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Thursday, May 6, 2021

Half of eligible Texans unvaccinated, supply exceeds demand: Texas shifts vax plans

“It’s going to be a harder process to get the next group of individuals immunized,” Lakey said. “The ones that were really anxious [to get vaccinated], I think, have been immunized at this point.”

“I think what we’re doing is working,” Huff said. “We don’t get a lot of numbers, but I do think we’re reaching the people that need to be reached and, if anything, that helps spread the word.”

https://www.texastribune.org/2021/05/03/texas-covid-19-vaccinations/

What’s the future of vaccines linked to rare clotting disorders?

 Vaccine regulators have delivered a clear verdict: In most settings, the benefits of the COVID-19 vaccines made by AstraZeneca and Johnson & Johnson (J&J) far outweigh the small risk they will cause an unusual and sometimes deadly clotting disorder. But many questions remain about who is most at risk, how the risk-benefit calculus changes when cases fall, and what the side effects mean for the future of these vaccines, which use adenoviruses to ferry the gene for SARS-CoV-2’s spike protein into human cells.

A major concern is how the rest of the world will respond to some European countries’ moves to limit the use of the AstraZeneca and J&J vaccines, and the brief suspension of the J&J shot in the United States. The AstraZeneca vaccine—named Vaxzevria, or Covishield when it’s produced by the company’s Indian partner, the Serum Institute of India—is the cornerstone of the COVID-19 Vaccines Global Access (COVAX) Facility, a scheme aimed at vaccinating billions in the developing world. J&J is expected to provide hundreds of millions of doses of its one-shot vaccine to COVAX this year.

“Once there are clear policies from the West regarding in what age groups to use these vaccines, it’s going be very hard to recommend anything different here,” says John Amuasi, an epidemiologist at the Kwame Nkrumah University of Science and Technology in Ghana, one of the first countries in the world to receive the AstraZeneca vaccine through COVAX. But if no other vaccines are available, limiting use of these could ultimately cause many more COVID-19 cases—and deaths.

How big is the risk, and who is most vulnerable?

Signs the AstraZeneca vaccine could lead to an unusual reaction that causes clots throughout the body, accompanied by low levels of platelets, first surfaced 2 months ago. Many of the first cases of what scientists now call vaccine-induced immune thrombotic thrombocytopenia or thrombosis with thrombocytopenia syndrome (TTS), were in women under the age of 60. But that may just be because many European countries used the shots in health care workers and educators, most of whom are women and under age 65. Indeed, the gender imbalance has started to even out as more cases came to light. Among 209 people affected in the United Kingdom, 87 were men and 120 women; 139 cases were in people younger than 60. Overall, one in roughly 120,000 AstraZeneca shots has triggered the side effect in the country.

In Sri Lanka, the health minister told Parliament last month that at least six people had developed the clotting disorder among nearly 925,000 who received the vaccine, or one in 150,000 recipients. Germany has reported cerebral venous thrombosis (CVT), an unusual type of stroke that is characteristic of TTS, in roughly one in 76,000 recipients of the vaccine.

The rate was higher in Norway and Denmark, where roughly one in every 40,000 AstraZeneca vaccine recipients developed CVT, with the frequency of other clotting events possibly even higher. Whereas most European countries have recommended using the vaccine in older recipients, Norway and Denmark have recommended against using the vaccine at all for now. Denmark announced today it will not use J&J’s vaccine either.

The symptoms of TTS closely resemble a condition called heparin-induced thrombocytopenia (HIT), a rare autoimmune reaction that is triggered by the blood thinner heparin. Despite decades of research, doctors can’t predict who’s at risk of HIT; it seems to affect men and women, old and young alike.

The same may be true for TTS. “We cannot identify any predisposing factors,” Beverley Hunt, a hematologist at King’s College London, said on a 29 April webinar sponsored by the Danish Health Authority. There’s no sign that a history of blood clots or other clotting risk factors—such as taking birth control pills—increases the risk of TTS; even people who have previously had HIT don’t seem at a higher risk. And it is not clear whether the risk differs between the first and second doses of the AstraZeneca vaccine.

