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Coronavirus Update – U.S FDA Revokes Hydroxychloroquine Emergency Use Approval; 573 new cases recorded in Nigeria

Tuesday, 16 June 2020, 3:32 am
in News, Nigeria
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573 new cases of Covid-19 and 4 deaths were confirmed in Nigeria on Monday according to NCDC report.  The new cases were reported across 19 states and FCT. Rivers state recorded the second largest number of new cases after Lagos state.

As at 15 June, total of 16,658 cases have been confirmed in Nigeria, with 5,349 recoveries and 424 deaths. Total of 94,323 samples have been tested for Covid-19 in Nigeria since the beginning of the outbreak.

This number of tests is highly inadequate, in detecting those infected with virus in the country. Thus, there is high percentage of community spread in the country to as much as 74% of the confirmed cases according to NCDC.

On Monday, The Director-General of the Nigeria Center for Disease Control (NCDC), Dr. Chikwe Ihekweazu, during the Presidential Task Force on COVID-19 press briefing in Abuja, warned that there are more coronavirus cases in Nigeria than being reported.

Read more; There are more Covid-19 cases out there than we’ve found – NCDC

Details of the new cases are; Lagos-216, Rivers-103, Oyo-68, Edo-40, Kano-21, Gombe-20, FCT-17, Delta-13, Plateau-12, Bauchi-12, Niger-10, Kebbi-9, Ogun-8, Ondo-8, Abia-7, Nasarawa-5, Borno-1, Kwara-1, Benue-1, and Anambra-1.

In the U.S, Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate to be used to treat certain hospitalized patients with COVID-19. This was announced in a news release by the agency.

Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.

FDA granted the EUA on March 28, 2020 based on the science and data available at the time.

Recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population for which chloroquine and hydroxychloroquine were authorized for emergency use, demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery.

This outcome was consistent with other new data, including data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19. The totality of scientific evidence currently available indicate a lack of benefit.

Read also; Nigeria Used 99% of Revenue for Debt Servicing in Q1 2020

FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D said “the FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence.”

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate. This action was taken following a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation.

Chloroquine and hydroxychloroquine are both FDA-approved to treat or prevent malaria. Hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.

Previous reports on Hyroxychloroquine

Recall that Investogist reported that, the World Health Organization on 25 May suspended the clinical trial of Hydroxychloroquine over safety concerns, following a study published on The Lancet that linked the drug to high rate of dangerous side effects and high mortality rate on Covid-19 patients .

Investogist also reported on 6 June, that The Director General of The World Health Organization (WHO) Tedros Adhanom Ghebreyesus, has said that the clinical trial of Hydroxychloroquine will be resumed, following the retraction of the Lancet publication by the authors.

Investogist also reported on 6 June that the Lagos state Commissioner for Health, Akin Abayomi on Friday said that the state is going ahead with the clinical trial of Hydroxychloroquine for the treatment of Covid-19 patients in the state.

Investogist also reported on 19 May that President Trump told reporters at the White House, that he is taking hydroxychloroquine for over a week, even though he did not test positive for Covid-19.

President Trump has been a vocal advocate of the drug’s effectiveness, in the treatment of Covid-19. He called it a “game-changer”. The effectiveness of the drug is being tested in several countries.

Investogist also reported on 2 June, that the United States sent 2 million doses of Hydroxychloroquine to Brazil as the country struggles with Covid-19 outbreak. The two countries issued a joint statement, saying that they will work together on clinical trials to evaluate the effectiveness of the drug.

 British scientists halted the drug trial on 5 June, after it found that the anti-malarial hydroxychloroquine, was “useless” at treating COVID-19 patients.

“This is not a treatment for COVID-19. It doesn’t work,” Martin Landray, an Oxford University professor who is co-leading the RECOVERY trial, told reporters.

“This result should change medical practice worldwide. We can now stop using a drug that is useless.”

The use of Hydroxychloroquine was first reported in China, in report that said the drug was found have high efficacy in the treatment of Covid-19 patients.

In Lagos State, on Monday the lawmaker representing Lagos-East Senatorial District at the Senate, Adebayo Osinowo, was reported to have died of Covid-19 related complications.

