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Covid-19: US FDA grants full approval to remdesivir as first vaccine to treat coronavirus

Remdesivir has become the first drug to obtain formal clearance for treating the coronavirus disease.

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The US Food and Drug Administration (FDA) on Thursday granted full approval to Gilead Sciences Inc. for its antiviral drug, remdesivir, making it the first drug to obtain formal clearance for treating the coronavirus disease after conditional authorization was given in May.

The regulators had granted an emergency use authorization for remdesivir earlier this year, and since then, the drug has become a widely used therapy for hospitalized Covid-19 patients. It was also reportedly given to President Donald Trump this month, when he was diagnosed with the coronavirus disease.

This was disclosed in a statement by Gilead Sciences on Thursday.

In its statement, Gilead said, “Veklury is now the first and only approved Covid-19 treatment in the United States.’’ While the drug was in short supply initially, Gilead said that the medicine is now widely available in hospitals across the country as manufacturing capacity has rapidly expanded.

This is coming some days after the World Health Organization (WHO) study had discovered that the remdesivir anti-viral drug had little or no effect on Covid-19 patients’ length of stay in the hospital or chances of survival. The WHO said it failed to prevent deaths among patients.

However, Gilead has criticized the WHO study. In a letter posted on the company’s website, Chief Medical Officer Merdad Parsey said the findings didn’t negate other results.

The approval of remdesivir, sold under the brand name Veklury, will allow Gilead to market the drug and talk about its benefits to doctors, nurses, and patients. That could help solidify its position as a go-to medicine for Covid-19 patients, even as other drugs for the disease begin to reach the market.

Other treatments have received authorization for emergency use, although that approval can be revoked once the public health emergency caused by the coronavirus pandemic is over. Other medications like the steroid dexamethasone are also being used in the fight against Covid-19.

Shares of Gilead gained 4.1% in trading after the close of regular market hours on Thursday. According to 13 analysts surveyed by Bloomberg, it is estimated that remdesivir will have sales of $2.17 billion this year.

The company said in June that it would charge U.S. hospitals roughly $3,120 for most patients who need remdesivir.

The approval is based on a U.S. government-sponsored trial involving over 1,000 hospitalized coronavirus patients that found that those who received the drug recovered about five days faster than those who got a placebo.

The overall side-effect rate was similar to the placebo in the government study. The most common side effects are nausea and elevated liver enzymes, according to the product’s label.

What this means: This will be a very huge boost to the global search for a vaccine for the coronavirus pandemic which has negatively impacted on the global economy with over 1 million deaths. This also appears to be a boost for Donald Trump, who had sought the development of a Covid-19 vaccine before the US Presidential election.

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Coronavirus

Covid-19: FG announces 4 phases in the vaccination process against the pandemic

The FG has released phased processes in its vaccination programme against the Covid-19 pandemic.

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The Federal Government has announced the phased processes in its vaccination programme against the Covid-19 pandemic, which is expected to take off on March 5, 2021.

This follows the expected arrival on Tuesday, March 2, 2021, of the first batch of 3,924,000 Covid-19 vaccines under the COVAX initiative from Mumbai, India.

This was disclosed in a statement by the Presidential Task Force (PTF) on Covid-19 on Monday, March 1, 2021.

The PTF said that the vaccine deployment, which is expected to be done by the National Primary Health Care Development Agency (NPHCDA), with assistance from other sister agencies, has been divided into 4 phases.

The 4 phases with the expected activities and vaccination processes include:

1. Phase 1 Vaccination Process

  • All frontline health workers to be vaccinated
  • Vaccines to be deployed to states based on their level of preparedness
  • Cargo planes to be provided for the transport of the vaccines to states.

It should be noted that the 3,924,000 vaccine doses expected to arrive on Tuesday will cater for the initial rollout and Phase 1 Vaccination stage.

2. Phase 2 Vaccination Process (Vaccination of the elderly from 50 years and above)

  • Vaccination of 60 years and above to occur first (Group 1), then
  • Vaccination of 50-55 years (Group 2) to follow

It should be noted that Nigeria is expected to receive another batch of Covid-19 vaccines for this stage.

3. Phase 3 Vaccination Process

  • Vaccination of those between 18 and 49 years with co-morbidities (such as hypertension, diabetes, lung disease, other heart diseases, liver or renal disease, and so on)

4. Phase 4 Vaccination Process

  • Vaccination of the rest of the eligible population between ages 18 and 49 years.

What you should know

Nigeria is expecting the arrival of the first batch of 3,924,000 Oxford/AstraZeneca Covid-19 vaccine on Tuesday, March 2, with vaccination expected to commence on March 5 at National Hospital Abuja for frontline health workers.

