysis from the COV001 and COV002 trials demonstrated that a third dose of Vaxzevria given at least six months after a second dose boosted antibody levels six-fold and maintained T cell response.

A third dose also resulted in higher neutralising activity against the Alpha, Beta, and Delta variants, compared with a two-dose regimen.

In the trial, the third dose of Vaxzevria was less reactogenic than the first dose.6

In addition, the COV-BOOST trial showed that a third dose booster of Vaxzevria induced significantly higher immune responses compared with controls against the Delta variant and original strain following a primary vaccine series of Vaxzevria or Pfizer BioNtech (BNT162b2).”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/vaxzevria-significantly-boosted-antibody-levels-against-omicron.html

Pfizer to provide UK with additional 2.5M treatment courses of Paxlovid

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Pfizer to provide UK with additional 2.5M treatment courses of Paxlovid

December 22, 2021: ” Pfizer Inc. announced an additional agreement with the United Kingdom (UK) government to supply an additional 2.5 million treatment courses of its investigational candidate PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), subject to local authorization.

This is in addition to the 250,000 treatment courses previously contracted by the UK Government, pending authorization and recommendation for use, bringing the full amount of treatment courses to 2.75 million.

“Final data from our Phase 2/3 trial in high-risk participants confirmed the overwhelming efficacy of PAXLOVID in reducing the risk of hospitalization by nearly 90% compared to placebo when treated within both three and five days of symptom onset and no deaths.

We are pleased that the UK government recognizes the importance of this potential treatment option,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“As we continue to combat the virus, we are in discussions with governments around the world to help ensure we get this potential treatment to patients as quickly as possible, subject to authorization or approval.”

In anticipation of the potential for regulatory authorization or approval, Pfizer initiated
manufacturing of PAXLOVID earlier this year and expects to produce up to 80 million courses of treatment by the end of 2022, with 30 million treatment courses available in the first half of the year. 

Our Commitment to Equitable Access 
Pfizer is committed to working toward equitable access to PAXLOVID for all people, aiming to deliver well-tolerated and effective antiviral therapeutics as soon as possible and at an affordable price.

If authorized or approved, during the pandemic, Pfizer will offer our oral antiviral therapy through a tiered pricing approach based on the income level of each country to promote equity of access across the globe.

High and upper-middle income countries will pay more than lower income countries. 
 
Pfizer continues to invest up to approximately $1 billion to support the manufacturing and distribution of PAXLOVID, including exploring potential contract manufacturing options.

It has entered into agreements with multiple countries and has initiated bilateral outreach to approximately 100 countries around the world.

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral antiviral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.  

About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) 
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, pending clinical success of the rest of the EPIC development program and subject to regulatory authorization, at first awareness of an exposure – potentially helping patients avoid severe illness (which can lead to hospitalization and death) or avoid disease development following contact with a household member who contracts COVID-19.

Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the SARS-CoV-2 3CL (or main) 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. 
 
Current variants of concern can be resistant to treatments that are focused on the spike protein expressed on the surface of the SARS-CoV-2 virus, due to the mutations in this region. PAXLOVID, however, works intracellularly on the protease of the SARS-CoV-2 virus by inhibiting viral replication.

Nirmatrelvir has shown consistent in vitro antiviral activity against the previously identified variants of concerns (i.e., alpha, beta, delta, gamma, lambda, and mu).

In addition, nirmatrelvir potently inhibited the main protease associated with Omicron in an in vitro biochemical assay.

This indicates nirmatrelvir’s potential to maintain robust antiviral activity against Omicron. Additional in vitro antiviral studies with this variant are underway. 
 
If authorized or approved, PAXLOVID will be administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days.

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-provide-united-kingdom-additional-25-million
 

FDA approves Xarelto™ to treat venous thromboembolism and to prevent children

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FDA approves Xarelto™ to treat venous thromboembolism and to prevent children

December 21, 2021: ‘The U.S.FDA has approved two pediatric indications for Xarelto™ (rivaroxaban): the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of VTE and VTE related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.

“The approval of two new indications for Xarelto in the US is an important step in helping to address the burden of venous thromboembolism in a vulnerable patient population.

It will provide doctors with body weight-based dosing options in pediatric patients,” said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division and Chief Medical Officer at Bayer.

“The Xarelto suspension for oral use will obviate the need for adjustments of adult dosage forms and substantially reduce the number of injections needed for anticoagulation treatment and blood sampling.”

Xarelto is the only Factor Xa anticoagulant FDA approved for primary prevention of clots in pediatric patients following the Fontan procedure and the only anticoagulant to offer a liquid formulation for flexible, body weight adjusted dosing options for pediatric patients.

