WHO Panel Authorizes Emergency Use of China’s Sinopharm Vaccine

The World Health Organization gave emergency use authorization Friday to a COVID-19 vaccine manufactured by China's Sinopharm

WHO Panel Authorizes Emergency Use of China’s Sinopharm Vaccine

(GENEVA) — The World Health Organization gave emergency use authorization Friday to a COVID-19 vaccine manufactured by China’s Sinopharm, potentially paving the way for millions of the doses to reach needy countries through a U.N.-backed program rolling out coronavirus vaccines.

The decision by a WHO technical advisory group, a first for a Chinese vaccine, opens the possibility that Sinopharm’s offering could be included in the U.N.-backed COVAX program in coming weeks or months and distributed through U.N. children’s agency UNICEF and WHO’s Americas regional office.

Aside from efficacy numbers, the Chinese manufacturer has released very little public data about its two vaccines – one developed by its Beijing Institute of Biological Products and the other by the Wuhan Institute of Biological Products.

The Beijing shot is one the WHO advisory group considered for the emergency use listing.

“This afternoon, WHO gave emergency use listing to sign off on Beijing’s COVID-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality,” WHO Director-General Tedros Adhahom Ghebreysus said.

.The Sinopharm vaccine will join ones made by Pfizer-BioNTech, Johnson & Johnson, Moderna, AstraZeneca, and a version of the AstraZeneca vaccine made by the Serum Institute of India, in receiving the coveted authorization from the U.N. health agency.

“This expands the list of vaccines that COVAX can buy and gives countries confidence to expedite their own regulatory approval and to import and administer a vaccine,” Tedros said at a Geneva news conference.

Previously, a separate group advising WHO on vaccines said it was “very confident” the Sinopharm vaccine protects people ages 18-59. The group said it had a “low level of confidence” in the vaccine’s efficacy for people 60 and over. Its members said they had “very low confidence” in the available data about serious side effects in that age group.

Sinopharm hasn’t published its late-stage test results in scientific journals, so the WHO requested a breakdown of its data, which come mostly from the United Arab Emirates. A summary posted online by WHO suggests the vaccine is about 78% effective, with the caveat that all but a few hundred of the study volunteers were younger than 60.

Gavi, the Vaccine Alliance, which co-runs COVAX, welcomed the announcement.

“This means the world has yet another safe and effective tool in the fight against this pandemic,” the alliance said. The public-private partnership said it was in discussions with several manufacturers, including Sinopharm, “to expand and diversify the portfolio further and secure access to additional doses” for countries in the COVAX program.

COVAX aims to send vaccines for free to 92 lower-income countries and to help another 99 countries and territories procure them. It was not immediately clear when the Chinese vaccine might be made available to the COVAX portfolio

The program, which has already distributed over 54 million doses of COVID-19 vaccines but faces limited supplies from Western countries and India, has been working hard to strike deals as part of its goal to procure 2 billion doses by the end of the year.

Suerie Moon, co-director of the Global Health Program at Geneva’s Graduate Institute, said the WHO decision on the Sinopharm COVID-19 vaccine and other Chinese vaccines will “carry a lot of weight” because of limited information publicly available about them.

“The decision is also sure to be scrutinized all around for any whiff of political bias, and no doubt the committee members were very well aware of this,” she said, noting that the decision could also be a boon for developing countries in need of coronavirus vaccines.

“If there is a greenlight, these vaccines could boost the thin stream of supplies that has been channeled through COVAX to date,” she said, as the program has been hit hard by export bans limiting vaccine supply from India. India has kept those doses amid a surge of cases at home.

Moon also said if Chinese suppliers start channeling large volumes, “this would signal a step-change in their participation in global vaccine markets.” Before the pandemic, India was a well-integrated player in the global health vaccine supply system, but China was not, she said.

WHO’s decision on Sinopharm, months in the making, was particularly complex because the vaccine has not faced the high-level scrutiny of a rigorous medicines regulator like those in Europe and the U.S.

The WHO panel relied frequently on those Western agencies’ findings when it came to vaccines that it has already approved emergency use.

Many officials in countries without such regulatory structures rely on WHO’s emergency use listings to authorize vaccine rollouts for their populations.

Hundreds of millions of Chinese vaccines have already been delivered to dozens of countries around the world through bilateral deals as many scrambled to secure supplies after rich countries had reserved the vast majority of supplies from Western pharmaceutical makers.

While China has five shots in use, the majority of its exports abroad come from two companies: Sinopharm and Sinovac. A decision on Sinovac is expected next week, WHO said.

The Chinese vaccines are “inactivated” vaccines, made with killed coronavirus. Most other COVID-19 vaccines being used around the world, particularly in the West, are made with newer technologies that instead target the “spike” protein that coats the surface of the coronavirus.

Sinopharm said last month that over 100 million doses of its two vaccines have been used across the world.