Across countries, roughly one in five patients with the clotting disorder has died. Health authorities hope publicizing the early signs of TTS and how to treat it can help prevent fatalities. But the severe clotting is difficult to treat outside of a well-equipped hospital, so many recipients in rural areas or regions with limited health infrastructure will have little recourse.

Do other vaccines using adenovirus vector have issue?

Early data from the United States suggest J&J’s vaccine does. So far, U.S. regulatory agencies have reported 15 cases of TTS in about 7 million vaccinees. That’s a lower frequency than the one seen in Europe with the AstraZeneca vaccine, says Klaus Cichutek, president of Germany’s regulatory agency, the Paul Ehrlich Institute. But J&J’s rollout is just beginning in Europe, he cautions: “With vaccinations starting here, we will see whether these numbers hold true.”

Less data exist on the other two adenovirus-based vaccines, Russia’s Sputnik V and Convidecia, made by the Chinese company CanSino Biologics. CanSino said in mid-April it is watching for similar clotting disorders and had not received any reports. Fewer than 1 million shots had been given then; the vaccine rollout is just beginning in Malaysia, Pakistan, Mexico, and other countries this month. The makers of Sputnik V say there have been no cases of clotting disorders among recipients. But it is unclear how many people have received the vaccine, and many of the countries where it has been distributed may be hard-pressed to diagnose the syndrome.

Before COVID-19, the only adenovirus-based vaccines in use were Ebola vaccines developed by J&J and by CanSino. There were no reports they caused the rare side effect, but it is unclear how many people received the Chinese vaccine. The J&J shot has been given to about 200,000 people, according to the company. Stanley Plotkin, a veteran vaccine developer and an emeritus professor at the University of Pennsylvania (UPenn), notes that low platelet counts have been described after adenovirus infections, which typically cause the common cold, but can occasionally trigger severe infections. So it’s possible, he says, that the problems with AstraZeneca and J&J may be related to their adenoviral vectors. “But that has to be settled in the laboratory.”

How do AstraZeneca vaccine’s risks, benefits stack up?

For an older person in an area with lots of infections, the benefits vastly outweigh the risks. For a young person in a place where the pandemic is ebbing, they may not.

Guidance issued by the European Medicines Agency on 23 April showed vaccinating 100,000 people ages 80 and older in an area with high infection rates—886 infections per 100,000 people per month, the level seen in Europe in January—would prevent 1239 hospitalizations and 733 deaths over a period of just 4 months (see tables, below). At the low infection rate seen in September 2020—55 per 100,000 per month—151 hospitalizations and 90 deaths would be prevented. In both scenarios, only 0.4 cases of TTS would be expected in those 100,000 people.

By contrast, vaccinating 100,000 people age 20 to 29 would lead, on average, to 1.9 cases of the blood clotting disorder. But it would not prevent any deaths from COVID-19, although it would prevent 64 hospitalizations in an area with high infection rates.

There are other things to consider, however, says Jeremy Farrar, an infectious disease expert who heads the Wellcome Trust. “Don’t underestimate the impact of Long COVID,” he says. “These vaccines do appear to protect against that as well.” And vaccinating younger people not only protects them, but also helps keep them from spreading the virus to more vulnerable people in a community.

Weighing risks and benefits

The benefits of the AstraZeneca COVID-19 vaccine—in hospitalizations and deaths prevented over a period of 4 months—far outweigh the risks of a rare clotting disorder for most age groups, both when infections in a region are high (top) or low (bottom). All data are per 100,000 people vaccinated.

