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Feb222021 by PharmaTimesNo Comments

Nigeria May Get COVID-19 Vaccines in 10 Days –Minister

NEWS

Minister of Health, Dr. Osagie Ehanire, said in Lagos on Saturday that Nigeria might get COVID-19 vaccines in the next 10 days. “We are told that by the end of this month, which is about 10 days from now, we shall get the vaccines,’’ the minister said. “We do not produce the vaccines. They are manufactured abroad in about four or five countries,’’ he told newsmen at the end of an inspection tour of the Lagos University Teaching Hospital, Idi-Araba, Ehanire explained that the United States of America, the United Kingdom, Russia and China that had succeeded in producing the vaccines were now giving licences to other countries to reproduce them. “South Africa has a licence to make the Johnson and Johnson COVID-19 vaccines, while Russia only recently gave India the li

Feb192021 by PharmaTimesNo Comments

Recall of Instanyl 100mcg Nasal Spray Solution, Batch Number 447055 by Takeda UK Limited

NEWS

The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) that Takeda UK Limited is recalling Instanyl 100mcg nasal spray solution batch Number 447055. The recall is due to the observation of cracked vials during inspection of the bulk vials and release testing of the finished products. So far, the company has not received any reports of damage for the marketed products. However, the batch is being recalled as a precautionary measure due to the low potential for breaking or cracking of the glass vial, which is contained within the plastic actuator casing and a potential risk of microbial contamination. Instanyl is indicated for the management of breakthrough p...

Feb192021 by PharmaTimesNo Comments

Apotex Corp Recalls Enoxaparin Sodium Injection USP due to Mislabelling of Syringe Barrel Measurement Markings

NEWS

The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from the US FDA that Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. Enoxaparin Sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), Treatment of Acute Deep Vein Thrombosis, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin and Treatment of Acute...

Feb192021 by PharmaTimesNo Comments

WHO Urges COVID-19 Vaccine Manufacturers to Uphold Pledges

NEWS

The World Health Organisation on Thursday urged COVID-19 vaccine manufacturers to make good on their commitments as the planet’s poorest countries await their first doses. WHO Director-General, Tedros Adhanom Ghebreyesus said the Covax facility – the global COVID-19 vaccine procurement and distribution effort ensuring poorer countries can access doses – was now ready to begin vaccine distribution. Around 336 million AstraZeneca-Oxford doses and 1.2 million Pfizer-BioNTech doses – the only two vaccines with WHO approval – are set to start being shipped out later this month through Covax. “At the beginning of the year, I issued a call to action to ensure that vaccination of health workers was underway in all countries within the first 100 days of the year,” Tedros told a news co

Feb182021 by PharmaTimesNo Comments

Pfizer/BioNTech Vaccine ‘Neutralises’ S. African COVID-19 Strain

NEWS

The COVID-19 vaccine developed by German firm, BioNTech, in partnership with Pfizer, has been found to neutralise the South African variant of coronavirus, but with considerably fewer antibodies. An in vitro study published in the New England Journal of Medicine found that the neutralisation rate for the more infectious strain was weaker by approximately two thirds. Researchers at the University of Texas Medical Branch said it was unclear what effect that would have on the efficacy of the vaccine, since other factors were also key to the body’s immune response, such as the production of so-called T-cells. “There is no clinical evidence to date that the South African variant virus escapes vaccine-elicited protection from COVID-19 in vaccinated people,” Pfizer and BioN

Feb182021 by PharmaTimesNo Comments

NAFDAC Approves Covid19 Vaccine

NEWS

NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC) NAFDAC VACCINE COMMITTEE REVIEW OF ASTRAZENECA/OXFORD COVID-19 (COVISHIELD) VACCINE (SERUM INSTITUTE OF INDIA) RECOMMENDATION FOR EMERGENCY USE AUTHORIZATION PRESS BRIEFING FEBRUARY 18, 2021 1 INTRODUCTION The use of AstraZeneca/Oxford COVID-19 vaccine, a recombinant ChAdOx1 adenoviral vector encoding the structural surface glycoprotein (Spike protein) antigen of the SARS-CoV-2 was given an approval for Emergency Use Listing by WHO on Monday, February 15, 2021. WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and

Feb182021 by PharmaTimesNo Comments

Air Pollution Caused 160,000 Deaths Last Year –Group

NEWS

Serious pollution caused around 160,000 premature deaths in the world’s five most populous cities last year, even as air quality improved in some places due to coronavirus lockdowns, an environmental group said on Thursday. The worst-affected was New Delhi, the most polluted capital on Earth, where around 54,000 deaths are estimated to have occurred due to hazardous PM2.5 airborne particles, according to a report from Greenpeace Southeast Asia. In Tokyo, the figure was 40,000 with the rest spread across Shanghai, Sao Paulo and Mexico City, according to the report, which looked at the impact of microscopic PM2.5 matter produced by burning fossil fuels. “When governments choose coal, oil and gas over clean energy, it’s our health that pays the price,” said Avinash Chan

Feb182021 by PharmaTimesNo Comments

COVID-19: UN Urges G20 to Prepare ‘Global Vaccination Plan’

NEWS

The UN Secretary-General, Antonio Guterres, on Wednesday proposed that the Group of 20 set up an emergency task force to prepare a ‘Global Vaccination Plan’ against COVID-19. He told an open debate of the Security Council on “ensuring the equitable access to COVID-19 vaccines in contexts affected by conflict and insecurity”. “We have come together to create the COVAX facility, the one global tool to procure and deliver vaccines for low- and middle-income countries. “COVAX requires to be fully funded. “But we must do even more; our efforts need to be comprehensive and well-coordinated everywhere,” said Guterres. “The world urgently needs a Global Vaccination Plan to bring together all those with the required power, scientific expertise as well as production and