Sinovac, by comparison, has shared relatively more data. Last month, a study published by a team of scientists in Brazil confirmed a previously reported efficacy rate of over 50%. A real-world study in Chile also last month found an efficacy rate of 67%.

___

Huizhong Wu in Taipei, Taiwan, and AP Medical Writers Lauran Neergaard in Washington and Maria Cheng in London contributed to this report.

Source : Time More   

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‘Needle Phobia’ May Be Keeping Some From Getting Their COVID-19 Vaccine. Here’s How to Cope

'I'm not a child, I'm acting like an adult with a phobia'

‘Needle Phobia’ May Be Keeping Some From Getting Their COVID-19 Vaccine. Here’s How to Cope

Alex Denley, a 23-year-old philosophy doctoral student at the University of Illinois at Chicago, doesn’t seem like someone who would be vaccine hesitant. They’re determined to stop COVID-19 from spreading, and haven’t fallen for any vaccine conspiracy theories. However, getting the coronavirus shot was tremendously stressful for Denley. They feared it could trigger a terrible panic attack, leaving them crumpled on the floor, sobbing and shaking in front of a crowd of onlookers. They were also worried about health care providers dismissing their fears.

“I don’t want to be treated like a child because I have a phobia. I’m not a child, I’m acting like an adult with a phobia,” says Denley. “I don’t believe that vaccines are particularly painful…It’s literally just that for some reason, my brain processes this in a way that is really intense and unexpected.”

Denley struggles with “blood injection injury phobia,” also known as needle phobia. Since they were a child, they’ve experienced debilitating fear when receiving injections. According to studies (also see here, here and here) conducted in different countries, as many as one in four adults have some fear of needles, causing symptoms from butterflies in their stomach to debilitating panic attacks—and one in 10 are so fearful that they refuse vaccination entirely, says Meghan McMurtry, an associate professor of clinical psychology at the University of Guelph in Ontario, Canada.

Needle phobia has long been a public health issue. Sixteen percent of adults avoid flu shots at least partly because they’re afraid of needles, according to a 2019 meta-analysis across multiple countries published in the Journal of Advanced Nursing. But it’s especially salient now, as public health officials strive to vaccinate as many people as possible against COVID-19. Someone who is even mildly nervous about injections may be less likely to get their coronavirus shot—a February study published in the journal Vaccine found that among people who said they were unlikely to get or unsure about getting the COVID-19 vaccine, 12% said that they are afraid of or hate needles.

To help the needle-phobic, McMurtry says that vaccination sites should let people know ahead of time which questions they’ll be asked and what accommodations can be made for them. The site itself should be calm and organized, and people shouldn’t be made to wait on long lines, which could trigger anxiety. Finally, recipients should be vaccinated privately so they don’t have to worry about having an audience.

When administering the shot, providers should encourage patients to do whatever helps them handle the process, McMurtry says. Some may want to watch the needle while others want to turn away, for instance. Distractions like listening to music or using a phone can also be helpful. Providers shouldn’t use language that implies pain, like “here comes the pinch!,” as the shot may hurt more if someone is very tense. However, they also shouldn’t minimize the fact that the shot could hurt.

“You say things like, ‘some people say it pinches for a few short seconds, other people say it doesn’t bother them, but you can tell me what it was like for you afterwards,'” McMurtry says. “So you are basically opening up a space for them to have their own kind of experience.”

For needle phobic people, McMurtry suggests sticking to a plan to guide yourself through the process. Make sure you know how to get to your vaccination site, what you’ll wear the day of your appointment, and how to distract yourself when you’re getting the injection. If possible, get a friend to help plan your appointment, or bring one along on the day of your shot. You can also talk to a doctor about topical anesthetics, which can numb the injection area. People who tend to faint when getting an injection can use muscle tensing practices to keep their blood pressure up. In some cases, exposure therapy—in which phobia sufferers willingly and gradually increase their exposure to their trigger—can work, too.

Friends and family can also help loved ones cope with needle phobia, McMurtry says. Most of all, avoid making anyone feel guilty about their fears—instead, acknowledge that a person’s “fear is real,” and that it’s “not something they should just get over,” she says. When describing their own vaccination experiences, they should avoid talking about the negatives, but rather focus on the positive or neutral parts.

Denley, for one, found it helpful to speak with health care providers about their concerns before their appointment; they were prescribed an anti-anxiety medication and a topical cream. Denley had nightmares leading up to their appointments and repeatedly thought about canceling their Uber to the vaccination site. Nevertheless, they managed to overcome their fear and received both doses of the Pfizer-BioNTech vaccine.

What was particularly helpful, Denley says, was the kindness of a provider who administered the first shot. That kind of understanding attitude may be key to helping the needle phobic among us protect themselves from COVID-19. “Being kind of dismissive or joking about needle fear is likely not helpful…It can feel very invalidating for the individual, and it’s not going to really solve it,” says McMurtry. “We need to support each other through this.”

Source : Time More   

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