NAIROBI, Kenya (AP) Burundis government now says it will accept COVID-19 vaccines, becoming one of the last countries in the world to embrace them. But the health ministry says it will not take responsibility for any side effects they might cause.
Health Minister Thaddee Ndikumana on Wednesday said the vaccines will arrive with the support of the World Bank. It was not immediately clear how many doses the East African country will receive or when.
The vaccine will be given to those who need it, the health minister said. The government will store the doses but will not take responsibility for any side effects, he added.
Burundis announcement came the same day that neighboring Tanzania launched its vaccination campaign, retreating from former President John Magufulis denial of the pandemic. He died in March and the presidency went to his deputy Samia Suluhu Hassan, who has since reversed course on COVID-19 in one of Africas most populous countries.
Burundis late President Pierre Nkurunziza, who died last year, also was criticized for taking the pandemic lightly. The administration of his successor, President Evariste Ndayishimiye, earlier this year said the country of more than 11 million people didnt yet need COVID-19 vaccines.
Burundi continues to carry out mass screenings for the virus, and the health minister noted the more infectious variants now spreading. If we do not change our behavior, we risk finding ourselves in the coming months at the starting point situation, he said.
Burundi has had more than 6,700 confirmed infections, according to the Africa Centers for Disease Control and Prevention.
Burundis decision leaves Eritrea, one of the worlds most closed-off nations, as the only African country that hasnt accepted the vaccines. Eritreas government has reported more than 6,500 confirmed cases.
The director of the Africa CDC, John Nkengasong, told reporters on Thursday he was not sure why Eritrea is not taking vaccines but we continue to engage them....We leave no country behind.
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
July 29 (Reuters) - The U.S. health regulator expanded the emergency use authorization for Eli Lilly's (LLY.N) COVID-19 drug baricitinib, saying it could now be used without taking Gilead's (GILD.O) drug remdesivir along with it, Lilly said on Thursday.
In November, the U.S. Food and Drug Administration (FDA) approved Lilly and Incyte's (INCY.O) arthritis drug, baricitinib, in combination with remdesivir, to treat COVID-19 patients.
"Based on the increasing body of evidence, we are confident in the potential of baricitinib as an important treatment for the hospitalized COVID-19 patient population requiring supplemental oxygen," Lilly said on Thursday.
FDA's expanded use for baricitinib was based on results from a trial done by the company in April.
The trial did not meet the main goal of preventing progression to ventilator use in hospitalized COVID-19 patients. However, the study showed baricitinib-treated patients were less likely than those receiving standard of care to progress to ventilator use or death.
The study enrolled 1,525 hospitalized COVID-19 patients who received either baricitinib or a placebo, along with the standard of care, which included corticosteroids and remdesivir.
Reporting by Dania Nadeem in Bengaluru; Editing by Shounak Dasgupta
Our Standards: The Thomson Reuters Trust Principles.
Gov. Phil Murphy said again Monday that vaccines against COVID-19 are 99.9% effective against getting the virus and 99.99% effective against dying from it. But the most recent data available shows a significant uptick in breakthrough cases and deaths since the delta variant became the dominant strain in New Jersey.
An NJ Spotlight News analysis of data from the state Department of Health for the most recent two-week period June 29 through July 12 found that the number of COVID-19 cases among fully vaccinated people increased by more than 16%. The number of hospitalizations jumped by two-thirds and the number of deaths rose by 55%, that analysis found.
The spike in infections among those fully vaccinated bears out fears of health experts that the much more highly transmissible delta variant would lead to increased cases, hospitalizations and deaths. About three-quarters of the viruses sequenced in New Jersey over the last four weeks were the delta variant, according to the health departments COVID-19 dashboard. New Jersey lifted its mask mandate on May 28, but Murphy and state Commissioner of Heath Judith Persichilli on Wednesday urged all residents, including those fully vaccinated, to mask up again in certain circumstances. That followed similar guidance issued by the Centers for Disease Control and Prevention on Tuesday.