Current guideline options are limited and recommend treating pediatric patients with or at risk for reoccurrence of blood clots with standard anticoagulation therapy which requires injections or dietary restrictions, and regular laboratory monitoring.

Earlier this year, Xarelto was approved in Canada, the EU including UK, Japan, Switzerland and in various Latin American countries for the treatment of VTE and prevention of VTE recurrence in children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment.

The approval is based on evidence from three robust and well-controlled studies of Xarelto in adults (EINSTEIN DVT, PE and EXTENSION) with additional data from two Phase III clinical trials of Xarelto in pediatric patients: EINSTEIN-Jr., which examined pediatric patients with diagnosed VTE, and UNIVERSE, which evaluated pediatric patients who are at risk of VTE after recently undergoing the Fontan procedure.

EINSTEIN-Jr. is the largest study completed to date evaluating the treatment of pediatric patients with VTE, and UNIVERSE is the first clinical trial to examine a non-vitamin K antagonist oral anticoagulant (NOAC) for the prevention of thromboembolism in congenital heart disease post-Fontan pediatric patients.

About the EINSTEIN-Jr. Study
The randomized, open-label phase III EINSTEIN-Jr. study included 500 children aged from birth to below 18 years with documented acute VTE who had started heparin therapy for at least 5 days.

Children were assigned, in a 2:1 ratio, to receive body weight-adjusted rivaroxaban (tablets or oral suspension) in a 20 mg-equivalent dose, or standard of care with (low molecular weight) heparin, fondaparinux or vitamin K antagonist therapy.

The main treatment period was 3 months, but in children younger than 2 years with catheter related VTE it was 1 month.

Repeat imaging was carried out at the end of the treatment period. Results were also interpreted in the context of previous studies evaluating rivaroxaban in adults with VTE.”

https://media.bayer.com/baynews/baynews.nsf/id/US-FDA-approves-Xarelto-to-treat-venous-thromboembolism-VTE-and-to-prevent-VTE-in-children?OpenDocument&sessionID=1640147257

FDA Grants Marketing Authorization for Inferior Vena Cava Filter Removal Device

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FDA Grants Marketing Authorization for Inferior Vena Cava Filter Removal Device

December 21, 2021: “The U.S.FDA authorized marketing of the first laser-based device for the removal of Inferior Vena Cava (IVC) filters.

The device is designed for patients who have an IVC filter, a small cage-like device inserted into the largest vein in the body to capture blood clots and prevent them from traveling to the lungs.

The new device, called the Philips CavaClear Laser Sheath, is intended for the removal of tissue to facilitate detachment of an IVC filter during retrieval when previous methods of removal have failed.

“To date, there have been limited options for the successful removal of chronically embedded IVC filters, as they can be difficult to retrieve due to potential complications associated with the complex procedure,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.

“Today’s action by the FDA will provide physicians with an important tool for the safe removal of IVC filters and potentially help reduce complications for patients.

It also demonstrates FDA’s commitment to leveraging real world evidence where appropriate to evaluate device safety and effectiveness.” 

IVC filters are commonly used to treat patients who are at risk for pulmonary embolism (a blood clot in the lungs) when treatment with blood thinners cannot be used or is ineffective.

While some IVC filters are left in place permanently, the FDA issued a safety communication in 2014External Link Disclaimer based on reports of adverse events associated with IVC filters and recommended that implanting physicians consider removing the filter as soon as blood clots are no longer a risk for the patient.  

During removal, the Philips CavaClear Laser Sheath device is designed to facilitate detachment of firmly adherent IVC filters from the IVC wall using ultraviolet laser energy to remove a small amount of the tissue.

The device is designed for use in conjunction with conventional snare devices to assist in IVC filter removal. 

The FDA assessed the safety and effectiveness of the device through a retrospective, real-world evidence clinical study.

The study, which evaluated laser-assisted IVC filter removal in 265 patients at seven clinical sites, demonstrated a procedural technical success rate of 96%.

The study had a 3% rate of significant device-related complications, including IVC injury causing extravasation (bleeding), hematoma formation (bleeding outside of the blood vessel), and filter breakage. 

Use of the Philips CavaClear Laser Sheath device is contraindicated when a blood clot is present within the filter or surrounding veins, when the IVC filter is not accessible, or when the filter is nonmetal.

The device may not be used in removal of Bird’s Nest IVC filters and VenaTech IVC filters.   

The Philips CavaClear Laser Sheath was granted a Breakthrough Device Designation for the removal of IVC filters.

The Breakthrough Devices Program is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions and that otherwise meet the statutory criteria for Breakthrough Device Designation. 

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.

The FDA granted the marketing authorization to Philips.”

https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-inferior-vena-cava-filter-removal-device

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