The expected arrival of the vaccine is coming after Ghana and Cote’D’Ivoire announced the arrival of the Covid-19 vaccine under the COVAX initiative.

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Coronavirus

How to register for Covid-19 vaccination in Nigeria

The NPHCDA has announced guidelines to register for COVID-19 vaccinations.

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The National Primary Health Care Development Agency, NPHCDA, has released guidelines on registering for Covid-19 vaccination in Nigeria.

The guidelines were announced Monday morning in a social media post and they are as follows:

Step 1: Visit https://nphcda.gov.ng/

Step 2: Click on ” covid-19 vaccination e-registration”

  • In the Registration Form for COVID-19 Vaccination you are to fill in; your full names, phone number, email address, date of birth, sex, the type of National ID you have, a residential address which states, the LGA of residence, ward of residence and preferred vaccination site.
  • You are meant to also select your preferred vaccination date and time slot, which ends with a photo update.

After doing the above steps, you will receive a message saying:

“Registration Completed! …Your Vaccination ID is:

Your data is successfully received.

Thank you for taking time to fill the form, you will receive an SMS and email shortly containing your Vaccination No. and other instructions.”

What you should know 

  • The Federal Government confirmed that the first tranche of Covid-19 vaccines will arrive in Nigeria on Tuesday, March 2, 2021.
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FG launches strategy for introduction of Covid-19 vaccine

The FG has launched a strategy for the phased and equitable introduction of the Covid-19 vaccine across the country.

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The Federal Government has launched a strategy for the introduction of the Covid-19 vaccine in a phased and equitable manner across the country.

The strategy code-named, “T.E.A.C.H”, was initiated by the National Primary Health Care Development Agency (NPHCDA), in collaboration with the Federal Ministry of Health (FMOH).

According to a report by the News Agency of Nigeria (NAN), the Minister of Health, Dr Osagie Ehanire, during the inauguration said the launch of T.E.A.C.H and Electronic Management of Immunization Data (EMID) will ensure the smooth rollout of the Covid-19 vaccination campaign across the country.

What the Minister of Health is saying

Ehanire stated, “Our goal is to introduce COVID-19 vaccine in a phased and equitable manner, based on the advice of the WHO and the experience we observe other countries to have made, and ultimately vaccinating all eligible Nigerians within the next two years, to ensure herd immunity.

“We in Nigeria finally have the privilege of joining other countries to start the vaccination, which will prioritise, first those people most at risk of infection due to their exposure in the line of duty.

”Vaccination with safe and effective COVID-19 vaccines is a critical part of the country’s strategy to counter the COVID-19 pandemic and the stop transmission of the virus. No private hospital or organisation has experience in handling this type of vaccine than the NPHCDA,” he said.

The minister also said that vaccines that were not approved by the National Agency for Food and Drug Administration and Control (NAFDAC) would be determined as dangerous and would be seized by the Nigeria Customs Services.

The minister also noted that in less than 24 hours, the first batch of AstraZeneca vaccines would arrive the country from the COVAX Facility and would be deployed.

On his own part, the Director-General of Nigeria Centre for Disease Control (NCDC), Dr Chikwe Ihekweazu, said a lot of work had been done to reduce the casualty of Covid-19 in the country’s population.

Ihekweazu, who was represented by Head of Special Projects and Partnerships at NCDC, Dr Priscilla Ibekwe said that a sister agency, the NPHCDA, was prepared to lead the roll-out of COVID-19 vaccines in the country and NCDC would collaborate with them to ensure a successful campaign.

The Executive Director, NPHCDA, Dr Faisal Shuaib, in his introduction of the T.E.A.C.H Strategy, said it was an Indigenous approach to roll out the Covid-19 vaccine in the country.

Shuaib said that the Country has provided an e-registration link to enable Nigerians to register for the Covid-19 vaccines themselves, to obtain their pre-vaccination numbers and scheduled date

He said that the first phase of the roll-out of the Covid-19 vaccine in the country would target front-line health workers, Covid-19 rapid response teams, laboratory network, petrol station workers and strategic leaders.

According to him, How COVID-19 will be rolled out, Phase 1- healthcare workers, security agents, first responders, petrol station workers, laboratory workers, and strategic political leadership.

What you should know

  • It can be recalled that the Federal Government had announced that Nigeria would receive its first batch of 4 million AstraZeneca Covid-19 vaccine from the COVAX initiative on Tuesday, March 2, 2021.
  • The COVAX Facility which is co-led by Gavi, the Vaccine Alliance, the WHO and the Coalition for Epidemic Preparedness Innovations (CEPI), with UNICEF as a key implementing partner, is a global scheme to procure and equitably distribute vaccines for free, especially among poorer countries, as the world moves to stop the spread of the coronavirus pandemic.
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