Murphy and Persichilli said in a statement that they were recommending people wear masks again because it is clear the delta variant is more transmissible, including among the vaccinated.
Concerns over rare inflammation of the heart lead FDA to request expanded trials among children
We have crushed this virus repeatedly like no other state in the nation, and we are proud to boast among the countrys highest vaccination rate, they said in the statement. But at this point, given where our metrics are now, we feel the best course of action is to strongly encourage every New Jerseyan, and every visitor to our state, to take personal responsibility and mask up indoors when prudent.
Those situations include indoors in crowded settings, where there is close contact with people who might not be fully vaccinated and when the vaccine status of others is unknown. They also recommend those who are immunocompromised or atincreased risk for severe diseasewear masks.
During his media briefing Monday on the pandemic, Murphy said that those who are vaccinated and get a breakthrough case of COVID-19 are less likely to be hospitalized or die. Of the 49 fully vaccinated who did succumb to the illness, many had other complicating factors, which kept them vulnerable to a COVID infection, Murphy said.
Lewis Nelson,chair of emergency medicine at Rutgers New Jersey Medical School, said wearing masks is necessary to help bring down the number of cases given so many remain unvaccinated and, at the moment, unwilling to get that protection.
Growing since mask mandate ended, COVID-19 transmission rate highest since last years second wave
When the CDC initially recommended that vaccinated people stop wearing masks indoors, they were clear that those who are unvaccinated or who have not developed natural immunity from previous infection with the virus should continue to wear masks, Nelson said. Although the current spike in COVID-19 cases is primarily in unvaccinated people, we cannot differentiate those who are vaccinated from those who are not. Therefore, all people, immune or not, should wear masks when they are in areas with high viral transmission. The slight increase in COVID infections among vaccinated populations, while generally fairly mild, further supports this recommendation.
Murphy and Persichilli said they reserve the right to take further measures, including another mask mandate, if the number of cases continues to rise and urged all those who have yet to be vaccinated to do so.
The vaccines turn COVID into a preventable disease, Murphy said Monday. Because of the vaccines, this is a pandemic, as weve been saying now for many weeks, among the unvaccinated.
ATHENS, July 29 (Reuters) - Greece's south Aegean islands were marked dark red on the European Centre for Disease Prevention and Control's COVID-19 map on Thursday after a rise in infections, meaning all but essential travel to and from the region is discouraged.
The cluster of 13 islands includes Greece's most popular destinations for foreign tourists - Mykonos, Santorini and Rhodes - which, combined, draw millions of people every summer.
Greek Deputy Civil Protection Minister Nikos Hardalias said later on Thursday Mykonos and Ios, another popular tourist destination, were "one step" away from authorities imposing restrictions.
He said the situation was also worrying on the islands of Zakynthos, Tinos, Lefkada, Santorini, Paros and Rhodes.
Greece, which depends heavily on tourism, had relied on promoting "COVID-free" islands to draw visitors back this summer, hoping a rebound in international travel would resuscitate the sector after its worst year in decades in 2020.
Despite a strong June in terms of arrivals and expressions of optimism from ministers and tourism officials, uncertainty remains over how the season will unfold. read more
"We're waiting to see how the (tourist) markets will react," said Manolis Markopoulos, president of the hoteliers association of Rhodes, referring to the decision of the ECDC, an agency of the European Union. More than 90% of tourists to the island are from abroad.
Germany, which this month listed Greece as a coronavirus risk area, and Britain, which has Greece on its "amber" list of countries requiring returning travellers to quarantine at home, are usually the biggest sources of visitors to Greece.
The dark red zones on the ECDC map help distinguish very high-risk areas and also help EU member states uphold rules requiring testing on departure and quarantine upon return.
Last week the ECDC downgraded Crete, Greece's biggest island and another popular destination, to the dark red zone.
Reporting by Karolina Tagaris and Lefteris PapadimasEditing by Toby Chopra and Peter Graff
Our Standards: The Thomson Reuters Trust Principles.
