Category: Medical/Health Care

A cheap antidepressant reduced the need for hospitalization among high-risk adults with COVID-19 in a study that was looking for existing drugs that could be repurposed to treat coronavirus.

Researchers tested the pill used for depression and obsessive-compulsive disorder because it was known to reduce inflammation and looked promising in smaller studies.

They’ve shared the results with the U.S. National Institutes of Health, which publishes treatment guidelines, and they hope for a World Health Organization recommendation.

“If WHO recommends this, you will see it widely taken up,” said study co-author Dr. Edward Mills of McMaster University in Hamilton, Ontario, adding that many poor nations have the drug readily available. “We hope it will lead to a lot of lives saved.”

The pill, called fluvoxamine, would cost $4 for a course of COVID-19 treatment. By comparison, antibody IV treatments cost about $2,000 and Merck’s experimental antiviral pill for COVID-19 is about $700 per course. Some experts predict various treatments eventually will be used in combination to fight the coronavirus.

Researchers tested the antidepressant in nearly 1,500 Brazilians recently infected with coronavirus who were at risk of severe illness because of other health problems, such as diabetes. About half took the antidepressant at home for 10 days, the rest got dummy pills. They were tracked for four weeks to see who landed in the hospital or spent extended time in an emergency room when hospitals were full.

In the group that took the drug, 11% needed hospitalization or an extended ER stay, compared to 16% of those on dummy pills.

The results, published Wednesday in the journal Lancet Global Health, were so strong that independent experts monitoring the study recommended stopping it early because the results were clear.

Questions remain about the best dosing, whether lower risk patients might also benefit and whether the pill should be combined with other treatments.

The larger project looked at eight existing drugs to see if they could work against the pandemic virus. The project is still testing a hepatitis drug, but all the others — including metformin, hydroxychloroquine and ivermectin — haven’t panned out.

The cheap generic and Merck’s COVID-19 pill work in different ways and “may be complementary,” said Dr. Paul Sax of Brigham and Women’s Hospital and Harvard Medical School, who was not involved in the study. Earlier this month, Merck asked regulators in the U.S. and Europe to authorize its antiviral pill.

Source: Voice of America

The U.S. Food and Drug Administration’s independent advisory committee endorsed giving child-size emergency doses of the Pfizer-BioNTech COVID-19 vaccine to children ages 5-11.

While it is considered rare for younger children to become seriously ill or die from COVID-19, FDA vaccines chief Dr. Peter Marks told the panel Tuesday that 1.9 million children in the 5 to 11 age group have tested positive and 8,300 have been hospitalized in the United States. Of those hospitalized, one-third needed intensive care, and nearly 100 died.

With the approval of the vaccine for use in children, officials said they hoped it would help close a major gap in the U.S. vaccine campaign that had been worrying parents, educators and public health leaders.

Regulators said shots could begin as soon as next week.

Last week, the White House said it had already obtained enough vaccine for the 28 million children in the United States who would become eligible and established a network of pediatricians, pharmacies and other health care providers to quickly distribute the shots.

The FDA, which isn’t bound by the panel recommendation, will make its decision in the next few days.

Pending FDA approval, the Centers for Disease Control and Prevention’s independent advisory committee is expected to consider the proposal next week.

In a related development, U.S.-based pharmaceutical company Moderna said a clinical trial showed that a low dose of its COVID-19 vaccine was safe for children ages 6 to 11.

The company said it inoculated more than 4,700 children with its two-dose vaccine about 28 days apart, with each shot about half the strength given to adults. Preliminary results show the antibody levels in the children were at same level as those seen in young adults who received a full dose.

Moderna says the children suffered mild side effects such as fatigue, headache, fever and pain at the injection site. The number of test subjects was too small to detect any rare side effects such as myocarditis, an inflammation of the heart, which has been detected mostly among boys and young men who received either the Moderna or the Pfizer vaccine.

The study has not been published by any peer-reviewed journal, but Moderna says it will soon present its findings to the FDA and other global drug regulators.