High infection rate
AgeHospitalizations preventedDeaths preventedCases of blood clots with low platelets
20–296401.9
30–398131.8
40–49122102.1
50–59208141.1
60–69324451
70–795471720.5
80+12397330.8
Low infection rate
AgeHospitalizations preventedDeaths preventedCases of blood clots with low platelets
20–29401.9
30–39501.8
40–49612.1
50–591011.1
60–691931
70–7945140.5
80+151900.8
EUROPEAN MEDICINES AGENCY

In many places, the decision is not whether to vaccinate, but whether to use AstraZeneca now or wait for another vaccine to become available. Denmark based its decision to stop using AstraZeneca and J&J altogether in part on the availability of alternatives such as the Pfizer vaccine. Hong Kong, which canceled its order of AstraZeneca, said it already had enough doses of other vaccines.

Even a long wait for an alternative may be worth it if infections are low. In Norway, the risk of dying from TTS for women age 45 to 49 is equivalent to the risk of dying from COVID-19 over the next 79 weeks, assuming the infection rate stays the same, Camilla Stoltenberg, director general of the Norwegian Institute of Public Health, told the 29 April webinar. “That group will have alternative vaccines, maybe with a small delay but nothing close to 79 weeks,” she said.

Is the calculus different in low- and middle-income countries?

In the coming, crucial months, the AstraZeneca vaccine is one of the great hopes in the struggle toward vaccine equity—ensuring that poorer countries will be able to vaccinate their populations as well. Many of them can’t afford the messenger RNA vaccines produced by Pfizer and Moderna, which are also more difficult to store and distribute because they need to be kept at a very low temperature.

But restrictions on the use of the AstraZeneca vaccine in wealthy countries could tarnish its reputation globally—and slow or even block the plan to vaccinate the world. “I think we’ve got ourselves into a really difficult position,” where it looks like there’s “one vaccine for the rich world and a different vaccine for the poor world,” Farrar says.

“Information travels, and regulators in other countries feel pressure to say, ‘We’re not giving our population a second-class or a poor-quality product,’” adds Ashish Jha, dean of the Brown University School of Public Health. The fact that 70% of Africa’s population is under 30, an age group that no longer gets AstraZeneca in Europe, only serves to highlight the inequity, Jha says. Yet for African countries to shun the vaccine would be a terrible decision, he says, because it is very effective and safe in the vast majority of cases.

The European pause has already slowed vaccinations in the Democratic Republic of the Congo (DRC). The country received 1.7 million doses from COVAX in early March but delayed its rollout when European countries hit pause. Vaccinations started on 19 April, but the government said last week it would return 1.3 million doses because it can’t use them before they expire in June. (The vaccine will be redistributed to other countries.)

The situation reminds some observers of their experience with RotaShield, a vaccine protecting children from rotavirus. The vaccine in rare cases led to intussusception, a condition in which a part of the intestine folds in on itself, leading to a potentially fatal bowel obstruction. In the United States, where rotavirus infections can easily be treated, government authorities in 1999 recommended stopping use of Rotashield. (Wyeth, its manufacturer, had already withdrawn the vaccine from the U.S. market by then.)

At some point, we’re going to need a global strategy that shifts away from the AstraZeneca vaccine towards others.

Ashish Jha, Brown University School of Public Health

The decision made many developing countries wary of the vaccine, says pediatrician and vaccinologist Paul Offit of UPenn’s Perelman School of Medicine, even though in their case the benefit vastly outweighed the risk. Offit recalls a 2000 World Health Organization (WHO) meeting about Rotashield: “Country after country stood up at the end of that meeting, and said, and I quote, ‘If it’s not safe for America’s children, then it’s not safe for our children.’” A new vaccine became available 7 years later. “But 2000 children died a day for 7 years,” Offit says.

“I think RotaShield traumatized a generation of vaccine and immunization people,” says WHO epidemiologist Kate O’Brien. But so far, there has been little sign of countries refusing the AstraZeneca vaccine because of other countries’ decisions, she says. And since the Rotashield drama, lower income countries have become more confident and experienced in making regulatory decisions for their own context, O’Brien says. “I think we’re in a really different place now.”

Of course, the public also has to want a vaccine. Gagandeep Kang, a virologist at the Christian Medical College in Vellore, India, says many patients are calling her about the clotting disorder. “So it is affecting vaccine confidence to some extent,” she says. “But I also don’t think that we really have a choice, because we don’t have the infrastructure to distribute the Pfizer and Moderna vaccines.”

