EU has shipped tiny percentage of planned COVID-19 shot donations

 EU countries have so far donated just a tiny portion of excess COVID-19 vaccines to poor nations, mostly AstraZeneca shots, less than 3% of the 160 million doses they plan to give away in total to help tame the global pandemic, an EU document shows.

The European Union has committed to helping inoculate the most vulnerable across the world but, like other wealthy countries, EU states have so far focused on buying shots to inoculate their own citizens, contributing to a shortage of vaccines elsewhere.

EU states, with a combined adult population of 365 million, have so far received about 500 million doses from drugmakers and expect nearly a billion by the end of September.

But as of July 13, they had donated less than four million shots, the internal document, compiled by the European Commission and reviewed by Reuters, shows.

In total, it says EU countries have committed to sharing about 160 million doses, mostly without preference about their destination. The tally of shipments and pledged total have not been reported before.

Brussels has previously said EU nations plan to donate at least 100 million doses by the end of the year. There is no timeline for the target listed in the document.

In a statement on Thursday, the EU Commission said member states were on track to exceed the initial target, with 200 million doses to low- and middle-income countries this year. It did not say how many had already been shipped.

According to the document, those distributed so far went mostly to countries and territories with a link to the donor as member states seek to boost relations with nearby countries and deepen diplomatic ties.

he small shipments are likely to stir the debate about how wealthy countries are sharing their surplus shots while poor countries still struggle to get supplies.

The World Health Organization has called on Western governments to donate shots to the COVAX programme it runs with vaccine charity GAVI to ensure fair and equitable distribution to the world's neediest.

The EU said on Thursday that most of the 200 million doses would be shared through the programme.

Many poor countries rely on COVAX for their vaccines, but it has so far delivered only 135 million shots globally and is highly dependent on donated doses. Plans to buy shots on its own were temporarily derailed by vaccine makers' production problems and export restrictions in India.

The EU has received enough vaccines to fully inoculate 70% of adults, while South Africa has given only 7% of its adult population one dose and Nigeria only 1%.

The EU shipments are also small compared with more than 15 million doses donated by Washington and shipped over the past month to countries in Africa, Asia and Latin America as part of the U.S. pledge to give away 80 million vaccines. A big portion of those have been through COVAX.

While the tally is effective from July 13, the numbers can change relatively quickly.

ALMOST ALL ASTRAZENECA

EU governments have repeatedly been urged by the EU Commission to speed up donations and share portions of all types of vaccines they receive, EU officials said.

But EU countries have so far promised to donate almost exclusively AstraZeneca shots, the document shows. Johnson & Johnson is the second most frequent choice for donations, although a large portion of pledges are for unspecified shots.

Many EU countries have set limits on the use of the AstraZeneca vaccine as well as J&J due to concerns about extremely rare blood clotting, reducing the capacity to use them.

The Commission spokesman said that all vaccines used in the EU were safe and could be donated.

Germany, the EU's largest country, has committed to donating 33 million doses, the document says, 30 million of which were AstraZeneca and J&J and the other three million yet to be specified.

German officials said donations would begin in August and confirmed the numbers and types of vaccines to be donated.

France is by far the EU's main donor in terms of pledges. It has promised 60 million doses, mostly to COVAX and largely without any preference on their final destination.

However it has so far delivered only about 800,000 doses, half of which went to its former colonies Senegal, Mauritania and Burkina Faso, the document shows.

The document does not clarify which vaccines Paris has donated or intends to donate.

An official with the French finance ministry said nearly five million AstraZeneca doses had been given so far via COVAX, and J&J and Pfizer vaccines will be donated by the end of the summer.

https://finance.yahoo.com/news/1-eu-shipped-tiny-percentage-141622743.html

FDA Classifies Philips Ventilator Recall as Most Serious

 The U.S. Food and Drug Administration on Thursday classified the recall of Philips' breathing devices and ventilators as Class 1, or the most serious type of recall, saying the use of these devices may cause serious injuries or death.

The agency said there have been 83 complaints regarding the products used to provide breathing assistance, but no injuries or deaths were reported for these issues.

