21 Arrested In NJ Statewide COVID-Crisis-Related Child Porn Bust

A total of 21 people were busted in an undercover operation called “Operation Screen Capture” that targeted possible offenders who used the coronavirus lockdown as an opportunity to prey on children, the Office of Attorney General announced Wednesday.

The 21 arrested in the sting included 20 men and one woman, all from 10 New Jersey counties: Bergen, Burlington, Camden, Essex, Gloucester, Mercer, Monmouth, Middlesex, Ocean and Sussex.

The COVID-19 pandemic — which shut down schools and led to children spending more time than ever on their laptops, phones and gaming consoles — led to a marked increase in online predators sexually preying on children and teens, Attorney General Gurbir Grewal said.

In fact, March through July of this year saw as much as a 50 percent increase in tips to New Jersey’s Internet Crimes Against Children Task Force compared to the same time period in 2019, said Grewal. about:blank

That task force, monitored by the New Jersey State Police, receives tips from the National Center for Missing and Exploited Children, law enforcement agencies and other sources.

“It is no coincidence we reacted to an alarming increase; tips went up as much as 50 percent during COVID compared to the same time last year,” said Grewal. “There’s a simple explanation: During this pandemic, people are spending more time online. Homebound children were spending more time on their devices. But at the same time, predators were spending more time online, taking advantage of this situation.”

And Col. Patrick Callahan, head of the New Jersey State Police, said he is worried about the fall.

“With some school districts doing all-remote learning, it’s a concern for us,” said Callahan. “This pandemic has driven children to their electronic devices, and in doing so, we’ve increased the opportunity exponentially for these online predators. The increases we’ve seen since the pandemic began give us great concern.”

There is also a new age group being targeted: Police are noticing an alarming trend in children ages 7-9 making videos and sharing them on sites such as TikTok. Some of those young children are sought out by predators, who convince the children to create and upload sexually explicit videos.

“We are seeing these younger kids sharing videos that never shared videos before,” said one law enforcement officer.

Three of the most egregious cases involved an Oklahoma man who police say traveled to New Jersey hoping to meet underage teen girls for sex; a Keansburg man who police say convinced a 14-year-old Louisiana girl to carve his initials into her leg; and a Newark woman who police say performed a sexual act on a toddler she was babysitting and then broadcast a video of that on social media.

Others are accused of sharing child porn videos and photos, including, in many cases, child rape videos.

“These are heinous crimes,” said Grewal. “As children return to virtual learning this fall, they will be spending even more time online, in many cases without any in-person teacher supervision or peer contact. This may make them even more vulnerable. We want parents to be aware.”

The three most serious offenses in Operation Screen Capture are:

Aaron Craiger. Craiger, 34, of Oklahoma, a registered sex offender, was arrested March 18 at a motel in Atlantic City after he allegedly traveled from Oklahoma to meet two men who offered him access to underage girls for sex. In reality, he was talking with undercover investigators from the New Jersey State Police and U.S. Homeland Security. One investigator pretended to offer his 12-year-old daughter for sex, and the other, his girlfriend’s 11-year-old daughter. Craiger, who had condoms with him when arrested, also allegedly possessed and distributed child sex abuse materials.

“In early March as the coronavirus began to ravage New Jersey and the country, he traveled from his home in Oklahoma to New Jersey,” said Grewal.

Jason Berry. Berry, 40, of Keansburg, allegedly sexually exploited a 14-year-old Louisiana girl he met on Snapchat, manipulating her into sending him naked pictures of herself engaging in sex acts. He allegedly had the girl carve his initials into her legs. He then tricked the girl into revealing her mother’s phone number and sent those images to her mother.

“He exploited a vulnerable 14-year-old girl over a very short period of time, a few weeks, ” said the attorney general. “He groomed and manipulated her to send naked photos of herself in sexual acts, forced her to carve his initials into her legs and then convinced her to send those photos to her mother. He used SnapChat to meet his victim.”

Alize Tejada. Tejada, 21, of Newark allegedly sexually assaulted a very young child. She allegedly videotaped herself performing a sexual act on the child and posted the video on social media.

Here are all 21 people arrested in “Operation Screen Capture. Their ages range from 18 to 71 and they include a daycare worker and a firefighting instructor. They were all taken into police custody between March 18 and July 31:

Aaron Craiger, 34, of Oklahoma. Gas station attendant. Arrested March 18. Two Counts of Attempted Aggravated Sexual Assault (2nd degree), Distribution of Child Pornography (2nd degree), Possession of Child Pornography (3rd degree), Two Counts of Endangering the Welfare of a Child (3rd degree), Two Counts of Attempted Distribution of Marijuana (4th degree), Possession of Marijuana (Disorderly Persons Offense).