DES MOINES -Today, Governor Reynolds released the following statement following the Biden Administration issuing new COVID-19 guidance:
The Biden Administrations new COVID-19 guidance telling fully vaccinated Iowans to now wear masks is not only counterproductive to our vaccination efforts, but also not grounded in reality or common sense. Im concerned that this guidance will be used as a vehicle to mandate masks in states and schools across the country, something I do not support.
The vaccine remains our strongest tool to combat COVID-19, which is why we are going to continue to encourage everyone to get the vaccine.
I am proud that we recently put new laws in place that will protect Iowans against unnecessary government mandates in our schools and local governments. As I have throughout this pandemic, I trust Iowans to do the right thing.
While authorized vaccines have proven safe and effective in holding the line against COVID-19, they are not 100% effective. Reports of uncommon breakthrough cases among fully vaccinated Americans, coupled with the delta variant tearing through the country, threaten to undermine the fiercely fought wins against the pandemic.
For the fully vaccinated who do test positive, if you are at high risk for severe infection, health experts are now turning to Food and Drug Administration authorized, virus-fighting monoclonal antibodies in some cases. They are saying it's safe and beneficial for those who have been vaccinated, but get infected with COVID-19 nonetheless.
"Receiving antibody treatments in a timely manner could be the difference of ending up in the hospital or getting over COVID (quickly)," Dr. Shmuel Shoham, infectious disease physician at Johns Hopkins University School of Medicine, told ABC News.
Monoclonal antibodies are synthetic versions of the body's natural line of defense against severe infection, now deployed for after the virus has broken past the vaccine's barrier of protection. The therapy is meant for COVID patients early on in their infection and who are at high risk of getting even sicker to help keep them out of the hospital. This risk group includes people 65 and older, who have diabetes, high blood pressure, cardiac disease, obesity, asthma or who are immunocompromised.
Handout picture released by the Austral University of Chile showing scientists working at the universiy laboratory in the development of antibodies in Valdivia, Chile, on May 26, 2021. - Scientists from Chile and Bolivia are working separately on the development of antibodies obtained from alpacas and donkeys to treat patients with COVID-19.
It can be administered through an intravenous infusion, or a subcutaneous injection, which is less time-consuming and labor-intensive, and more practical in an outbreak situation.
The therapies still in use across the U.S., like Regeneron's antibody cocktail, has shown to hold up against the variants of concern, including delta.
It's a new use for a therapy whose authorization predates that of the vaccines.
"The trick is to proverbially cut the virus off at the pass," Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, told ABC News. "An ounce of prevention is worth a pound of cure."
Though a fraction of breakthrough cases have symptoms, the few that do may need backup to fight off the infection, experts say.
"There are exceptions. Everyone has seen a handful of patients who are vaccinated, you get very, very sick. Those are by and large, people with many risk factors, and perhaps people were vaccinated longer ago, with people in whom we don't expect the vaccine to work as well," Dr. Andrew Pavia, Infectious Diseases Society of America fellow, NIH COVID treatment guidelines panel member and chief of pediatric infectious diseases at the University of Utah School of Medicine said.
Clinical trials for monoclonal antibody therapies were conducted prior to vaccines' authorization, before shots started going into arms and far before breakthrough infections were a part of daily discussion. But the Centers for Disease Control and Prevention specifies that for vaccinated people who have subsequently contracted COVID, a vaccine should not preclude seeking further treatment.
"Prior receipt of a COVID-19 vaccine should not affect treatment decisions (including use of monoclonal antibodies or timing of such treatments," the CDC said.
The chances of an allergic or adverse reaction is low, experts said. Regeneron's product targets the virus, not a protein produced by the body, a company spokesperson said -- so, it likely wouldn't trigger a haywire immune response with an antibody "overdose" from both the vaccine and the monoclonal therapy. And clinical trial data has shown authorized monoclonal antibody therapies can sharply reduce hospitalizations and deaths by as much as 70%.
A Regeneron spokesperson said as long as a patient has tested positive for COVID and meets the other criteria to receive the treatment, they can receive the therapy.
