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WHO issues first emergency use validation for a Covid-19 vaccine

WHO issued first emergency use validation for a Covid-19 vaccine, since the outbreak of the pandemic.

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Covid-19: AstraZeneca vaccine gets huge boost, produces immune response in elderly, Vaccine, COVID-19: Russia to roll out vaccine in September ahead of the West 

The World Health Organization (WHO), on Thursday, issued its first emergency use validation for a Covid-19 vaccine, since the outbreak of the pandemic started about a year ago.

The United Nations Health agency listed the Comirnaty Covid-19 mRNA vaccine, produced by Pfizer/BioNTech, for emergency use, as it emphasized on its equitable distribution globally.

READ: COVID 19: Debt Service Suspension Initiative extended to June 2021 – World Bank

This disclosure is contained in a statement that was issued by WHO on Thursday, December 31, 2020, and can be seen on its website.

The statement says that WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.

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READ: European countries ban flights from UK as new Covid-19 strain spreads

What the WHO top official is saying

WHO Assistant Director-General for Access to Medicines and Health Products, Dr Mariangela Simao, said, “This is a very positive step towards ensuring global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere.

“WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come forward for review and assessment. It’s vitally important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.

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READ: FG suspends passports of 100 Nigerians for refusing post-arrival Covid-19 test

While reviewing the data on the Pfizer/BioNTech vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis, regulatory experts convened by WHO from around the world and WHO’s own teams found that the vaccine met the must-have criteria for safety and efficacy set out by WHO and that the benefits of using the vaccine to address COVID-19 offset potential risks.

Meanwhile, the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) will convene on January 5, 2021, to formulate vaccine-specific policies and recommendations for this product’s use in populations, drawing from the SAGE population prioritization recommendations for COVID-19 vaccines in general, issued in September 2020.

READ: Covid-19: Russia applies to WHO for emergency use tag for its vaccine

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The Comirnaty vaccine requires storage using an ultra-cold chain; it needs to be stored at -60°C to -90°C degrees. This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible. For that reason, WHO is working to support countries in assessing their delivery plans and preparing for use where possible.

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READ: FG warns of significant increase in Covid-19 cases in January 2021

What you should know

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It can be recalled that the Pfizer/BioNTech Covid-19 vaccine, which was certified 95% effective in the prevention of coronavirus disease in the final study, got approval for emergency use in the United States and the UK.

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies and has the objective of making medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality.

READ: Covid-19: Nigeria is well into a Second Wave

The assessment looks at the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

READ: Covid-19: Europe launches mass vaccination of doses to end the pandemic

As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine.

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Chike Olisah is a graduate of accountancy with over 15 years working experience in the financial service sector. He has worked in research and marketing departments of three top commercial banks. Chike is a senior member of the Nairametrics Editorial Team. You may contact him via his email- [email protected]

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Coronavirus

Only 68.8% of Nigerians believe Covid-19 is real – SBM Intel

The survey revealed that 68.8% of Nigerians believe Corona is real, 14.4% are not sure while 16.7% don’t believe it’s real.

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As the country and indeed, the rest of the world continues to be ravaged by the pandemic, only 68.8% of Nigerians believe Covid-19 is real. While 39.9% of Nigerians say they will take the vaccine, 63.3% are opposed to another lockdown.

These and more details were disclosed by SBM Intel, a geopolitical research and strategic communications consulting firm in its recent Covid-19 report titled, ” Covid in Nigeria: The Second Wave”.

“The age demographics of the correspondents for the survey were chosen across a broad age category., “The majority of the respondents were between 28-40 years (36.7%) followed by those between 18-27 years (24.0%), then 41-55 years (22.2%) which represents the active (working) population. 9.5% of the respondents were older than 55 years, and a smaller percentage, 7.7% were younger than 18 years,” the report revealed.