In Ghana, “It’s difficult to tell how people think about this vaccine, because it’s not here,” Amuasi says: The country has run out of doses to administer, a far bigger problem than safety worries. Amuasi received his first shot earlier this year, but his appointment for the second shot had to be canceled because the country has no more doses. Ghana is scheduled to receive 350,000 of the doses going unused in the DRC in the coming days.

What is the future of the adenovirus vector vaccines?

Once the global pandemic begins to retreat, the relative importance of even a small vaccine risk will increase. As other inexpensive, easy-to-distribute shots based on different technologies are developed, adenovirus-based vaccines will play a smaller role. “At some point, we’re going to need a global strategy that shifts away from the AstraZeneca vaccine towards others,” Jha says.

Such vaccines are already being developed in Cuba, Kazakhstan, Mexico, and elsewhere, notes Hilda Bastian, an independent scholar of evidence-based medicine. “A lot of these countries are coming up with their own answers. It’s just been slower,” she says. If these new vaccines are approved and gain trust, “then this time next year could look very different,” she says.

https://www.sciencemag.org/news/2021/05/what-s-future-vaccines-linked-rare-clotting-disorders-science-breaks-down-latest

Most of NYC Remains Undervaccinated As COVID Restrictions Lift

 “Free Covid test! Free vaccine! Have you gotten your vaccine?”

One afternoon last week, Humaira Choudhury called forth outside the East New York office of the nonprofit where she works, catching the attention of Johnny Flynn, 63, who lives around the corner. Like most residents in Brooklyn’s 11208 zip code, Flynn had yet to get his first COVID-19 shot—though not due to a lack of interest. It had just proven more difficult than he anticipated.

Flynn initially inquired at his local pharmacy, but they weren’t offering it. “They said ‘try online, something will come up,’” he recalled, but he struck out there, too. “So, I’ve just been waiting.”

As the city moves toward Mayor Bill de Blasio’s goal of vaccinating 5 million people by July 1st, it’s becoming increasingly important to figure out why some haven’t been able to get vaccinated or have put it off. Health experts are citing hesitancy as a major reason why herd immunity may not be achievable in the U.S. But barriers to access are also keeping people away from shots. Labor organizations in New Jersey, for example, are coordinating late-night shots for warehouse employees.

About 44% of New York City residents have received at least one COVID-19 shot, and about 32% are fully vaccinated. But some neighborhoods are much further along than others. In wealthier and whiter zip codes, more than two-thirds of residents are at least partially vaccinated (one zip code in the Financial District is at 89%). Most neighborhoods in upper Manhattan, Queens, The Bronx, Brooklyn and Staten Island are well below half their populations being fully vaccinated.

East New York's three zip codes, on average, sit at 34% with at least one shot and 24% fully vaccinated—even as the governor and mayor lift restrictions on social venues and city offices. By the time Israel rolled back its lockdown in mid-March, 50% of its residents had been fully vaccinated, and 60% had taken one dose. Israel's population is similar in size to New York City.

Community organizations, such as the Bangladeshi American Community Development and Youth Services (BACDYS) where Choudhury works, are striving to boost the vaccination rate in their neighborhoods—person by person. BACDYS is culturally aligned with the local Bengali and Muslim populations in East New York but also serves the broader area, which is predominantly Black and Latino. But addressing people’s complex needs and concerns can be a slow process.

Flynn was intrigued when Choudhury handed him a flyer with a list of vaccine sites around the city that now allow walk-ins. But, with limited mobility following a stroke, he said the locations were all too far away. BACDYS was planning a vaccine pop-up but hadn’t yet locked down a date. Choudhury took down Flynn’s number and said she’d keep him in the loop. “If they do it, I’ll go ahead quick,” Flynn said.

Now that the city has vaccinated the “eager group” with the time and enthusiasm to get their shots quickly, it’s essential to focus on making the process more convenient, said Dr. Wafaa El-Sadr, professor of epidemiology and medicine at Columbia University and director of ICAP. She recommended deploying trusted messengers to distribute information about the vaccines and the shots themselves.

