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.
COVID-19 Update in Nigeria
On the 2nd of December 2020, 122 new confirmed cases and 1 death was recorded in Nigeria
The spread of novel Corona Virus Disease (COVID-19) in Nigeria continues to record significant increases as the latest statistics provided by the Nigeria Centre for Disease Control reveal Nigeria now has 67,960 confirmed cases.
On the 2nd of December 2020, 122 new confirmed cases and 1 death was recorded in Nigeria, having carried out a total daily test of 7,101 samples across the country.
To date, 67,960 cases have been confirmed, 63,839 cases have been discharged and 1,177 deaths have been recorded in 36 states and the Federal Capital Territory. A total of 779,708 tests have been carried out as of December 2nd, 2020 compared to 756,237 tests a day earlier.
COVID-19 Case Updates- 2nd December 2020,
- Total Number of Cases – 67,960
- Total Number Discharged – 63,839
- Total Deaths – 1,177
- Total Tests Carried out – 779,708
According to the NCDC, the 122 new cases were reported from 11 states- Kaduna (37) Lagos (29 ), Plateau (25), Ekiti (9), Rivers (5), Ogun (5), Edo (4) Kwara (4), Bayelsa (2), Bauchi (1), and Kano (1).
Meanwhile, the latest numbers bring Lagos state total confirmed cases to 23,439, followed by Abuja (6,868), Plateau (3,902), Oyo (3,728), Kaduna (3,173), Rivers (3,001), Edo (2,703), Ogun (2,233), Delta (1,824), Kano (1,798), Ondo (1,728), Enugu (1,332), Kwara (1,110), Ebonyi (1,055), Katsina (1,030), Osun (947), Gombe (938). Abia (926), Bauchi (774), and Borno (745).
Imo State has recorded 677 cases, Benue (496), Nasarawa (493), Bayelsa (456), Ekiti (374), Akwa Ibom (339), Jigawa (331), Niger (298), Anambra (285), Adamawa (261), Sokoto (166), Taraba (163), Yobe (100), Kebbi (93), Cross River (90), Zamfara (79), while Kogi state has recorded 5 cases only.
Lock Down and Curfew
In a move to combat the spread of the pandemic disease, President Muhammadu Buhari directed the cessation of all movements in Lagos and the FCT for an initial period of 14 days, which took effect from 11 pm on Monday, 30th March 2020.
The movement restriction, which was extended by another two weeks period, has been partially put on hold with some businesses commencing operations from May 4. On April 27th, 2020, Nigeria’s President, Muhammadu Buhari declared an overnight curfew from 8 pm to 6 am across the country, as part of new measures to contain the spread of the COVID-19. This comes along with the phased and gradual easing of lockdown measures in FCT, Lagos, and Ogun States, which took effect from Saturday, 2nd May 2020, at 9 am.
On Monday, 29th June 2020 the federal government extended the second phase of the eased lockdown by 4 weeks and approved interstate movement outside curfew hours with effect from July 1, 2020. Also, on Monday 27th July 2020, the federal government extended the second phase of eased lockdown by an additional one week.
On Thursday, 6th August 2020 the federal government through the secretary to the Government of the Federation (SGF) and Chairman of the Presidential Task Force (PTF) on COVID-19 announced the extension of the second phase of eased lockdown by another four (4) weeks.
OFFICIAL: UK Approves Covid-19 Vaccine made by Pfizer/BioNTech
The United Kingdom has approved Covid-19 Vaccine produced by Pfizer/BioNTech and will start distributing from next week.
The United Kingdom has approved Covid-19 Vaccine produced by Pfizer/BioNTech and will start distributing from next week. The approval by UK Regulatory authorities makes the country the first to approve the vaccine in the world.
The emergency authorization clears the way for the rollout of the vaccine which had been certified to be 95% effective in preventing illness in the final analysis of phase 3 trial, from early next week.
The vaccine is given in two shots (doses).
According to reports monitored by Nairametrics, the vaccine will be administered firstly to medical workers and home caregivers, frontline health workers, those aged 80 and above before being made available to the general public.
The vaccine was made by German company BioNTech in conjunction with US Pharmaceutical giant Pfizer and is said to be 95% effective in preventing the disease. This is after it was tested on over 43, 000 people in the mandatory phase 3 trials.
