March 2021 – PharmaTimes

Mar312021 by PharmaTimesNo Comments

T Cells Induced By COVID-19 Infection Respond to New virus Variants: U.S. Study

NEWS

A critical component of the immune system known as T cells that respond to fight infection from the original version of the novel coronavirus appear to also protect against three of the most concerning new virus variants, according to a U.S. laboratory study released on Tuesday. Several recent studies have shown that certain variants of the novel coronavirus can undermine immune protection from antibodies and vaccines. But antibodies - which block the coronavirus from attaching to human cells - may not tell the whole story, according to the study by researchers at the National Institute of Allergy and Infectious Diseases (NIAID). T cells appear to play an important additionally protective role. “Our data, as well as the results from other groups, shows that the T cell response to COVI

Mar312021 by PharmaTimesNo Comments

WHO Calls for Further Studies, Data on Origin of SARS-CoV-2 Virus, Reiterates That all Hypotheses Remain Open

NEWS

The report of the international team on their Wuhan field visit, from 14 January -10 February 2021, was published today as WHO Director-General Dr Tedros Adhanom Ghebreyesus called for further studies. The report stems from a Member State resolution adopted by consensus at the World Health Assembly in May 2020 and calling on WHO “to identify the zoonotic source of the virus and the route of introduction to the human population, including the possible role of intermediate hosts, including through efforts such as scientific and collaborative field missions.” In remarks to Member States today, Dr Tedros, who received the full report on the weekend, thanked the team for their tireless work. He said it advances our understanding in important ways, while raising questions tha

Mar302021 by PharmaTimesNo Comments

New COVID Strain Detected in Israel; Pfizer Vaccine Purchase Bid Delayed

NEWS

A new coronavirus strain has been identified in Israel, the Health Ministry said on Tuesday, and the Pfizer/BioNTech vaccine, used primarily in a swift nationwide inoculation drive, appeared to be effective against it. Separately, a bid by the Israeli government to secure 36 million more Pfizer/BioNTech doses for use as booster shots or for children once they are eligible hit a snag this week over political infighting. The cabinet had been set for Monday to approve the purchase, at around 3.5 billion shekels ($1.05 billion), but it was called off in a squabble between Prime Minister Benjamin Netanyahu and his defence minister, Benny Gantz, who heads a rival party, over judicial appointments. The health ministry, which has spent 2.6 billion shekels on vaccines, without disc...

Mar302021 by PharmaTimesNo Comments

GSK to Support Manufacture of Novavax’ Covid-19 Vaccine

NEWS

Novavax, a biotechnology company developing next-generation vaccines for serious infectious diseases, GSK and the UK Government Vaccines Taskforce announced that they have reached an agreement in principle to support manufacturing of up to 60 million doses of Novavax’ Covid-19 vaccine candidate (NVX-CoV2373) for use in the UK. GSK will provide ‘fill and finish’ manufacturing capacity at its Barnard Castle facility in the North East of England beginning as early as May 2021, with a rapid technology transfer between the two companies beginning immediately. GSK and Novavax will negotiate a final agreement to include additional terms and conditions. The UK Government has secured 60 million doses of the vaccine under an advance purchase agreement with Novavax. The protein an

Mar302021 by PharmaTimesNo Comments

COVID-19: Analysis of the Sensitivity of the UK (B.1.1.7) and South African (B.1.351) Variants to SARS-CoV-2 Neutralizing Antibodies

NEWS

The B.1.1.7 and B.1.351 variants of SARS-CoV-2 were first detected in the UK and South Africa respectively, and have since spread to many other countries. Scientists from the Institut Pasteur joined forces with Orléans Regional Hospital, Tours University Hospital, Créteil Intercommunal Hospital, Strasbourg University Hospital and Georges Pompidou European Hospital to study the sensitivity of these two variants to neutralizing antibodies present in the serum samples of people who have been vaccinated or previously infected with SARS-CoV-2. They compared this sensitivity with that of the reference virus (D614G), which was until recently the most widespread strain in France. The scientists demonstrated that the UK variant is neutralized to the same degree as D614G, whereas