Meanwhile, the Reuters news agency is reporting that the African Union will purchase up to 110 million doses of the Moderna vaccine. The AU will receive 15 million doses before the end of the year, with another 35 million doses arriving in the first quarter of 2022 and up to 60 million in the second quarter.

The purchase was facilitated by the White House, which is deferring delivery of 33 million doses it had purchased from Moderna to give the AU an opportunity to negotiate with the company.

According to the report, in an email, AU coronavirus envoy Strive Masiyiwa said the deal allowed the alliance to increase the number of vaccines available immediately. He said, “We urge other vaccine producing countries to follow the lead of the (U.S. government) and give us similar access to buy this and other vaccines.”

The CDC has extended the coronavirus health rules for cruise ships until January 15, 2022. The current regulations, which were first imposed in March 2020 and include a requirement for ships to sail with at least 95% of passengers and crew fully vaccinated, were set to expire November 1.

The CDC says when the current regulations expire in January, it will shift to a voluntary program for cruise ship operators to detect and control the spread of COVID-19 on their vessels.

Source: Voice of America

The White House on Friday urged all those eligible in the United States to get COVID-19 booster shots to do so, one day after U.S. health and drug regulatory agencies endorsed an expanded list of recommended shots.

On Thursday, the Food and Drug Administration (FDA) and, later, the Centers for Disease Control and Prevention (CDC) endorsed the list of vaccines eligible for a booster shot to include the Moderna and singe-dose Johnson & Johnson vaccines. Previously, only people who had received the Pfizer-BioNTech vaccine had been recommended for booster shots.

During a virtual briefing by the White House COVID-19 Response Team, CDC Director Rochelle Walensky clarified exactly who is eligible for a booster shot.

Those people who initially received Pfizer or Moderna vaccinations are eligible for a booster if they are 65 and older six months after their last vaccination, adult residents of long-term care facilities, people with underlying medical conditions, and people who live or work in high-risk settings.

Anyone who received a single dose of Johnson & Johnson vaccine, two or more months ago, are eligible for a booster shot.

Walensky said the FDA and CDC recommendations also allow people to choose any authorized COVID-19 vaccine for a booster, regardless of their original shot.

Walensky was asked if this expanded list of booster shots might require the CDC to update the definition of “fully vaccinated.” She said the CDC has not yet changed that definition but said it may need to in the future.

Currently people in the United States are considered fully vaccinated if they have had two doses of the Pfizer-BioNTech or Moderna vaccine, or one dose of the vaccine made by Johnson & Johnson.

Source: Voice of America

U.S. President Joe Biden’s top medical adviser on Sunday defended vaccination mandates to combat the coronavirus, dismissing objections from conservative Republican state governors that they infringe on people’s freedom to control their health care.

“When you are in a public health crisis, sometimes unusual situations require unusual actions,” Dr. Anthony Fauci told the “Fox News Sunday” show. “In this case, it’s things like mandating, be they masks or vaccinations.”

“They’re very important,” he said. “We’re not living in a vacuum as individuals. We’re living in a society and society needs to be protected. And you do that by not only protecting yourself, but by protecting the people around you by getting vaccinated.”

Biden has directed businesses across the United States with 100 employees or more to force their workers to get vaccinated or undergo frequent testing for the virus that causes the COVID-19 disease, although it will be weeks before his directives take full effect. In addition, Biden has ordered members of the country’s armed forces and civilian government workers to get inoculated on a quicker time frame under the threat of being fired if they do not comply.

Biden’s orders have drawn opposition, from some rank-and-file military service members who have refused the vaccinations and civilian government workers who have filed suit against the mandate.

In addition, several Republican state governors, chiefly Greg Abbott in Texas and Ron DeSantis in Florida, two possible 2024 Republican presidential foes of Biden, have assailed the mandates. Both are trying to block all mandates in their states even though some large businesses and municipal school districts have ignored the governors’ directives and imposed their own vaccination or face-mask requirements.

