The impartiality of the WHO's report into the origins of COVID-19 has been called into question after revelations three lead investigators have had previous involvements with Chinese-linked institutions, according to Sky's Sharri Markson.
The World Health Organisation’s (WHO) wrapped up its investigation into the origins of the disease last week after spending 28 days on the ground in Wuhan, China. Earlier this month, the WHO-led mission in China said it was not looking further into the question of whether the virus escaped from a lab, which it considered highly unlikely. The investigation also did not rule out the Chinese-propagated argument that the virus started elsewhere and entered Wuhan via frozen imported food products. On Friday, director general Dr Tedros Adhanom Ghebreyesus said a summary of their findings would be published next week and the US has said it wants to review the data. Ms Markson said it is critical the public has confidence in the investigation into origins of the disease that has killed over two million people worldwide. However, three of the lead investigators, Dr Peter Ben Embarek Peter Daszak and Doctor Marion Koopmans have links to the Chinese government. She said the public's trust in the report is undermined when some of the investigators have links to the country being investigated. "The Wuhan Institute of Virology did not open its books and patient details of the first 70 people who fell sick with COVID-19 were denied. No information on patient zero,” Ms Markson said. “The fact is COVID-19 might have spilled over naturally from bats to humans or via an intermediary host. “But it might have been leaked from a laboratory. “And we need independent investigators, with an open mind, to find the answers. “Not scientists who have been ticked off as okay by the Chinese Government.”Monday, February 15, 2021
Israel's Covid-19 Vaccinations Hold Lessons for U.S.
Israel has rolled out the fastest Covid-19 vaccination campaign in the world, inoculating more than 42% of its population since late December. The small country -- with roughly nine million people, about the same as New York City -- now aims to inoculate the majority of its population by March.
While Israel's vaccination campaign is relatively simple compared with the mass mobilizations needed by countries such as the U.S. that have many more people spread over a greater sweep of geography, the effort offers some clear lessons.
Dispatch Smaller Vaccine Shipments
The Pfizer Inc.-BioNTech SE vaccine must be administered within five days after it leaves the main storage center and within six hours after a diluent is added before five to six doses are extracted from a vial.
To cope with that short shelf life and to reach less-populated and isolated areas, Israel -- with Pfizer's approval -- devised a system to split the company's 1,000-dose packages into smaller batches of a few hundred each. Workers repackage the vials in workstations equipped with massive freezers.
Israel, like most other countries, began by giving priority to medical professionals, people over 60 and those with high-risk conditions. In early February. it expanded the campaign to everyone over 16, while more actively encouraging older citizens to get inoculated.
Use Dedicated Vaccination Sites
Many of the vaccine sites are at large venues such as sports arenas or are being set up in tents inside cities, away from clinics and hospitals, allowing more people immediate access. These dedicated vaccination centers are staffed by doctors and nurses from public healthcare providers, making staffing easier. Israel's four health maintenance organizations are also operating mobile vaccine stations and a drive-through site to increase access. Israel's military is also pitching in, sending 700 medics in the reserves to assist at 104 of nearly 300 vaccination sites.
Refine Administrative Acts
Israel's healthcare providers are reaching out early and often to those eligible to receive vaccines, via applications, text messages and websites.
Israel, which is providing the vaccine free of charge to everyone, is also developing a passport system that would allow those who have been vaccinated to show a certificate on their cellphone to avoid quarantining after travel and to access places such as event halls, arenas and restaurants.
Reach Out to Minority Groups
Ahead of the vaccine rollout, public-health officials lobbied the country's minority groups that would be less disposed to take the vaccine: the ultra-Orthodox and Israel's Arab population, which together make up about 33% of the population.
Public-health officials met with ultra-Orthodox rabbis and leaders in Arab communities to get them to back the vaccination campaign. Prime Minister Benjamin Netanyahu made a special effort to visit Arab towns as part of his public-relations campaign.
Public-health officials traveled to ultra-Orthodox towns to meet with rabbis and dispatched Arabic speakers to Arab towns to meet with health professionals. They outlined all of the available information to indicate that the vaccine is safe and effective. They secured the signoff of the ultra-Orthodox leadership, which issued a statement urging anyone who could to get the vaccine.
Early Data Suggests Significant Drop in Infections After Second Dose
A study by Clalit, Israel's largest healthcare provider, showed a 94% drop in symptomatic Covid-19 infections among 600,000 people who received two doses of Pfizer's vaccine.
The vaccinated group was also 92% less likely to develop severe illness from the disease, according to the study. It compared 600,000 people who got the vaccine with a group of the same size and similar medical histories that didn't.
Clalit said the study, which was carried out with a team from Harvard University, included 430,000 people who were between 16 and 59 years of age, and 170,000 who were over 60. It was the first of its kind to show such a high level of efficacy for Pfizer's vaccine for those aged 70 and higher due to the limited scope of the clinical trials.
The study shows that Pfizer's vaccine is very effective in real life one week after the second dose, said Prof. Ran Balicer, Clalit's chief innovation officer and one of the study's authors, in a statement published with the study on Feb. 14 . The vaccine is even more effective two weeks after the second shot, he said.