Mar302021 by PharmaTimesNo Comments

Mediator drug: French Pharmaceutical Firm Fined Over Weight Loss Pill

NEWS

A French drug maker has been found guilty of aggravated deceit and involuntary manslaughter over a weight loss pill at the centre of a major health scandal. The drug Mediator was developed for use in overweight diabetics and was on the market for 33 years. It was eventually withdrawn in 2009 over concerns it could cause serious heart problems. Hundreds of people are believed to have died as a result of the drug. Around five million people were prescribed the medicine over the course of three decades, despite various warnings over its side effects. Thousands of plaintiffs were involved in the trial, which began in 2019. Drug maker Servier had denied any knowledge of Mediator's side effects but a court on Monday issued it wit...

Mar302021 by PharmaTimesNo Comments

Johnson & Johnson to Deliver 400m Single-Dose COVID-19 Vaccines to Africa

NEWS

Up to 400 million doses of Johnson & Johnson’s COVID-19 vaccine will be made available to African countries, the US pharmaceutical giant said Monday. The availability of the single-shot vaccine will be subject to national regulatory approvals in the African Union’s 55 member states, with the first shipments expected to arrive in the third quarter of 2021. “No one is safe until everyone is safe, and we have been committed to equitable, global access to new COVID-19 vaccines,” J&J’s CEO Alex Gorsky said in a statement. The company said Janssen Pharmaceutica, a J&J subsidiary, had entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to initially make available up to 220 million doses of its vaccine. AVAT can order an additional 180

Mar302021 by PharmaTimesNo Comments

Public Alert No: 0010/2021 – Alert on Unregistered and Fake Insulin Tea for Diabetics

NEWS

The National Agency for Food and Drug Administration and Control (NAFDAC) wishes to notify the public of the circulation of an unregistered and fake product called Insulin Tea. Insulin Tea claims to reduce blood sugar level and ‘delete’ sugar in the body. Please note that the NAFDAC Number shown on the packaging of this product (Nafdac Reg. No. 01-8662) is fake. Insulin Tea poses a danger to the health of the public. Members of the public are implored to contact the nearest NAFDAC office with any information concerning the distribution, sale and use of the fake Insulin Tea. Consumers are advised to report adverse events related to the use of regulated products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), pharmacovigilance@nafdac.gov.ng o

Mar292021 by PharmaTimesNo Comments

Public Alert No:007/2021 – Recall Of Phenylephrine Hydrochloride Injection Usp, 10mg/Ml By Sagent Pharmaceuticals Due To Potential Lack Of Sterility

NEWS

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by U.S Food and Drug Administration that Sagent Pharmaceuticals is recalling three lots (PHT8IB2 PHT9IB2 PHT1JB2) of PHENYLEPHRINE HYDROCHLORIDE INJECTION USP, 10mg/ml due to potentially loose crimped vial overseals. A non-integral crimped vial overseal may result in a non-sterile product. Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life-threatening. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. To date, Sagent has not received reports of any adverse events associated with this issue. Phenylephrine Hydrochloride Injection, USP is a...

Mar292021 by PharmaTimesNo Comments

Medical Product Alert N°2/2021: Falsified COVID-19 Vaccine BNT162b2

NEWS

This WHO Medical Product Alert refers to falsified COVID-19 Vaccine identified as “BNT162b2” detected in Mexico in February 2021 and recently confirmed as falsified to the WHO. The falsified product was supplied and administered to patients outside authorized vaccination programs. This falsified COVID-19 Vaccine may still be in circulation in the region and may continue to be offered to patients outside authorized vaccination programs. Laboratory analysis of the contents of the falsified products is pending and this Alert will be updated as soon as results are available. Genuine COVID-19 Vaccine BNT162b2 is indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus, in individuals 16 years of age and older. The use of genuine COVID-19 vaccin