In banning mandates in his state, Abbott last week said Biden’s orders are “another instance of federal overreach” and what he characterized as the “bullying” of private businesses.

Fauci declined to criticize Abbott personally for the governor’s opposition to any governmental or private business vaccination mandate in Texas, the country’s second most populous state.

But Fauci said, “From a public health standpoint, that is really unfortunate, because we know how effective vaccines are in preventing not only illness for the individual, but for diminishing the dynamics of the infection in society.”

“The data are very, very clear,” Fauci said. “Look at the difference between people who get vaccinated and people who are unvaccinated, in cases, in hospitalizations and in deaths.”

The number of new U.S. coronavirus cases has fallen to about 84,000 a day, with about 1,500 deaths a day being recorded, but health officials say unvaccinated people represent the overwhelming share of the victims in both groups of people.

“The more people we get vaccinated, the less likelihood there is going to be another surge as we go into the winter,” Fauci said.

Fauci has come under increasing attacks from conservatives who claim their freedom to control their health care outweighs public concerns.

Asked why he has become a polarizing figure, Fauci responded, “People [who] have conspiracy theories, who deny reality that’s looking them straight in the eye, those are people that don’t particularly care for me. And that’s understandable… sometimes the truth becomes inconvenient for some people.”

Source: Voice of America

NAIROBI —

Medical aid groups are welcoming plans by U.S. drug maker Moderna to build a plant for manufacturing vaccines in Africa. The groups say the plant, the first from a company making a COVID-19 vaccine, will help in fighting vaccine inequality.

African countries are facing a shortfall of nearly 500 million COVID-19 vaccines according to the World Health Organization.

The shortage has left most countries unable to vaccinate even the most vulnerable 10 percent of their populations.

Last week, U.S. drug maker Moderna announced plans to build a plant on the African continent. Its statement is raising hope Africa will have a sufficient supply of COVID-19 vaccines in the future.

Medical aid groups say although the plan will boost Africa’s vaccine manufacturing capacity, the continent still needs an immediate solution to shortages. Dr. Githinji Gitahi is the chief executive officer at Amref Health Africa.

“As significant as it is because of the high financial commitment of 500 million dollars, there are several other factors to consider,” said Gitahi. “One, that factory will not be a solution to the current challenge of vaccine access in Africa. If the factory is going to be ready in 2-4 years Africa wants to vaccinate at least 70% of its population by the end of June next year. Therefore, Africa still demands the most important step in redistribution of doses earmarked for rich countries to come into Africa.”

Although Moderna has yet to say where it will build the factory, at least 10 countries, among them Kenya, Morocco, South Africa and Senegal, have expressed an interest in hosting the facility.

Dr. Willis Akhwale, the chairman of Kenya’s vaccination task force, says Moderna will need to look at the project as a partnership with the host country.

“If Moderna is coming to open, they should come with an open mind that they are bringing technological transfer, not just setting up a factory,” said Akhwale. “Therefore, they need to transfer that technology to the host country. The other thing is capacity building of the local people beyond just the COVID-19 vaccine towards the whole human vaccine manufacturing.”

The Africa Centers for Disease Control and Prevention welcomes the idea of manufacturing the COVID-19 vaccine on the continent.

Dr. Bernhards Ogutu, chief research officer at the center’s office in Kenya, says although the process is likely to take a long time, it’s a promising sign for making health care more available in Africa.

“If we really want health care affordable and accessible to all, then we must start doing a lot of production of health commodities in the region,” he said.

By September, an estimated 5.2 billion COVID vaccine doses had been administered globally but only 2 percent of those were in Africa. African medical groups say they hope that the manufacturing of such vaccines on the continent will prevent such unequal distribution in the future.

Source: Voice of America

WASHINGTON —

The United States is sending more than 3.5 million doses of the two-shot Pfizer vaccine to Nigeria, Africa’s most populous nation, a White House official told VOA on Tuesday.

“We are sharing these doses not to secure favors or extract concessions,” the official said. “Our vaccines do not come with strings attached. We are doing this with the singular objective of saving lives.”