If Corona is real…

  • The survey revealed that 68.8% of Nigerians believe Corona is real, 14.4% are not sure while 16.7% don’t believe it’s real.
  • Ekiti, Enugu, Kogi, Nasarawa, and Sokoto states had less than 50% of their respondents stating that the virus is real. These states have relatively low official death rates, Ekiti (7), Enugu (21), Kogi (2), Nasarawa (13) and Sokoto (20) compared to states with high death rates as Lagos (250), the FCT (106) and Edo (117).

An interviewee said: “The virus is real, but does not believe that it is present in Nigeria because people are not dying and they are not observing most of the precautions.”

  • The report disclosed that most people of all age categories don’t deny the existence of a virus, however, people who are older than 55 years have the highest percentage of respondents who are unsure of the existence of coronavirus, citing reduced social interactions and smaller circles which keeps them away from contact with infected persons.

If people are taking the right steps to prevent the virus

Despite the fact that over 68% of the respondents believe that the virus is real, 59.5% of the respondents representing a majority of the respondents do not think that people are taking the right measures to prevent COVID-19.

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  • “More interestingly, in some public institutions like banks and eateries where private security personnel enforces compliance with mask-wearing and hand sanitizing, people tend to comply just because such enforcement serves as an entry ticket. Researchers observed that once many people got into such premises, they took off their masks and started to flout other precautionary measures.

Covid-19 vaccinations 

  • “Only 39.9% of the respondents said they will take the vaccine. An almost equal proportion of respondents (35.9 %) said they will not take the vaccine which the government announced is to arrive in the country at the end of January, and 24.1% are unsure of their position at the moment.
  • Reasons for not wanting to receive the vaccine include mistrust with the government and religious beliefs.
  • “Some respondents held that it is a religious war to contaminate the children of God with evil substances. Some believe that the vaccines are a tool to depopulate Nigeria, while others expressed concern about the effectiveness ratio and the side-effects that the vaccine might have,” SBM said.

In case of another lockdown

  • 63.3% of Nigerians are opposed to another lockdown. The report cited the number is much lower than the past report which revealed 90.24% were opposed to the idea of another lockdown.
  • 15.1% are on the fence on this issue and only 21.6% of the respondents would support another lockdown.
  • Opposition to lockdowns was linked to economic and security impacts witnessed during the previous lockdown as the economy contracted to lead to unemployment and increased hardship for Nigerians.

What you should know 

  • Nairametrics reported that the Federal Government said that Nigeria is not contemplating another lockdown and urged Nigerians to ignore social media posts rumouring of the possibility of another lockdown.
  • President Muhammadu Buhari already disclosed in October 2020 that the Nigerian economy is too fragile to go into another lockdown.
  • Professor Julius Ihonvbere, Chairman, House Committee on Basic Education & Services, said the Federal and States governments should not impose a lockdown, but rather focus on serious control measures to help prevent the spread of the coronavirus.

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Coronavirus

COVID-19: FG to acquire vaccines that need less cooling

The FG has stated that it is in talks with Russia and India to procure vaccines that are less dependent on cooling facilities.

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Covid-19: AstraZeneca vaccine gets huge boost, produces immune response in elderly, Vaccine, COVID-19: Russia to roll out vaccine in September ahead of the West 

The Nigerian Government says it doesn’t plan to over-invest in Covid-19 vaccines that require extra cold storage and that it will prioritize vaccines that don’t require much cooling.

This was disclosed by Faisal Shuaib, National Primary Health Care Development Agency Chief in a briefing with newsmen on Tuesday reported by Reuters.

READ: Africa to spend $9 billion on Covid-19 vaccine, access to supply is big problem

“Our plan now is not to over-invest on ultracold equipment for vaccines like that of Pfizer vaccines, but go for vaccines that need less cooling facilities.

“We are currently engaged in talks with Russia and India to get more vaccines,” he said.