The Dutch medical equipment company recalled some of its breathing devices and ventilators in June, as the foam used to dampen the machines' sound could degrade and emit small particles that irritate airways. The gases released may also be toxic or carry cancer risks, Philips had said.

https://www.usnews.com/news/us/articles/2021-07-22/fda-classifies-philips-ventilator-recall-as-most-serious

In LA, 20% Of Covid Cases Now Among Vaccinated Residents

 “The Delta variant is a game-changer,” said Los Angeles County Public Health Director Barbara Ferrer said on Thursday.

Ferrer announced that, as the Delta variant has become more prevalent in Los Angeles County, the percentage of infections happening among fully-vaccinated residents is also rising. In March, vaccinated people accounted for only 2% of all infections. In April that rose to 5%. In May, it was 11%. Stood at 20% in June. The rise coincides with the rise of the more transmissible Delta variant in the county, which now accounts for 84% of all variants recently identified.

LADPH

But, said Ferrer, there are still very important reasons for getting vaccinated. “If you’re vaccinated, the chance of you ending up in the hospital, winding up in the ICU, the chance of you winding up intubated are much less.”

One reason for the increase, she noted, “The more people who are vaccinated, the more people who will end up testing positive.” Currently, about 53% of L.A. County residents are vaccinated, so the proportion of vaccinated people to the overall population when compared to the proportion they make up of those who are newly infected reflects Ferrer’s logic.

The June 15 reopening may also have something to do with the spread among vaccinated people, she said. “When there’s more community transmission it effects…even those who have protection. If you’ve got more people around you who are infected, the more likely you are to get infected.”

“Those numbers will go up — including among vaccinated people,” she said, “until we get community transmission under control. Masking will help.”

Speaking of community transmission, Los Angeles continues to see steep increases with 2,767 new cases — up from 2,551 on Wednesday and 1,821 on Tuesday. The 7-day daily average case rate, which was 7.1 one week ago, has not virtually doubled to 12.9 per 100,000. That stat is considered one of the best indicators of the rise and fall of infections because it is both an average and not dependent on the number of tests administered.

LADPH

One important nuance in that case rate rise, is that young people seem to be driving it. While 12.9 per 100,000 is certainly high overall, according to L.A. officials the case rate for Angelenos between the ages of 18-29 is an eye-popping 25 per 100,000. Certainly a predominant, more transmissible variant is a part of that. But the vaccination rate certainly plays into it. While 58% of residents in that age range are vaccinated, the number is 92% among those 65-79.

LACDPH

https://deadline.com/2021/07/delta-variant-los-angeles-twenty-percent-covid-cases-vaccinated-people-1234798599/

Israel to become first in world to test Oravax oral COVID-19 vaccine

 Israel is about to become the first country in the world to test the oral COVID-19 vaccine developed by Oramed Pharmaceuticals, the company's CEO Nadav Kidron told The Jerusalem Post.

Oramed’s subsidiary, Oravax Medical, is gearing up to commence clinical trials of its vaccine at Sourasky Medical Center in Tel Aviv after receiving approval for its study protocol from the hospital’s Institutional Review Board. It is now waiting for approval from the Health Ministry, which is expected within a few weeks.

Oravax already completed GMP manufacturing in Europe of several thousand capsules that would be available for the Israeli trial and eventually in other countries.

Oramed is a clinical-stage pharmaceutical company based on technology developed by Jerusalem’s Hadassah-University Medical Center. In March, it announced a joint venture with India-based Premas Biotech to develop a novel oral vaccine. Together they formed Oravax. The vaccine is based on Oramed’s “POD” oral delivery technology and Premas’s vaccine technology.

Oramed’s technology can be used to orally administer a number of protein-based therapies, which would otherwise be delivered by injection. Oramed is in the midst of a Phase III clinical trial through the US Food and Drug Administration of an oral insulin capsule for Type 1 and Type 2 diabetes.

Premas has been working on developing a vaccine against the novel coronavirus since March.