The 3,577,860 doses, which the White House said began shipping to Nigeria on Tuesday, follows a July donation of 4 million doses of the two-shot Moderna vaccine. The donation was processed through COVAX, the global vaccine-sharing initiative.

Nigeria has reported at least 2,747 deaths from the virus and some 208,000 confirmed cases, according to the World Health Organization. However, medical officials in Africa and overseas have expressed concern that the African continent’s true COVID-19 situation has been underdiagnosed and underreported.

On the continent, South Africa remains at the epicenter, with at least 88,317 deaths counted by WHO, and more than 2.9 million confirmed cases of COVID-19, the disease caused by the highly contagious coronavirus.

With more than 206 million people, Nigeria is a lower middle-income country, according to World Bank data. Nigeria has also accepted donations of vaccines from Russia, plus donations of diagnostic and treatment equipment, and test kits from China and South Korea, its Ministry of Health said.

As of this month, just over 7.2 million vaccine doses have been administered, according to WHO. That’s a far cry from the goal shared by Nigerian authorities to vaccinate 40% of its population — about 80 million people — by the end of 2021.

The nation appears to be emerging from a third viral wave, with a height of about 5,000 daily reported cases. The second wave, the nation’s worst, peaked in January, with nearly 12,000 new cases reported in one day, according to WHO data.

In September, U.S. President Joe Biden announced the U.S. would donate 500 million additional doses of the Pfizer vaccine to low-income and lower-middle-income countries. In all, the United States has now pledged 1.1 billion doses.

But aid groups say this is not enough, coming from the world’s wealthiest nation.

“Despite its claim to be a global leader on COVID-19, the U.S. is hoarding nearly 500 million excess COVID-19 vaccine doses — more than any other country,” said Dr. Carrie Teicher, director of programs at Doctors Without Borders’ U.S. branch. “It’s reckless and dangerous for the U.S. and other high-income countries to be sitting on excessive stocks of COVID-19 vaccines while others — including in many places where MSF (Doctors Without Borders) is battling surges of COVID-19 — are desperate to provide their most vulnerable people with even their first dose.”

U.S. officials have been criticized for urging booster shots for vulnerable Americans while vaccination rates are low in the developing world. The White House casts the controversy over booster shots as a false choice, claiming the U.S. can help vaccinate the world while also protecting Americans.

According to projections by the Oxford University COVID-19 database Our World in Data, only one nation in sub-Saharan Africa — the tiny enclave nation of Lesotho — is on track to meet the target of inoculating 40% of its population with at least one dose of the vaccine by the end of 2021.

Source: Voice of America

The World Health Organization is recommending that people with weakened immune systems be given a booster shot of the COVID-19 vaccine.

A panel of WHO vaccine advisers said the additional dose would help immunocompromised people because that population is less likely to respond to a standard vaccination, and they are at high risk of severe COVID-19 disease.

The panel, called the Strategic Advisory Group of Experts on Immunization (SAGE), also recommended booster shots for people over age 60 who have received inoculations made by Chinese vaccine makers Sinopharm and Sinovac. It cited evidence in studies in Latin America that those vaccines do not perform as well over time.

The panel did not recommend an additional booster dose for the population at large and said it would review the issue of widespread booster use on November 11.

WHO has called for a moratorium on booster doses for the general population until the end of the year to allow more people around the world to receive a first vaccination.

New COVID pill, drug

In other developments Monday, drugmaker Merck has asked U.S. regulators to authorize its pill for treating mild to moderate COVID-19, which if approved would be the first oral medication for the disease.

Merck said its antiviral pill, called molnupiravir, lowered the rate of hospitalization and death by 50% in a trial of patients who had mild to moderate COVID-19 illness along with at least one risk factor for the disease.

Merck and its partner Ridgeback Biotherapeutic have asked the U.S. Food and Drug Administration to grant emergency use of the pill. All previous FDA-approved treatments require an injection or IV.