CORRECTS LOCATION A health worker administers a dose of Janssen Johnson & Johnson COVID-19 vaccine at Dakar's Medina neighborhood, Senegal, Wednesday, July 28, 2021. In the midst of a third wave of the coronavirus pandemic, with many countries on the cusp, African health officials are racing to vaccinate populations that had before been reluctant or unable to access vaccines.
"We are not screening those patients out. If they have been vaccinated and come in testing positive and are at high risk for a more severe infection we are giving them monoclonals," Schaffner said. "I think that was decided pretty quickly."
It's a question of targeting the appropriate group of infected patients, experts said and it's not for anyone who has symptoms after testing positive. Doctors prescribe the therapy for patients with specific risk factors that make them unlikely candidates for fighting off the virus on their own. With your antibodies already being made to combat coronavirus, experts said another helping won't do as much good.
But Shoham calls it a "missed opportunity" for patients eligible to receive it -- who don't.
"If they had gotten a monoclonal antibody, their chance for hospitalization would have been significantly reduced," Shoham said.
"The vaccines are so good, that most people who have one or two risk factors that are vaccinated are less likely to become infected, and if they are -- the vast majority have done very well," Pavia said. "What we're trying to do is identify that small sliver of people with breakthrough infection that may get quite sick."
The antibody cocktail medications work best if it is delivered within days of a positive test or onset of symptoms. So, doctors recommend acting quickly after getting a positive test to seek treatment, if the high-risk criteria fit -- whether you have been vaccinated or not.
"This is a targeted treatment that is not for everyone -- it's not 'spaghetti at the wall' for when vaccines don't work," Schaffner said. "But this is good news on the therapeutic side."
ABC News' Eric M. Strauss contributed to this report.
July 29 (Reuters) - Canada and Mexico imported millions of doses of AstraZeneca's COVID-19 vaccine and offered them to the public without health officials properly inspecting the operations of the U.S. manufacturer, according to inspection records and the regulators involved.
The Baltimore plant belonging to Emergent BioSolutions Inc (EBS.N) was producing vaccines for both AstraZeneca Plc (AZN.L) and Johnson & Johnson (JNJ.N) under a $628 million U.S. government contract.
In late March, under pressure to help other nations access COVID-19 vaccines, the Biden administration released 1.5 million AstraZeneca doses to Canada, and 2.5 million to Mexico.
European regulators had certified Emergent's factory as complying with "good manufacturing practices," and on that basis both Canada and Mexico began using the vaccine, regulators in both countries told Reuters.
But the European Medicines Agency (EMA) told Reuters that the certification was based on a remote inspection that focused on a part of the facility that was not actually producing the AstraZeneca shots - a fact that has not been previously reported.
The U.S. Food and Drug Administration halted production at the factory three weeks later, after J&J's vaccine was found to be contaminated with material used in the AstraZeneca shots.
FDA inspectors later documented unsanitary conditions and poorly-trained staff at the plant, which had been rapidly overhauled to make vaccines during the pandemic. read more Production had remained halted, with tens of millions of doses of both vaccines in regulatory limbo.
Emergent said on Thursday the FDA was allowing it to resume production of J&J doses at the Baltimore plant after completing additional regulatory reviews. read more
No reports of illness have been linked to vaccines manufactured by Emergent, and regulators have not alleged that contaminated vaccines were given to anyone. Emergent said there has been no evidence of contamination in the AstraZeneca shots produced at its site.
But details of the flawed approval process show blind spots that can develop when national regulators share responsibility for overseeing a complex global pharmaceutical industry. Those were only exacerbated given the urgency of the pandemic.
"It's a risk, because who knows what the standards are that are being applied?" said Joel Lexchin, a Canadian professor and expert in drug regulation. Health Canada typically relies heavily on foreign regulators, he said. "It's a gap that exists outside of crisis times."
Emergent said in a statement that it "has worked with health officials around the world to ensure any vaccine drug substance we manufactured meets strict safety and quality requirements before being released."