Pfizer says its vaccine only reaches full effectiveness after two doses.
Separately, researchers at the central-Israel based Weizmann Institute found that in relation to previous lockdowns, hospitalizations and serious illness among those first vaccinated -- meaning those 60 and older -- dropped 48%, while deaths decreased 50% among that group. For those aged 55-60, the next most-vaccinated group, researchers found a 36% decrease in hospitalizations and 30% decrease in serious illness.
"Gradually the groups that are further away from their vaccination start date become less and less hospitalized," said Eran Segal, a computational biologist at the Weizmann Institute of Science.
After imposing a third lockdown in December to contain a resurgence in infections, Israel has begun to loosen restrictions in recent days.
UK auditing Indian vaccine site amid scramble for shots
Britain's drug regulator is auditing manufacturing processes at Serum Institute of India (SII) which could pave the way for AstraZeneca's COVID-19 vaccine to be shipped from there to the UK and other countries, according to two sources close to the matter.
SII, the world's largest vaccine manufacturer, is currently mass producing the AstraZeneca vaccine, developed in conjunction with Oxford University, for dozens of poor and middle-income countries but not the UK, which has been getting its supply of the shot primarily from domestic facilities.
If the UK's Medicines and Healthcare products Regulatory Agency (MHRA) gives SII's manufacturing process for the Oxford/AstraZeneca shot a greenlight it would allow the drug to be exported to the UK and to other countries which recognise MHRA's clearances, one of the sources said.
Reuters could not determine what was the rationale for the audit. SII did not respond to a request for comment on it. The MHRA confirmed that an inspection was happening but declined further comment.
"Due to commercial confidentiality we do not comment on inspections that are still ongoing," the regulator's chief executive Dr June Raine said in a statement to Reuters.
The two sources, who asked not to be named as the matter is private, said the audit should be relatively routine for SII, as its site already supplies other vaccines to the UK.
The inspection comes as countries around the world scramble to secure vaccine supplies amid supply disruptions and delivery cuts from leading drugmakers such as Pfizer Inc, Moderna and AstraZeneca.
It was not immediately clear whether an MHRA approval would allow the UK or AstraZeneca to route SII volumes of COVISHIELD - the brand name under which SII markets the AstraZeneca shot - to the EU, which has been pressuring the UK for supply from AstraZeneca's facilities in the UK, amid shortages in Europe.
AstraZeneca executives told EU officials last week that to accelerate supplies to the bloc, it could provide it with some doses manufactured outside Europe, two EU sources told Reuters. One said the SII could be a supplier.
AstraZeneca, which has previously tapped SII to help fulfill some of its vaccine orders from Brazil, South Africa and Saudi Arabia, did not respond to a request for comment on whether it needs SII to help meet commitments in the UK, or in any other nations that would recognise an MHRA certification.
It was not immediately available to comment on the reported offer to supply the EU with shots from the SII.
INSPECTIONS
The EU's drug regulator, the European Medicines Agency (EMA), audits sites from which it plans to source medicines but during the global pandemic, with multiple COVID-19 vaccines being developed, it is also partly leaning on inspections carried out by some other international regulators.
"Inspection outcomes for Covid-19 vaccines conducted by the MHRA will be considered by EMA," said the regulator. Any such approved sites would also need an EMA sign off before they can export to the EU, the regulator told Reuters.
MHRA declined to comment on specifics, but Raine said it was collaborating "with international partners in response to the global pandemic and on matters of mutual interest."
The UK has expressed an interest in purchasing vaccines from SII, according to the second source, along with a government official in New Delhi. The two sources said the volumes or timelines for any such purchases were unclear.
A UK government spokeswoman said: "Any discussions that have taken place between the UK Government and India on vaccines are not related to securing extra vaccine supply to the UK."
The UK has so far ordered 100 million doses of AstraZeneca's vaccine.
"Most countries have approached us and India's government," SII told Reuters, but it did not comment on any UK outreach. "We are trying our best to meet demand, and supply the vaccine to as many countries as possible, keeping India as the priority."
SII's chief executive, Adar Poonawalla, told Reuters in late January, his family-owned firm was keen to support AstraZeneca's supply needs but its primary focus was on India and other poorer nations in Asia and Africa. He said at the time SII had no plans to divert supplies to Europe.
India may approve Russia's Sputnik V vaccine within next few weeks
India could approve Russia's Sputnik V vaccine against COVID-19 within the next few weeks, the RIA news agency cited India's ambassador to Moscow as saying on Monday.
Small human trials of the Russian vaccine have been ongoing in India, conducted by India's Dr. Reddy's Laboratories Ltd and supported by the Russian Direct Investment Fund (RDIF).
More Medicare Advantage plans offer supplemental benefits: study
The number of Medicare Advantage plans that offer supplemental benefits continues to grow, according to new data from the Better Medicare Alliance.