Drugmaker AstraZeneca, which developed one of the first COVID-19 vaccines, said Monday it is seeing promising results with a COVID-19 drug it is developing to combat the coronavirus.

Known as AZD7442, the drug reduced severe COVID-19 or death in non-hospitalized patients by 50%, according to AstraZeneca.

“An early intervention with our antibody can give a significant reduction in progression to severe disease with continued protection for more than six months,” said Mene Pangalos, executive vice president at AstraZeneca’s biopharmaceuticals R&D.

Also Monday, Swiss drugmaker Roche said it has applied to market its antibody cocktail for COVID-19 in the European Union.

The treatment co-developed with U.S. biotech firm Regeneron is a combination of monoclonal antibodies that is intended to prevent patients from getting a severe form of the disease. Called Ronapreve, the treatment was given to former U.S. President Donald Trump when he was battling COVID-19.

In New Zealand

In New Zealand, the government announced Monday that it would require teachers and health care workers to be fully vaccinated against the coronavirus by December 1.

Ninety-five new COVID-19 cases were reported in New Zealand this weekend, and an additional 35 were reported Monday, as the country is attempting to reopen.

Maori politicians say New Zealand could be guilty of committing “modern genocide” if it goes forward with plans to reopen the country. They are warning that the country’s Indigenous people represent more than half of the daily cases.

“At every stage of this pandemic, the government has ignored the advice of our Maori experts. They have left us out to dry,” Debbie Ngarewa-Packer, co-leader of the Maori Party, said Monday.

According to Johns Hopkins University’s data, New Zealand has 4,660 infections and 28 deaths from COVID-19 since the pandemic began.

Worldwide, the Johns Hopkins Coronavirus Resource Center has recorded almost 238 million global COVID-19 infections and nearly 4.9 million deaths. The center said Monday that nearly 6.5 billion vaccines have been administered worldwide.

Source: Voice of America

A report in The New York Times says that the manufacturers of the Moderna coronavirus vaccine which “appears to be the world’s best defense against COVID-19, has been supplying its shots almost exclusively to wealthy nations, keeping poorer countries waiting and earning billions in profit.”

The newspaper said their report is based on information from Airfinity, a data firm that tracks vaccine shipments.

According to the Times account, Moderna has shipped approximately a million shots of its vaccines to poor countries. In comparison, Pfizer has shipped 8.4 million shots and Johnson and Johnson has delivered about 25 million doses to low-income countries.

In addition, the Times said government officials in some middle-income countries have reported that their countries have had to pay more for Moderna’s shots than the U.S. and the European Union.

Protests in Rome

Meanwhile, thousands of protesters took the streets of Rome Saturday to protest Italy’s new “Green Pass” vaccine certification that becomes mandatory for public and private workplaces, beginning October 15.

Workers and employees will be fined if they do not comply with the certification requirements. Government workers face suspension, if they come to work five times without the pass that documents that the holder has been inoculated with at least one COVID vaccine or recovered from the coronavirus in the last six months or has tested negative in the last 48 hours.

The pass is already a requirement for many indoor venues, including restaurants, museums and theaters. It is also needed for long-distance train and bus rides and domestic flights.

The chief of Britain’s Health Security Agency says the U.K. is facing an “uncertain” winter with the circulation of the flu and the coronavirus which causes the COVID infection.

“We are likely to see flu, for the first time in any real numbers, co-circulating with COVID,” Dr. Jenny Harries said. “Early evidence suggests that you are twice as likely to die from having two together, than just having COVID alone.”

Texas politician has COVID

In the U.S., a politician who has not been vaccinated has announced that he has COVID and is being treated with monoclonal antibody injections. Allen West, a candidate for the Republican nomination for the governor of Texas, said on his Twitter account that while he was not inoculated with a COVID vaccine, his wife was, but she has also contracted COVID.

The Johns Hopkins Coronavirus Resource Center reported early Sunday that there are more than 237 million global coronavirus infections and nearly 5 million global deaths. The center said 6.4 billion vaccines have been administered.

Source: Voice of America