The new Oravax vaccine candidate targets three structural proteins of the novel coronavirus, as opposed to the single spike protein targeted by the current Moderna and Pfizer vaccines, Kidron said.

As such, “this vaccine should be much more resistant to COVID-19 variants,” he said. “Even if the virus gets through one line, there is a second line, and if through the second line, there is a third.”

The vaccine is being tested in preclinical studies against COVID-19 variants, including the Delta one.

The company completed a pilot animal study and found that the vaccine promoted the development of Immunoglobulin G (IgG) antibodies and Immunoglobulin A (IgA). IgA is necessary for longer-term immunity.

The protocol for the inaugural Phase I/II trial that the company hopes to move forward with at Sourasky would involve 24 volunteers who have not yet been inoculated with another vaccine. Half of the group would take one capsule, and the other half would take two, Kidron said, adding that there is no placebo group because the goal is to measure the level of antibodies and other immunity indicators.

“The idea here is that we want to show proof of concept: that it works for people,” he said. “I pray and hope that we will. Imagine that we could give someone an oral vaccine and they are vaccinated. This would be a revolution for the entire world.”

With proof of the concept, “the whole world opens up,” Kidron said.

“An oral COVID-19 vaccine would eliminate several barriers to rapid, wide-scale distribution, potentially enabling people to take the vaccine themselves at home,” he told the Post. “While ease of administration is critical today to accelerate inoculation rates, an oral vaccine could become even more valuable in the case that a COVID-19 vaccine may be recommended annually like the standard flu shot.”

The advantages of an oral vaccine go beyond safety and efficacy because oral medications tend to have fewer side effects, Kidron said.

The vaccine can be shipped at refrigerator temperatures and even stored at room temperature, “making it logistically easier to get it anywhere around the world,” he added.

Finally, an oral vaccine would not require professional administration.

The Phase I/II trial is expected to take around six weeks from the time of recruitment.

If the trial is successful, Kidron said he plans to put the vaccine on an accelerated road to receive emergency-use approval in the countries that need it most, such as those in South America that have not been able to acquire enough vaccines to inoculate their populations.

The company would hold its Phase III trial with a limited number of volunteers and look for first approval in one of these “emerging markets,” Kidron said, and only later seek US Food and Drug Administration authorization.

“Israel and the US and some of the other richer countries were the first to get Pfizer and Moderna,” he said. “But it looks to me like the people behind in the race will take over by being the first ones to get the oral vaccine.”

https://www.jpost.com/health-science/israel-to-become-first-in-world-to-test-oral-covid-19-vaccine-674563

Ohio Doctors Urge Child Vaccinations

 Ohio’s COVID-19 cases are sharply climbing, and with the increased spread of the more contagious delta variant in the state, the state’s top doctor said Ohioans have two choices at this point in the pandemic.

“Either you get vaccinated, or you are going to get COVID-19,” Dr. Bruce Vanderhoff, chief medical officer of the Ohio Department of Health (ODH), said in a press briefing Wednesday.

Ohio’s case rate per 100,000 residents jumped from a low of 17.6 on July 7 to 37.8 this week, Vanderhoff said. On Wednesday, Ohio reported 785 cases. On Tuesday, the state reported 744 new cases, its highest daily case count since May.

Hospitalizations also went from 200 on July 9 to 348 July 20, according to ODH data, a 74% increase.

Health officials anticipated another spike in cases during the summer due to the delta variant, which has caused surging cases and hospitalizations in other states like Missouri and Texas and worldwide, Vanderhoff said.

The delta variant accounted for 36% of Ohio’s COVID-19 samples sequenced in the week ending July 3, and is expected to be even more present in more recent sample sets, Vanderhoff said.

Delta is becoming the predominant variant in the state, he added.

Dr. Amy Edwards, medical director of pediatric infection control at UH Rainbow Babies & Children’s Hospital in Cleveland, said Wednesday vaccination rates must increase for Ohio to stay on top of the spike.