The analysis, conducted by Milliman, found the number of plans offering such benefits increased across 36 out of 41 categories from 2020 to plan year 2021. That includes increases across 15 of 17 traditional supplemental benefit categories, four of five new expanded categories and 17 of 19 supplemental benefits for the chronically ill categories.
For example, 57% of plans now offer a meal benefit, and 46% will cover members' transport to and from doctors' visits.
The most common benefits offered, according to the report, include vision (offered by 96% of plans), hearing (93%), fitness (92%) and dental care (87%).
“This analysis provides unique insight into the ways that Medicare Advantage continues to innovate and enhance benefit offerings, even in the face of the extraordinary circumstances presented by the COVID-19 pandemic,” said Allyson Schwartz, CEO of the Better Medicare Alliance, in a statement.
"The growth of extra benefits and lower out-of-pocket available to seniors, including those particularly targeted to individuals with chronic conditions, demonstrates the value that Medicare Advantage continues to deliver for millions of beneficiaries," Schwartz said.
For benefits targeting chronic conditions specifically, diabetics were the most targeted patient population, the study found. In the 2021 plan year, 293 Medicare Advantage plans offered lower cost sharing and/or additional benefits targeting members with diabetes, reaching close to 1.5 million people.
The number of plans offering supplemental benefits for members with behavioral health diagnoses also grew significantly in 2021, according to the analysis, growing from just five plans in 2020 to 135 plans.
In addition, benefits targeting chronic obstructive pulmonary disorder and congestive heart failure were also common, the study found.
South Korea cuts Q1 COVID-19 vaccination plan, restricts use of AstraZeneca shot
South Korea said on Monday it will not use AstraZeneca’s coronavirus vaccine on people aged 65 and older, reversing an earlier decision, and scaled back initial vaccination targets due to delayed shipments from global vaccine-sharing scheme COVAX.
South Korea had said it would complete vaccinations on 1.3 million people by the first quarter of this year with AstraZeneca shots, but it slashed the target sharply to 750,000.
The decision is largely due to adjustments in the supply timetable of the 2.6 million doses of AstraZeneca vaccine from COVAX, the Korea Disease Control and Prevention Agency (KDCA) said on Monday.
It did not mention any production issues in Europe for the delayed schedule, which it put down to administrative processes at COVAX, and reiterated that its plan to reach herd immunity by November remained in tact.
“We do not believe the adjustments in inoculations in February and March will impact our goal of herd immunity by November,” KDCA director Jeong Eun-kyeong told a briefing.
South Korea also reversed its earlier plan on the use of the AstraZeneca vaccine and said it would delay inoculation of the elderly using the shot until more efficacy data becomes available.
South Korean authorities said last week they would grant their first approval for a coronavirus vaccine to AstraZeneca, and would allow its use on the elderly, despite warnings from advisory panels about a lack of data on its efficacy in older patients.
Several European countries have warned that AstraZeneca/Oxford University’s shot should only be given to those ages 18 to 64, but the company has said it triggers a good immune response in older people.
South Korea’s first vaccinations will begin on Feb. 26, with healthcare workers and vulnerable residents, including the elderly, the first in line.
European consortium seeks big pharma partner for COVID-19 shot
A pan-European consortium developing a COVID-19 vaccine is in talks with big pharma to support the late-stage development of its shot and ramp up manufacturing, the head of German biotech firm Leukocare told Reuters.
Leukocare is working with Italy's ReiThera and Belgium's Univercells on a vaccine based on a so-called non-replicating adenoviral vector, the same technology that AstraZeneca and Johnson & Johnson have used.
Chief Executive Michael Scholl said the companies were talking to potential big pharma partners about whether they could provide additional manufacturing capacity, as well as help to advance their candidate through Phase III clinical trials.
"We as a consortium are definitely open and are also discussing with big pharma partners about how to leverage us," he said.
ReiThera, which developed the vaccine, has said it has capacity to produce some 100 million doses per year. The company secured 81 million euros ($98 million) in Italian funding last month after the government described results of a Phase I trial as encouraging.
The consortium hopes to start a mid-stage trial this month and move to late-stage testing in May, Scholl said.
Fellow German biotechs BioNTech and CureVac have partnered with Pfizer and Bayer respectively to help bring their vaccine candidates to market.
Getting a bigger player on board was not a pre-requisite for starting Phase III testing, but would be beneficial for the clinical trial process, Scholl said.
One question facing the next crop of COVID-19 vaccine developers is whether it remains ethical to offer a placebo to participants in late-stage trials, Scholl said, adding talks with regulators were ongoing.
Leukocare has helped develop a highly-stable liquid formulation of the vaccine, which can be stored at between 2 and 8 degrees Celsius for at least 12 months.
The company is also working with other COVID-19 vaccine makers, including those whose shots are already approved and others still in clinical trials, Scholl said.
This includes trying to solve questions, such as whether it is possible to stabilise vaccines at higher temperatures so they are easier to store and distribute, he said.
The company is also exploring an alternative type of vaccine packaging that would do away for the need to have glass vials, Scholl said, declining to give further details as the company is still in talks with regulators.
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