When it comes to convenience, it’s a matter of addressing practical impediments, “whether they're financial gaps or transportation issues or mobility issues or language issues or access to the Internet,” said El-Sadr.

After months of making people navigate a maze of websites and phone numbers to get an appointment for a COVID-19 shot, the de Blasio administration announced on April 23rd that it would start allowing walk-ins at all city-run sites. State officials mimicked this decision days later.

“We do need to do more work in the communities hardest hit by COVID,” de Blasio said at a press conference on April 29th. “What I’m finding is the more we make vaccination convenient, the better we’re doing.”

Those working on expanding vaccine access say the move could be a game-changer.

“The online registration was a challenge because people don't necessarily have the time to navigate that or the access to the appropriate computer,” said Colette Pean, executive director of the East New York Restoration Local Development Corp. “And the hours were a challenge because you might get an appointment that doesn't match your work hours or your child care. So walk-ins are always better.”

So far, walk-ins haven’t reversed the downward trend in demand for the COVID-19 vaccines—as judged by the number of New York City residents receiving their first doses every day. Some groups are much harder to reach than others, such as the 500,000 undocumented people in the city.


“We have a lot of clients that are not willing to show photo I.D.,” said Afsana Monir, executive director of BACDYS. “We try our best to tell them it's fine; it’s not going to be shared. They’re like, ‘No, they're going to put my name in the system.’”

The rollout has not completely stalled in East New York, with the portion covered rising about 6% in two weeks. But because the city does not provide data on how vaccination rates are changing in zip codes from week to week, it’s hard to compare the rate of progress in different communities and target interventions accordingly, said Dr. Tom Frieden, former director of the Centers for Disease Control and Prevention and one-time commissioner of the city’s Health Department. He said cumulative vaccination rates only show part of the picture.

“What gets measured can get managed better,” Frieden said. “I know they’re trying hard in New York, but they’re not achieving the results that are needed.”

Primary care doctors can help push the effort forward, Dr. El-Sadr said. After giving private practices a minimal part during the early months of the rollout, the state recently began allocating doses to doctors in the SOMOS Community Care network.

But people living in low-income communities often have less access to primary care, and benefit from receiving health information and services through community activities, said Pean. She noted that there was food, free masks, blood pressure screenings, and assistance with setting up vaccine appointments at a recent event hosted by Brookdale hospital.

“In a community that has so many health problems, the whole discussion is how do we get into preventive health, of which the vaccine is one aspect,” Pean said.

Conducting this work requires resources, which are not distributed evenly. East New York Restoration and BACDYS are among seven organizations that recently won $10,000 each from the Brooklyn Community Foundation to promote vaccine access and address hesitancy.

 Only 25% of Far Rockaway residents have gotten their first shot. 

But over in Far Rockaway, Queens, Jeanne DuPont, executive director of the community organization RISE, says she lacks the resources she needs to do aggressive outreach. Only 25% of Far Rockaway residents have gotten their first shot, compared with 71% in wealthier, whiter Breezy Point at the other end of the peninsula.

DuPont said she tried unsuccessfully to convince the city to send over a mobile vaccine van or help her turn her building, which is no longer being used for in-person activities, into a hub.

“Out on the street, when I talk to people and ask them about it, they tell you that they don't feel comfortable getting vaccinated,” said DuPont. “And that includes kids in our program. That includes families. There has to be more people on the ground doing education about vaccinations and also literally getting people vaccinated.”

A city spokesperson countered that Far Rockaway’s 11691 “has multiple vaccination resources, including a hub and additional sites, as well as a pharmacy. Appointments are available now, and we encourage everyone to roll up their sleeves and get vaccinated as soon as possible.”

The city has launched more initiatives to penetrate deeper into lagging communities. In March, the de Blasio administration announced that it is setting aside funds for groups that can coordinate networks of local stakeholders to educate people about vaccines and direct them to other resources related to COVID-19 recovery. The city is still targeting 33 neighborhoods first identified by the mayor’s Taskforce on Racial Inclusion and Equity when disparities in vaccine access became apparent in January.