Feb172021 by PharmaTimesNo Comments

COVAX Statement on WHO Emergency Use Listing for AstraZeneca/Oxford COVID-19 Vaccine

NEWS

The Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (Gavi) and the World Health Organization (WHO), as co-leads of the COVAX initiative for equitable global access to COVID-19 vaccines, alongside key delivery partner UNICEF, are pleased to welcome the news that two versions of the AstraZeneca/Oxford COVID-19 vaccine have been given WHO Emergency Use Listing (EUL). Yesterday’s announcement means that two versions of the AstraZeneca/Oxford vaccine, produced by AstraZeneca-SK Bioscience (AZ-SKBio) and the Serum Institute of India (AZ-SII), are now available for global rollout through the COVAX Facility. Building on the early information provided in the interim distribution forecast published on 3 February 2021, COVAX will now complete the pr

Feb162021 by PharmaTimesNo Comments

Another New Coronavirus Variant Seen in The UK

Coronavirus, NEWS

Scientists have identified another new variant of coronavirus in the UK with some potentially troubling mutations. B.1.525 appears similar to the South African variant which prompted door-to-door tests in areas where it has been found. Researchers from Edinburgh University have found 33 cases so far in samples dating back to December. It has been seen in other countries too, including Denmark, Nigeria and the US. UK experts are studying it to understand what risk it poses. It is too soon to say if it should be added to the UK's list of "variants of concern" and whether mass testing for it should happen. Prof Ravi Gupta, from the University of Cambridge, is one of the scientists advising the government

Feb162021 by PharmaTimesNo Comments

NAFDAC Receives Dossiers of Four COVID-19 Vaccines for Evaluation –Minister

NEWS

The Minister of Health, Dr. Osagie Ehanire, on Monday disclosed that the National Agency for Food and Drug Administration and Control has received the dossiers of four different COVID-19 vaccines for evaluation ahead of their usage in Nigeria. Ehanire disclosed this at the weekly press briefing of the Presidential Task Force on COVID-19 in Abuja. He said the results of some of the evaluations were almost ready. He said since all COVID-19 vaccines were carrying a certain amount of risk, any vaccine not approved by the Ministry of Health through its agencies would be used in Nigeria. The minister said, “The National Agency for Food and Drug Administration and Control has received dossiers for Sputnik V vaccine of Russia, Covishield or Astra Zeneca manufactured under

Feb162021 by PharmaTimesNo Comments

Nigeria Records 29 Cases of UK COVID-19 Variant, Says NCDC

NEWS

The Nigeria Centre for Disease Control says it has confirmed 29 cases of the B.1.1.7 COVID-19 UK variant in the country. Director-General of NCDC, Dr. Chikwe Ihekweazu, disclosed this at the Presidential Task Force on COVID-19 briefing on Monday in Abuja, noting that the new variant had spread across six states in Nigeria. “We have now confirmed a total of 29 cases of the B.1.1.7 variant, and this has been confirmed in Edo, Kwara, Lagos, Osun, Oyo and FCT,” Ihekweazu said. The News Agency of Nigeria reports that B.1.1.7 COVID-19 variant was first detected in the UK and have since spread to other parts of the world. The B.1.1.7 variant, which health experts described as highly infectious, had spread to more than 80 countries, according to the World Health Organisat

Feb122021 by PharmaTimesNo Comments

Africa’s COVID-19 Deaths Rose by 40% in One Month –WHO

NEWS

The World Health Organisation Regional Office for Africa in Brazzaville, Congo, says deaths from COVID-19 in Africa have surged by 40 percent in the last month, pushing Africa’s death toll towards 100,000 since the first reported case on the continent on 14 February, 2020. This comes as Africa battles new, more contagious COVID-19 variants and gears up for its largest-ever vaccination drive. Speaking during a virtual briefing on Wednesday, the WHO Regional Director for Africa, Dr. Matshidiso Moeti, said, “The increasing deaths from COVID-19 we are seeing are tragic, but are also disturbing warning signs that health workers and health systems in Africa are dangerously overstretched. This grim milestone must refocus everyone on stamping out the virus.” According to the

Feb112021 by PharmaTimesNo Comments

WHO Backs Oxford Vaccine ‘Even if Variants Present’

NEWS

The World Health Organization recommends using the vaccine developed by the University of Oxford and AstraZeneca even in countries tackling new variants of coronavirus. Some new forms of the virus appear to make vaccines less effective. The WHO also says the vaccine can be used in people aged over 65, which some countries have advised against. Spacing out the two doses, as is happening in the UK, makes the vaccine more effective, it advises. The Oxford vaccine is seen as the "vaccine for the world" as it is cheap, can be mass produced and is stored in a standard fridge. However, it has attracted controversy about its effectiveness against new variants, whether it should be used in the elderly and how far apa...

Feb112021 by PharmaTimesNo Comments

Covid-19: Kent Virus variant ‘on Course to Sweep World’

NEWS

The coronavirus variant first found in Kent could become the world's dominant strain, the head of the UK's genetic surveillance programme has predicted. Prof Sharon Peacock told the BBC's Newscast podcast the new variant has "swept the country" and "it's going to sweep the world, in all probability". She said her work sequencing variants of the virus could be required for at least 10 years. The Kent variant has already been detected in more than 50 countries. It was first detected in September 2020 in south-east England and its rapid spread over the following months was cited as the reason for the introduction of new lockdown rules across the UK in January. Prof Peacock, director of the Covid-19 Geno