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READ: COVID-19: FG to disburse N10 billion for local vaccine production

What you should know 

  • Nairametrics reported earlier this month that the Federal Government stated that the National Primary Health Care Development Agency (NPHCDA) with its partners, is working to fix healthcare value chain roadblocks that may affect the fair distribution of Covid-19 vaccines.
  • The FG also disclosed through the NPHCDA its initial distribution plan for vaccines with the highest share of vaccines going to Kano State 3,557; Lagos 3,131; Katsina 2,361; Kaduna 2,074; Bauchi 1,900; Oyo 1,848; Rivers 1,766; Jigawa 1,712; Niger 1,558; Ogun 1,473; Sokoto 1,468; Benue 1,423; Borno 1,416; Anambra 1,379; Zamfara 1,336; Delta 1,306.

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Coronavirus

Covid-19: Oxygen demand in Lagos State has risen 5 times – Sanwo-Olu

Governor Sanwo-Olu has lamented the rising second wave of the pandemic in Lagos as the demand for oxygen increases by 5 times.

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The Lagos State Governor, Babajide Sanwo-Olu has warned that the rising second wave of the pandemic in Lagos has seen the demand for oxygen rise 5 times from 70 six-litre cylinders per day to 350 six-litre cylinders at Yaba Mainland Hospital alone.

The Governor also urged that all malaria-like symptoms should henceforth be considered as COVID-19 virus infection unless and until proven not to be so.

This was disclosed in a statement released by the Lagos State Government on Tuesday.

READ: Covid-19: Nigeria needs serious controls not a second lockdown – House Committee on Education

“Over the last few weeks, the demands for oxygen has risen from 70 six-litre cylinders per day to 350 six-litre cylinders in our Yaba Mainland Hospital. This is projected to more than double to 750 six-cylinders, before the end of January 2021,” the Governor said.

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He added that the State Government has decentralized provision of oxygen and other services needed for Covid-19 patients, citing provision of oxygen kiosks.

“ln addition to providing oxygen at our isolation centres, the Lagos State Government has decentralized the availability of oxygen across the State through the provision of 10 oxygen and sampling kiosks. Oxygen therapy and other related services will be provided to patients that require them.

READ: NPHCDA to address infrastructural gaps in COVID-19 vaccine supply

“Five of these 10 oxygen centers have been commissioned while the remaining five will be ready for use within the next four weeks. It is our expectation that these sampling kiosks would be easily accessible to residents that require oxygen therapy at the level of LGAs as stabilization points prior to onward transmission to our Isolation centres, if required.

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“This strategy is to further increase the fighting chance of Lagos residents that have contracted the virus and require immediate oxygen therapy,” he stated.

READ: Nigerian government spends equivalent of 83% of revenue to service debt in 2020

The Governor said that Lagos is closely monitoring plans by the FG to acquire vaccines and said the State has also resumed discussion with potential manufacturers. He also said the State is building its own regulatory framework for vaccine distribution.

“We are closely monitoring ongoing action by the Federal Government to procure COVID-19 vaccines for use in Nigeria. We have also opened discussions with vaccine manufacturers so that when the vaccine comes eventually we can ensure that Lagosians are catered for.

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“In the meantime, we are developing a strategy that will articulate the criteria, guidelines and regulatory framework for providing and monitoring vaccinations in Lagos.

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“The Lagos State Government is actively partnering with the private sector in the management of the COVID-19 pandemic, in the areas of testing, oxygen deployment, as well as the clinical management of moderate to severe cases. These partnerships have helped enhance the State’s response to the ever-changing circumstances of the pandemic,” Sanwo-Olu added.

READ: Nigeria spends N29 trillion on recurrent (non-debt) expenditure in last 10 years

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What you should know 

  • The Lagos State Government earlier disclosed that its bed occupancy levels at its public and private COVID-19 care centres increased to 51 per cent.
  • The Federal Government also alerted Nigerians that hospitals across the country are running out of facilities to handle more serious cases of coronavirus infections as the virus is spreading fast with mild symptoms in some victims and severe illnesses and death in others.
  • Nairametrics recently reported that the Federal Government, through the Ministry of Finance, announced the sum of N10 billion for the production of vaccines in Nigeria, to fight the coronavirus.

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