The question is whether all of these efforts will be enough to get New York to herd immunity without leaving pockets of the city behind that could be vulnerable to future spread. Citywide, some 31% of white New Yorkers have gotten at least one dose, compared with just 17% of Black people and 19% of Latinos–a trend that mirrors racial disparities nationwide. Based on existing trends, researchers from Stanford University predicted that people of color in New York state would reach 75% vaccine coverage three to four weeks after whites–leaving them exposed to the virus for longer.

https://gothamist.com/news/most-new-york-city-remains-undervaccinated-covid-restrictions-lift

Walmart, Sam’s Club accept walk-ins for COVID-19 vaccine at all store pharmacies

 Walmart and Sam’s Club stores across the United States have expanded access to the COVID-19 vaccine for employees and customers.

The retail giants on Tuesday announced it will offer the Johnson & Johnson, Pfizer and Moderna vaccines to people via appointment or walk-in.


Walmart Pharmacies are open seven days a week, and Sam’s Club Pharmacies are closed on Sundays. People wanting to get a shot from Sam’s Club do not have to be a member.

Those who want to make an appointment can do so at walmart.com/COVIDvaccine or samsclub.com/covid. People who schedule an appointment can complete their pre-vaccination paperwork online.

The expansion comes amid an effort to get more Americans inoculated as the demand for vaccines has waned.

“Now that supply and eligibility have expanded, it’s even more important for us to reach underserved and vulnerable populations to ensure equitable distribution of the COVID-19 vaccine,” Dr. Cheryl Pegus, the executive vice president of Health & Wellness, said in a news release. “Widespread vaccination is the only way we will eventually end the pandemic and help our country reopen, and we don’t want anyone to get left behind as we enter this new chapter in our fight against COVID-19.”

Employees are encouraged but not required to get the vaccine. The company is providing employees with two hours of paid time to get an inoculation and allowing three days of paid leave for those experiencing side effects.

https://www.ksat.com/news/local/2021/05/04/walmart-sams-club-accepting-walk-ins-for-covid-19-vaccine-at-all-store-pharmacies/

Wednesday, May 5, 2021

US pharma body disappointed over decision to support COVID-19 vaccine patent waiver

US pharmaceutical trade body has expressed disappointment over the decision of the Biden administration to support India and South Africa’s proposal before the WTO to temporarily waive anti-COVID vaccine patents to boost its supply. PhRMA which represents America’s leading innovative biopharmaceutical research companies has said that the ”decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.

PhRMA companies are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested nearly USD 1 trillion in the search for new treatments and cures, including an estimated USD 83 billion in 2019 alone. (PhRMA) president and CEO Stephen J Ubl said this change in longstanding American policy will not save lives.

It also flies in the face of President (Joe) Biden’s stated policy of building up American infrastructure and creating jobs by handing over American innovations to countries looking to undermine our leadership in biomedical discovery, he said. This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials. These are the real challenges we face that this empty promise ignores, Ubl said.

In the past few days alone, we’ve seen more American vaccine exports, increased production targets from manufacturers, new commitments to COVAX, and unprecedented aid for India during its devastating COVID-19 surge, he said. Biopharmaceutical manufacturers are fully committed to providing global access to COVID-19 vaccines, and they are collaborating at a scale that was previously unimaginable, including more than 200 manufacturing and other partnerships to date. The biopharmaceutical industry shares the goal to get as many people vaccinated as quickly as possible, and we hope we can all re-focus on that shared objective, he added.

House Ways and Means Committee Republican leader Kevin Brady said that the world needs COVID vaccines now, but it shouldn’t be done by damaging the pathway to new vaccines and cures the world will need in the future. Looking ahead to the next pandemic, it is dangerous for America to consent to strip away patents on lifesaving COVID vaccines now that cost businesses billions of dollars to develop at a historic pace – and to reward China with access to US innovation for a world pandemic China created, he said.