“If you look even in states and countries where the vaccination rate is in the 70 and plus percent, this variant is so contagious that it’s finding all those little pockets of tiny unvaccinated groups and it’s making them sick. We have much bigger pockets than some of those other places,” Edwards said. “There’s no doubt about it: now that the delta variant is here, you will get sick from COVID.”

All three COVID-19 vaccines currently authorized appear to protect well against the variant, she added.

Health officials are particularly concerned about rising cases and hospitalization rates for younger age groups.

From May to June, 20% of cases were reported in people aged 20 and younger, Vanderhoff said. From October to December, just 12% of Ohio’s cases were in that age group.

Edwards said there is a misconception that COVID-19 does not affect children as much because older adults, on average, tend to have worse outcomes. But many children have been hospitalized with COVID-19 and even died, she said.

“If you look at the numbers, like the hospitalization rates, the school absenteeism from being sick with COVID and even the mortality from COVID in children, it’s about as bad as our worse flu season,” Edwards said. “So if you think about our worst pediatric flu seasons that make the news… that’s basically what COVID is. But it doesn’t stop when flu season stops. It’s been going all year.”

There are other risks for children as well, Edwards said, such as MIS-C, a rare inflammatory illness reported in some children and teens after developing COVID-19.

Just like other viruses, the coronavirus mutates and changes over time, becoming more contagious and potentially deadlier. The delta variant is 60% more contagious than the alpha variant, also known as B.1.1.7, and may cause more severe illness, Vanderhoff said.

Because of that, health officials are strongly encouraging people to get vaccinated before worse variants begin to circulate.

“I feel, truthfully, we are one variant away from this being worse for kids,” said Dr. Patty Manning-Courtney, chief of staff at Cincinnati Children’s Hospital. “Is that what we’re going to do? We’re going to wait until it is worse for kids, and then we might take it seriously and get vaccinated?”

All three vaccines are safe and highly effective in children, Manning-Courtney and Edwards said. So far, side effects from the vaccine, such as fatigue and arm soreness, seem to be milder for children than adults, Manning-Courtney said.

Edwards added while it may appear that the vaccines were developed quickly, the mRNA technology used in the shots from Pfizer and Moderna has been in development and heavily studied for years.

Vanderhoff emphasized that no corners were cut for any of the vaccines.

"Instead of months-long waiting periods between phases when paperwork could be prepared, the process moved. All the normal safety steps were taken in developing these vaccines," he said.

State health officials are putting together guidance for K-12 schools about masking, social distancing and other COVID-19 safety measures ahead of the new academic year. But health organizations have differing thoughts about universal masking in schools.

The American Academy of Pediatrics (AAP) recently recommended all students wear masks, regardless of whether they are fully vaccinated. Edwards, who is an AAP fellow, said she agrees with that guidance.

Vanderhoff said state health officials will evaluate all of the current guidance and make a recommendation to Ohio schools, but it will be up to individual school districts to make the final decision about safety measures to implement.

"We're actively looking very thoughtfully at recent guidance that came from the American Academy of Pediatrics just 48 hours ago, input from various stakeholders and guidance from the CDC," he said.
Columbus schools announced they will start school without a mask mandate in place, but that could change based on guidance from Columbus Public Health.

In Northeast Ohio, some school districts have already made decisions about mask requirements for the fall 2021 semester. The Cleveland Metropolitan School District will require all students and staff to wear masks for at least the first five weeks of the school year regardless of vaccination status, while Parma City Schools will not require masks for anyone.

https://news.wosu.org/coronavirus/2021-07-21/as-covid-19-cases-surge-with-delta-variant-ohio-doctors-urge-child-vaccinations

CIA head triples size of medical team probing cases of 'Havana Syndrome'

 CIA Director William Burns said the agency has tripled the size of the medical team investigating cases of “Havana syndrome” attacks.

Burns said he is “absolutely determined” to determine what is behind the mysterious attacks that have left government personnel with unexplained negative health effects.

“We still don't know for sure, but I am absolutely determined — and I've spent a great deal of time and energy on this in the four months I've been CIA director — to get to the bottom of the question of what and who caused this,” the director told NPR in his first sit-down interview with taking over leadership of the agency in March.