AstraZeneca said vaccines manufactured by Emergent were subject to more than 40 tests to meet its requirements for safety, purity and quality, and that its manufacturing standards "are rigorously assessed and independently verified by regulators."
Health Canada told Reuters it is confident the vaccines it received were safe, pointing in part to AstraZeneca's quality control systems. Mexico health regulator COFEPRIS said it remains "confident that the approval process was carried out with all the necessary rigor."
Canada signed deals to formally recognize some other regulators' certifications as early as 2003, and the United States and Europe reached similar deals in 2019.
A EUROPEAN INSPECTION
Early in the vaccine rollout, the European Union was due to receive doses of the J&J vaccine made by Emergent. In early February, Italian officials conducted a remote inspection of the plant that only focused on areas where J&J production was taking place "and not the AstraZeneca vaccine, which was not manufactured at Emergent for the EU market," EMA said in a statement.
Health Canada said it assumed both products would be made to the same standard. "The quality systems assessed by the EMA for this product would be applicable to all similar products made at this site," it said in a statement.
This is the wrong approach, according to University of Ottawa professor Amir Attaran, who studies drug policy, including Health Canada's reliance on foreign regulators.
"It's precisely because they were similar (products) that cross contamination is a risk," he said. Canada was "out on a limb" approving AstraZeneca doses from the facility before the FDA, he said.
Health Canada said it reviewed test results and quality control steps for every vaccine lot sent to Canada.
Initially, Mexico's COFEPRIS told Reuters the FDA was responsible for certifying U.S. operations, but later confirmed that the factory had been certified by European regulators.
When Reuters shared the European regulators' statement that it had not assessed AstraZeneca production specifically, COFEPRIS said it would review the file, but remained confident in the approval process.
The Mexican regulator said vaccines went through quality control systems at Emergent, and twice more during the vial filling process handled by another contract manufacturer.
"When evaluating vaccines, the product and its entire production process are considered and examined," it said in a statement.
Emergent's contract with the U.S. government is the focus of a Congressional investigation, which unearthed documents that highlight early concerns about the Baltimore plant.
Soon after the Trump administration announced Emergent's contract last summer, its own vaccine officials visited the plant and wrote a report flagging inadequate staffing and training. The report warned of the need to strengthen quality oversight, a process that would "require significant resources and commitment."
The FDA, following a February 2021 visit to the plant, noted in a June memo that Emergent staff turnover was high and record-keeping inadequate. While European regulators said they were aware of that visit, Health Canada said it did not learn about it until last month.
An FDA spokesperson said the agency works closely with international partners, and that it notified various health authorities of its findings after its April 2021 inspection of the Emergent facility.
Emergent said it is still working with the FDA to release more of the already produced COVID-19 vaccine batches.
"We have manufactured tens of millions of doses that could be used to help vaccinate people around the world as the pandemic shows no signs of slowing down," the company said.
Reporting by Allison Martell in Toronto, Emilio Parodi in Milan, Francesco Guarascio in Brussels, Carl O'Donnell in New York and Cassandra Garrison in Mexico City; Editing by Michele Gershberg and Bill Berkrot
Our Standards: The Thomson Reuters Trust Principles.
A Cambodian army member vaccinates a person inside a red zone with strict lockdown measures, amidst the outbreak of the coronavirus disease (COVID-19), in Phnom Penh, Cambodia, May 1, 2021. REUTERS/Cindy Liu/File Photo
PHNOM PENH, July 29 (Reuters) - Cambodia is set to launch a lockdown in eight provinces bordering Thailand from midnight on Thursday, in a bid to prevent the spread of the Delta variant of the coronavirus in the Southeast Asian country.
Prime Minister Hun Sen signed an order late on Wednesday for the lockdown, which bans people from leaving their homes, gathering in groups and conducting business, except for those involved in operating airlines.
"The temporary lockdown... aims to prevent community-based transmission of the new COVID Delta variant," Hun Sen said in the order posted on Facebook.
Border checkpoints with Thailand will also be closed except to allow for the transport of goods and in emergencies, Hun Sen said, adding the lockdown was due to run until Aug. 12.