The better solution to help our global neighbours is to solve the very real logistical hurdles slowing access to these vaccines, not undermine the incentives to develop them, Brady said. Nurses in the US on the other hand applauded the decision.

The welcome statement by President Biden’s US Trade Representative Katherine Tai joining this effort is a landmark decision that is also a tribute to healthcare and human rights activists, and nurses in particular, around the world, who have been pressing for this humanitarian step, said National Nurses United (NNU) president Jean Ross. As nurses on the front lines, we can tell you with absolute certainty: People are dying and will continue to die because of strict IP laws that are preventing the generic production of COVID-19 vaccines, said NNU executive director Bonnie Castillo.

There is no time to waste; we need to urgently scale up the manufacturing of vaccines, and to do that, the WTO must grant this waiver, he said. In a statement, KEI, a civil society organization that is at the forefront of IP waiver demand, applauded the decision by Tai to actively participate in text-based negotiations at the World Trade Organisation (WTO) for a waiver of intellectual property protections for COVID-19 vaccines. This decision isolates the European Union and other countries that have been blocking the waiver, a media release said.

The Biden administration’s decision will make it easier for the WTO’s General Council to approve the proposal.

https://www.cnbctv18.com/world/us-pharma-body-disappointed-over-decision-to-support-covid-19-vaccine-patent-waiver-9210601.htm

WHO experts voice 'very low confidence' in some Sinopharm COVID-19 vaccine data

 WHO experts have voiced "very low confidence" in data provided by Chinese state-owned drugmaker Sinopharm on its COVID-19 vaccine regarding the risk of serious side-effects in some patients, but overall confidence in its ability to prevent the disease, a document seen by Reuters shows.

A World Health Organization spokesman said that the document on Sinopharm vaccine BBIBP-CorV was "one of many resources" on which recommendations are made, tentatively scheduled to be issued later this week.

In Beijing, Sinopharm was not immediately reachable for comment outside working hours.

The "evidence assessment" document was prepared by the WHO's Strategic Advisory Group of Experts (SAGE) for its review scheduled this week of the Sinopharm shot, authorised by 45 countries and jurisdictions for use in adults, with 65 million doses administered. The experts review evidence and give recommendations on policy and dosages associated with a vaccine.

The document includes summaries of data from clinical trials in China, Bahrain, Egypt, Jordan and the United Arab Emirates.

Vaccine efficacy in multi-country Phase 3 clinical trials was 78.1 per cent after two doses, the document said. This was a slight drop from 79.34 per cent announced previously in China.

"We are very confident that two doses of BBIBP-CorV are efficacious in preventing PCR confirmed COVID19 in adults (18-59 years)," the document said.

But it added: "Analysis of safety amongst participants with comorbidities (was) limited by the low number of participants with comorbidities (other than obesity) in the Phase 3 trial."

Among "evidence gaps", it cited data on protection against severe disease, duration of protection, safety for use in pregnant women and in older adults and identification/evaluation of rare adverse events through post-authorisation safety monitoring.

"We have very low confidence in the quality of evidence that the risk of serious adverse events following one or two doses of BBIBP-CorV in older adults (≥60 years) is low," it said.

"We have very low confidence in the quality of evidence that the risk of serious adverse events in individuals with comorbidities or health states that increase risk for severe COVID-19 following one or two doses of BBIBP-CorV is low," it added.


The SAGE analysis was prepared as a WHO technical advisory group currently reviews the vaccine for an emergency use approval, which would not only pave the way for its use in the global COVAX vaccine sharing platform but also provide a crucial international endorsement for a vaccine developed in China.

A WHO spokesman said that a decision on the listing was not expected on Wednesday.

https://www.channelnewsasia.com/news/world/who-experts-voice-very-low-confidence-in-some-sinopharm-covid-19-14748910

BioNTech founder (UÄŸur Åžahin) live seminar at European Research Council

 https://www.youtube.com/watch?v=lq2iwBjwNso