The mysterious illness first occurred in Havana in 2016, and has since shown up in a number of countries, leaving U.S. diplomats and spies with neurological symptoms, including vertigo, insomnia and cognitive difficulties.

Burns said there have probably been “a couple of hundred” cases of the mysterious illness since Havana in 2016, roughly 100 of which “my colleagues, my officers and family members have been affected.”

He confirmed that the agency tapped a “very experienced and accomplished senior officer” who led the hunt for Osama Bin Laden to head the agency’s effort on the Havana syndrome. The Wall Street Journal reported on the CIA’s pick on Wednesday.

He said he is “throwing out the very best we have at this issue” because of the risk it poses to CIA personnel and others across the U.S. government.

“So we're throwing the very best we have at this issue because it is not only a very serious issue for our colleagues, as it is for others across the U.S. government, but it's a profound obligation, I think, of any leader to take care of your people, and that's what I'm determined to do,” Burns said.

he director said the “first challenge” in the country’s effort against the syndrome is “to make sure people are getting the care that they deserve. He said the agency has reduced the amount of time it takes for officers to get into Walter Reed National Medical Center from eight weeks to less than two weeks.

When discussing the causes of the syndrome, Burns said there is “certainly a very strong possibility” that the illness is being caused by someone taking action.

“The National Academy of Sciences, a year ago, in a very extensive report that they did, suggested that the most plausible theory for what caused this was some form of directed energy, and that sort of narrows, then, the number of potential suspects who could have used this, have used it historically and have the reach to do this in more than one part of the world, too,” Burns continued.

https://thehill.com/policy/technology/564428-cia-director-triples-size-of-medical-team-probing-cases-of-havana

CDC panel weighs whether to recommend boosters for immunocompromised

 An advisory panel for the Centers for Disease Control and Prevention (CDC) weighed whether to recommend booster COVID-19 vaccines to people who are immunocompromised during a Thursday meeting. 

A CDC epidemiologist presented the Advisory Committee on Immunization Practices (ACIP) with small studies involving immunocompromised people receiving a third shot that suggested the dose “may enhance antibody response in some.”

But the panel did not make an official recommendation on booster shots for the population as its experts are still in the process of reviewing available data. 

The emerging data across four studies showed that among the immunocompromised people who had no antibody response to the initial two vaccine doses, 33 to 50 percent developed an antibody response with an additional dose.

About 2.7 percent of American adults are considered immunocompromised, including people with cancer, those with HIV and those who have had organ or stem cell transplants.

People with weaker immune systems are more likely to fall severely ill from COVID-19, a fact that has prompted calls for the at-risk group to get additional COVID-19 shots.

Sara Oliver, a medical epidemiologist with CDC's National Center for Immunization and Respiratory Diseases who presented the data, noted that antibody response data does not “tell the full story” on vaccine protection but still offers the panel information.  

Several ACIP voting members and liaisons expressed concerns that immunocompromised patients are taking matters into their own hands by getting additional shots instead of waiting for the panel’s recommendation. 

“I am concerned about them doing this kind of in an unsupervised fashion,” said Camille Kotton, a transplant-medicine physician at Massachusetts General Hospital. “But as it is right now, due to regulatory issues we are not allowed to recommend additional doses, so patients are really just doing what they think is best.” 

“Our hands are really tied with the current regulatory situation, and that is a challenge,” she added.

Pablo Sanchez, a professor of pediatrics at Ohio State University, acknowledged that they “obviously need more data” on how the booster shots work for people with specific immunocompromised conditions. 

But he added, “It seems to me that the issue is almost running away from us already.”

There is not another ACIP meeting currently scheduled although the panel is expected to meet in August. 

In the meantime, the CDC advised that fully vaccinated immunocompromised people continue to take safety precautions including wearing masks, avoiding crowds and social distancing.

https://thehill.com/policy/healthcare/564421-cdc-panel-weighs-whether-to-recommend-boosters-for-immunocompromised