Mar292021 by PharmaTimesNo Comments

Public Alert No:006/2021 – Formaldehyde In Hair Smoothing Products: What You Should Know

NEWS

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by U.S Food and Drug Administration of the short- and long-term effects of formaldehyde exposure in Hair smoothing products. Most hair smoothing or straightening products release formaldehyde gas, a known human carcinogen as classified by the International Agency for Research on cancer, into the air during hair straightening or smoothing process. When formaldehyde is released into the air and is present in the air at levels exceeding 0.1 ppm, it can cause serious irritation of the eyes, nose and lungs. It can also cause skin sensitivity or allergic dermatitis. Recommendations Don’t apply the hair products yourself at home. Go to a licensed hair professional in a salon. Hair pr

Mar292021 by PharmaTimesNo Comments

Public Alert No. 005/2021 – Malaysian Health Ministry Bans Some Cosmetic Products

NEWS

The National Agency for Food and Drug Administration and Control has received information that the National Pharmaceutical Regulatory Agency (NPRA) of the Malaysian Health Ministry has named some cosmetic products that have been found to contain prohibited substances, including unauthorized scheduled poisons in cosmetic products. The Products listed below are no longer allowed to be imported/ manufactured/ distributed and sold in Malaysia. The use of cosmetic products that are falsely mixed with chemicals can cause serious adverse effects to health. Product details The banned cosmetic products and the prohibited substances they contain are as follows: S/N Product name Detected Scheduled Poisons 1. Beauty Sleep Treatment Cream Hydroquinone and Tretinoi...

Mar292021 by PharmaTimesNo Comments

Public Alert No. 003/2021 – Recall of Hygiaflore Psyllium Bio Transit Capsule by Super Diet Laboratories

NEWS

The National Agency for Food and Drug Administration and Control has received information that the Directorate-General for Competition, Consumer Affairs and Fraud Control of France has warned the French public about the recall of Hygiaflore Psyllium Bio Transit Capsule, a plant based food supplement by Super Diet due to presence of Ethylene oxide. Ethylene oxide is carcinogenic in humans. Lymphoma and leukemia are most frequently reported to be associated with occupational exposure to ethylene oxide. Stomach and breast cancers may also be associated with ethylene oxide exposure. Details The details of the affected product are as follows; Product name: HYGIAFLORE PSYLLIUM BIO TRANSIT capsules Manufacturer SUPER DIET Laboratories Type of packaging P...

Mar262021 by PharmaTimesNo Comments

UN Reports ‘Hidden Epidemic’ of Drug Use Among Older People in Nigeria

NEWS

A United Nations reports states that in Nigeria, the non-medical use of tranquillisers was most prevalent among people aged 60–64. The report, released on Thursday by the International Narcotics Control Board, also reported considerable use of non-medical pharmaceutical opioids and cough syrup among the 45–64 age group in the country. Tranquilisers have a calming effect and eliminate both the physical and psychological effects of anxiety or fear. Drugs that fall into this general category are benzodiazepines [a class of psychoactive drugs] and sedatives like barbiturates and sleep aids. Subsequently, the UN-linked INCB has called for more action on what it termed the “hidden epidemic” of drug use among older people. The INCB is the independent and quasi-judicial

Mar262021 by PharmaTimesNo Comments

COVAX Updates Participants on Delivery Delays for Vaccines From Serum Institute of India (SII) and AstraZeneca

NEWS

Deliveries of COVID-19 vaccines produced by the Serum Institute of India (SII) to lower-income economies participating in the COVAX Facility will face delays during March and April as the Government of India battles a new wave of COVID-19 infections. COVAX and the Government of India remain in discussions to ensure some supplies are completed during March and April. According to the agreement between Gavi and Serum Institute of India (SII), which included funding to support an increase in manufacturing capacity, SII is contracted to provide COVAX with the SII-licensed and manufactured AstraZeneca (AZ)-Oxford vaccine (known as COVISHIELD) to 64 lower-income economies participating in the Gavi COVAX AMC (including India), alongside its commitments to the Government of India....