Osinowo died in one of the isolation facilities of the Lagos State Government according to Punch.

The Federal Government has suspended Executive Jet Services, for flying Musician, Azeez Fashola aka Naira Marley, to Abuja to attend a concert according to the Minister of Aviation, Hadi Sirika.

During the Presidential Task Force briefing in Abuja on Monday, he said the flight was not approved for Naira Marley rather that it was for Justice Okogie, for official assignment.

Sirika said “the person on that flight conducted a concert. We approved a flight, certainly not for a musician. The flight was approved to convey Honourable Justice Adefope Okogie from Lagos to Abuja and then back to Lagos for an official assignment”

Covid-19 Vaccine – Moderna has outlined plans for phase 3 clinical trials for its Covid-19 vaccine candidate mRNA-1273, which will begin in July and is expected to include about 30,000 participants.

The primary aim of  the study is to establish the efficacy of the vaccine in preventing symptomatic Covid-19 disease and secondarily, the prevention of severe cases of Covid-19 which require hospitalization.

Moderna also said that it had enrolled 350 out of its total planned 600 participants for the phase 2 trial which is currently underway.

The company said that it is on track to deliver roughly 500 million doses of the vaccine per year, and potentially up to 1 billion doses annually, starting from 2021. Overall, the pharma industry is moving much faster than expected with Covid-19 vaccine development. The total development time for the average vaccine was close to 11 years.

In another development, Johnson & Johnson will begin human trials of its Covid-19 vaccine over the second half of July, well ahead of its previous timeline of September.

The National Association of Resident Doctors (NARD) has commenced an indefinite nationwide strike on Monday, June 15, 2020, after six hours of failed negotiations and expirations of a 14 days ultimatum.

Aliyu Sokomba, NARD President, made this known, while addressing a press conference in Abuja. He said that National Executive Council of the Union also resolved to exclude doctors managing COVID-19 at the various isolation and treatment centres in Nigeria from the industrial action.

“The union has decided to exempt its members working in various coronavirus (COVID-19) isolation and treatment centres across the country. This followed the virtual extra-ordinary National Executive Council meeting of the association held on Sunday,” Sokomba said.

The President of the Nigerian Medical Association, Prof. Innocent Ujah, has called on the Federal Government to start responding early to the demands of health workers and not wait until strike is declared before doing the needful.

“The government has to respond appropriately. The government should not wait until a strike is declared before responding to the demands of health workers. It is not very nice.

“There are so many promises that have been made by the government to health workers and they are yet to be fulfilled.

In Kenya, four staff members working in the office of Kenya’s President Uhuru Kenyatta have tested positive for coronavirus, a statement from the presidency says.

Four staff members working in the office of Kenya’s President Uhuru Kenyatta have tested positive for coronavirus, a statement from the presidency says.

Kenya has confirmed 3,727 cases of the virus with 1,286 recoveries and 104 deaths reported.

In China, Beijing ramped up emergency response measures on Sunday after a spike in new coronavirus cases deepened fears of an emerging new wave of infections.

The municipal health commission said in a Sunday morning notice that 36 new cases of Covid-19 were confirmed on Saturday, the most since authorities began publishing daily figures. Over 100 cases have been recorded in recent days.

Beijing has recorded a spike in new coronavirus cases since Thursday, when the capital confirmed its first new infections in nearly two months. Most of the cases are linked to a wholesale market in the southwestern district of Fengtai.

China has halted salmon import from Europe, after the virus were detected on the shopping board use for cutting salmon, because of fears they might be linked to a coronavirus.

Mike Ryan, head of the WHO’s emergencies program, stopped short of saying packaging needs to be tested systematically following the new infections.

“I think we need to look at what has happened in this case. I don’t believe it is the primary hypothesis. But it needs to be explored,” Ryan said in a briefing.

Globally, there are 8,014,554 confirmed cases of Covid-19 with 3,838,361 recoveries  and 436,306 deaths. Over 26% of the confirmed global cases and deaths were reported in the U.S according to John Hopkins Coronavirus Resource Centre.

Written by;

Ifunanya Ikueze

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