The US Food and Drug Administration is currently reviewing the vaccine and could also approve its usage later in the month.
What they are saying
The government in its statement said, “The government has today accepted the recommendation from the Independent Medicines and Healthcare Products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s COVID-19 vaccine for use.’’
A UK government spokesperson also said:
“The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination.”
“I’m confident now, with the news today, that from spring — from Easter onwards — things are going to be better. We’re going to have a summer next year that everybody can enjoy.” Matt Hancock, UK health secretary.
Matt Hancock revealed that this is going to be one of the biggest civilian projects in history as 50 hospitals are preparing to administer the vaccine with 800,000 doses ready to be delivered from Belgium.
Hancock said, “I’m obviously absolutely thrilled with the news, very proud that the UK is the first place in the world to have a clinically authorized vaccine.’’
The UK regulator said on Wednesday, that the Covid-19, met its strict standards of safety, quality and effectiveness.
The UK had earlier given hope that it was going to act swiftly in approving a vaccine and then put doctors across the country on standby for a possible rollout. This will also come as a relief to the British Prime Minister, Boris Johnson, who has been facing a series of criticisms over his handling of the pandemic that has killed almost 60,000 people in the UK.
The UK’s vaccine committee is expected to decide which priority groups will be given the shot first; care home residents, health and care staff, the elderly and people who are clinically extremely vulnerable will be first in line.
The United Kingdom is said to have ordered over 357 million doses from seven manufacturers.
What you should know:
Pfizer has earlier announced that the Covid-19 vaccine it is developing in collaboration with its German partner, BioNTech, was certified 95% effective in preventing illness, much higher than expected. The approval of the vaccine by UK regulator, ahead of US counterpart, who is set to meet on December 10, to decide on whether to recommend emergency use authorization, marks a historic moment in the fight against COVID-19.
The European Medicines Agency had disclosed that it could give emergency approval for the Pfizer vaccine by December 29.
China has already given emergency approval for 3 experimental vaccines and has immunized about 1 million people since July.
Explore Data on the Nairametrics Research Website
COVID-19: Nigeria, 4 others contribute 77.6% of cumulative confirmed cases in Sub-Saharan Africa
South Africa, Ethiopia, Kenya, Nigeria, and Ghana have contributed 77.6% of cumulative confirmed COVID-19 cases in Sub-Saharan Africa.
The latest COVID-19 daily update report as of November 28th, 2020 shows that there are cumulative confirmed cases of 1,411,393 in Sub-Saharan Africa.
Out of the growing number, South Africa, Ethiopia, Kenya, Nigeria, and Ghana top the list with a total of 1,095,410 confirmed cases, representing 77.6% whilst the other 41 member-countries of the sub-region contributed 22.4%.
According to the report, South Africa tops the list with a cumulative confirmed case of 785,153 (55.6%), followed by Ethiopia 109,247 (7.7%), Kenya 82,605 (5.9%), Nigeria 67,330 (4.8%), and Ghana 51,075 (3.6%).
What you should know
- There are 55 countries in Africa out of which 46 countries are from the sub-Saharan African region.
- There are cumulative confirmed cases of 2,137,871 and deaths of 51,248, CFR(Case fatality rate) of 2.4%.
- In Sub-Saharan Africa, there are cumulative confirmed cases of 1,411,393 and deaths of 31,342, CFR of 2.2%.
- The Sub-Saharan Africa cumulative confirmed cases and deaths represent 66% and 61.2% of entire Africa’s figure respectively.
- Chad with 6.1% topped the list on CFR, followed by Liberia with 5.2% and Sao Tome & Principe 4.8% with the least coming from Eritrea 0%, followed by Burundi 0.1%.
- 5 countries contributed to 84% of deaths in the region and they are South Africa, Ethiopia, Kenya, Nigeria, and Cameroon.
- South Africa tops the list of cumulative deaths with 21,439 (68%), followed by Ethiopia 1,701 (5.4%), Kenya 1,445 (4.67%), Nigeria 1,173 (3.7%), and Cameroon 462 (1.5%).
- The least in the cumulative confirmed case comes from Eritrea with 577 followed by Burundi 684 as well as in the least cumulative death of 0 for Eritrea and 1 for Burundi.