The provinces affected are Koh Kong, Pursat, Battambang, Pailin, Banteay Meanchey, Oddar Meanchey, Preah Vihear and Siem Reap.
Cambodia managed to largely contain the virus for most of last year, but an outbreak first detected in late February has driven up total cases to 75,152, with 1,339 deaths.
Neighbouring Thailand has also faced a stubborn outbreak driven by the Delta variant, which was first detected in India, and has repeatedly reported record numbers of daily infections in recent weeks.
Reporting by Prak Chan ThulEditing by Ed Davies
Our Standards: The Thomson Reuters Trust Principles.
What GAO Found
The Federal Emergency Management Agency (FEMA), Department of Transportation (DOT), and Department of the Treasury (Treasury), among others, continue to provide financial assistance to mitigate the effects of the COVID-19 pandemic.
Based on GAO's prior work examining responses to public health and fiscal emergencies, including the COVID-19 pandemic, GAO has (1) identified key lessons learned that could improve the federal response to emergencies, and (2) made several related recommendations, including ones that highlight the importance of applying these lessons learned.
For example, DOT has not developed a national aviation preparedness plan to coordinate, establish, and define roles and responsibilities for communicable diseases across the federal government. GAO recommended in 2015 that DOT work with federal partners to develop such a plan, but it has not taken any action. Without such a plan, the U.S. is less prepared to respond to future communicable disease events. In addition, FEMA has faced challenges collecting and analyzing data on requests for supplies, such as personal protective equipment, made through the federal government. In 2020, GAO recommended that FEMA work with relevant stakeholders to develop an interim solution to help states track the status of their supply requests and plan for supply needs. FEMA has not taken action on this recommendation, and until the agency develops a solution, states, tribes, and territories will likely continue to face challenges that hamper the effectiveness of their COVID-19 response.
In response to the public health and economic crises created by the COVID-19 pandemic, Congress provided billions of dollars across a range of agencies to mitigate the effects of COVID-19. This included billions to:
This statement describes: (1) the federal response and selected relief programs administered by FEMA, DOT, and Treasury and (2) lessons learned based on GAO's reviews of selected COVID-19 relief programs, including related recommendations and their implementation status. This statement is based on GAO's body of work on the CARES Act issued from June 2020 through July 2021.To update this information, GAO reviewed agency documentation; and interviewed agency officials, industry associations, and selected businesses that applied to these programs on the latest implementation efforts.
MADRID (AP) Spains prime minister on Thursday announced that existing measures to protect the most vulnerable from the pandemics economic fallout will be prolonged until the end of October.
Spain, one of the countrys that was hardest hit at the beginning of the health emergency, has extended subsidies for the unemployed and furloughs for companies that have gone out of business to try to cushion an economic drop of 11% of its gross domestic product in 2020.
As a national lockdown extended in March last year, the government also rolled out a series of social measures, including a ban on leaving impoverished families without utilities and a moratorium on forced evictions for those who saw their income vanish.
During a televised briefing on Thursday to summarize progress during the first 1 years of his left-wing coalition, Prime Minister Pedro Snchez said that the so-called social shield will be extended beyond the current Aug. 9 expiration date to Oct. 31.
The change will be approved by the Cabinet next week, Snchez said.
Our priority is to fight inequality and social exclusion, the prime minister said, adding that the emptying rural areas where population rates are diminishing are a top priority for his administration: Our goal is that nobody, neither territories nor people, is left behind.
Spain is facing the paradox of being one of the worlds leaders in the uptake of coronavirus jabs, with 55.7% of its 47 million residents already fully vaccinated, but it also has among the highest infection rates in Europe for the past two weeks.
New cases have spread mostly among people under 30, which are largely yet to receive their jabs, although the speed of contagion has plateaued in recent days. Vaccinated people can also become infected with the coronavirus in what are called breakthrough cases.
The country has reported 4.3 million confirmed COVID-19 cases and over 81,000 pandemic-related deaths.
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