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.
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: Coronavirus in Italy since September 2019 – Researchers
A new study suggests that the Coronavirus may have spread from China to other parts of the world earlier than previously thought.
A team of researchers at Italy’s National Cancer Institute (INT) revealed that the coronavirus may have been in Italy long before the World Health Organization announced the virus in December 2019.
This was disclosed in a Reuters report on Sunday evening. Italy officially reported its first case in the Lombardy region on the 21st of February.
Italian researchers disclosed that 11.6% in a lung cancer screening trial between September 2019- March 2020 already had covid-19 antibodies before February.
The Institute said Italy’s Lombardy region had reported higher than normal cases of flu and pneumonia in the 4th quarter of 2019, which are symptoms of the virus and a sign that the virus may have been in Europe before the WHO announced the news of the disease to the world.
“A further specific SARS-CoV-2 antibodies test was carried out by the University of Siena for the same research titled “Unexpected detection of SARS-CoV-2 antibodies in the pre-pandemic period in Italy.
“It showed that four cases dated back to the first week of October were also positive for antibodies neutralizing the virus, meaning they had got infected in September,” Giovanni Apolone, a co-author of the study told Reuters.
Researchers disclosed that trialists had developed no symptoms and also had antibodies able to kill the virus,
“It means that the new coronavirus can circulate among the population for long and with a low rate of lethality not because it is disappearing but only to surge again,” Apolone added.
Covid-19: Nigeria to seek $750 million from World Bank- Finance Minister
Loan is to help combat the effects of the pandemic on Nigeria’s economy.
The Minister of Finance, Zainab Ahmed disclosed that Nigeria is seeking a $750 million loan from the World Bank to help combat the effects of the pandemic on Nigeria’s economy.
This was reported by Channels TV after the Minister attended the inauguration of the Federal Steering Committees of the Nigeria COVID-19 Action Recovery and Economic Stimulus (N-CARES) program in Abuja on Friday.
What you should know
It was reported in August that the World Bank approved the sum of $114 million to assist Nigeria in its fight against the coronavirus pandemic.
According to a statement, the funds came in the form of a $100 million credit facility from the International Development Association (IDA) and $14 million grant from the Pandemic Emergency Financing Facility.
The World Bank, in its report for October 2020, titled “Charting the road to recovery,” warned Nigeria and other Africans not to relax despite recording lower cases and mortality rates compared to other regions of the world.
The Minister warned on Friday that Nigeria must develop plans to lift herself from the economic effects of the pandemic or face consequences.
“As part of windows of opportunity to mitigate the effect of Covid-19, the Federal Government is in the process of accessing a World Bank loan of 750 million dollars on behalf of the states to stimulate the local economy and support vulnerable household’s consumption,” she said.
“The consequences will be too high if we ignore the root cause of rising civil unrest in our country. We must, therefore, fashion out ways of ensuring that post-Covid-19 is not injurious to the Nigerian people and the economy.”
She added that members of the newly inaugurated committee were selected because the MDAs have an important role in lifting the economy back to prosperity, as Nigeria’s population is too large to remain under poverty.
“Members of the Federal Steering and Technical Committees because of the important role MDAs play in the recovery of the Nigerian economy as well as the fulfillment of lifting 100 million people out of poverty.
“The inauguration of the committees is expedient given the nature of this emergency intervention; Nigeria as the biggest economy in Africa cannot afford to remain in recession; the survival of over 200 million population is germane to all we do and we must address the concerns of the majority of our populace,” she said.
The World Bank announced plans in September for a $12 billion coronavirus financing initiative that will help poor and developing countries purchase enough Covid-19 vaccine doses to treat up to 2 billion people as soon as they become available in the coming months.
Liverpool Star, Mohamed Salah tests positive for Coronavirus
Liverpool forward, Mohamed Salah has tested positive for the novel Covid-19.
Liverpool and Egypt star player, Mohammed Salah has tested positive for COVID-19.
This was announced today by the Egyptian Football Association (EFA) confirmed today after all the players tested for the virus as is required, but only Salah’s results came back positive.
The EFA said: “The medical swab conducted on the mission of our first national football team showed that our international player, Mohamed Salah, the star of Liverpool, was infected with the Coronavirus after his test came positive.”
However, the EFA said there were no symptoms of the virus on the Liverpool star, “although he does not suffer from any symptom”. It might be a false positive, who knows? But the EFA also said more checks would be carried out on the Egyptian Star in the coming hours to confirm his status.
He’s now in isolation until further checks are carried out to confirm his virus status, the EFA said.
This is bad news for Liverpool because it adds to their long lists of injured players with the likes of Van Dijk, Joe Gomez, Trent Arnold on the sidelines.
During the last international break, Cristiano Ronaldo also contacted the virus and was unavailable for selection for more than 14 days.