Jason Berry, 40, of Keansburg. Unemployed. Arrested June 18. Manufacturing Child Pornography (1st degree), Sexual Assault (2nd degree), Child Abuse (2nd degree), Distribution of Child Pornography (2nd degree), Theft by Extortion (2nd degree), Possession of Child Pornography (3rd degree).

Alize Tejada, 21, of Newark. Babysitter. Arrested July 15. Aggravated Sexual Assault (1st degree), Manufacturing Child Pornography (1st degree).

Michael Gilpin, 42, of Union Beach. Pipe fitter. Arrested July 26. Possession of Child Pornography (3rd degree).

Raymond Radziewicz, 53, of Bloomfield. Former teaching assistant at child care center who was terminated as a result of this arrest. Arrested July 7. Distribution of Child Pornography (2nd degree), Possession of Child Pornography (3rd degree).

Brett Warfield, 21, of Carney’s Point. Private security guard. Arrested July 15. Possession of Child Pornography (3rd degree).

Loic Atse, 18, of Aberdeen. College student. Arrested July 23. Possession of Child Pornography (3rd degree).

Donovan Falconer, 25, of Plainsboro. Employee of marketing firm. Arrested June 25. Distribution of Child Pornography (2nd degree), Possession of Child Pornography (3rd degree).

Michael Ascough, 39, Pompton. Retail employee. Arrested July 5. Distribution of Child Pornography (2nd degree), Possession of Child Pornography (3rd degree).

Joseph Benestante, 65, of Bergenfield. Retired. Arrested July 21. Distribution of Child Pornography (2nd degree).

Shawn Daily, 45, of Browns Mills. Laborer. Arrested June 12. Possession of Child Pornography (3rd degree).

Roy Dantz, 71, of Mount Laurel. Retired. Arrested June 18. Possession of Child Pornography (3rd degree).

Christopher Crispino, 45, of Bellmawr. Unemployed. Arrested July 31. Possession of Child Pornography (3rd degree).

Dwayne McCormick, 25, of Orange. Unemployed. Arrested July 8. Distribution of Child Pornography (2nd degree), Possession of Child Pornography (3rd degree).

Juvenile Male, 15, of Gloucester County. Unemployed. Arrested July 22. Distribution of Child Pornography (2nd degree), Possession of Child Pornography (3rd degree).

Julian Ceballos, 31, of Hamilton (Mercer County). Restaurant worker. Arrested June 26. Possession of Child Pornography (3rd degree).

Timothy McMahon, 46, of Piscataway. Electrician. Arrested May 21. Possession of Child Pornography (3rd degree).

Edward Kross, 66, of Carteret. Part-time firefighting instructor. Arrested May 28. Possession of Child Pornography (3rd degree).

Henry Ziolkowski, 66, of Toms River. Surgery technician. Arrested July 10. Possession of Child Pornography (3rd degree).

Kevin Carrierri, 34, of Toms River. Chef. Arrested July 10. Possession of Child Pornography (3rd degree).

Matthew Marzullo, 20, of Hopatcong. Restaurant food server. Arrested July 1. Possession of Child Pornography (3rd degree).

Adults can find and groom children on apps such as Kik, Skout, Grindr, Whisper, Omegle, Tinder, Chat Avenue, Chat Roulette, Wishbone, Live.ly, Musical.ly, Paltalk, Yubo, Hot or Not, Down and Tumblr.

Arrests have also been made involving the gaming apps Fortnite, Minecraft and Discord.

“It used to be that kids would play outside, and parents would check on them every so often to make sure they were safe,” said Burlington County Prosecutor Scott Coffina. “But the dangers they face have become much more direct now that they are spending a greater amount of time online than they ever have before.”

Want to keep your child safe? Here are 5 things parents can do right now:

• Teach your children that the people they encounter online or on their phones may not be who they seem. “Your 13-year-old may think they are talking to another 13-year-old on a video game app. In reality, they are not,” said a State Police officer.

• Familiarize yourself with all the popular apps and gaming platforms, such as SnapChat, TikTok and Fortnite, just to name to a few. Know what games and apps your kids are using online.
• Check the security settings on your kids’ phones and games. Who are your kids chatting with? Can they only talk to friends and family, or are their settings open to the public?
• Constantly remind your children not to share personal information with strangers on the Internet, or use a screen name that reveals their age or gender, such as SweetSixteen, FortniteFan9 or FashionGirl12. Tell kids they should never take sexual photos of themselves and share them online.
• Be wary if your child is secretive or protective about their phone. Never let them take their phone into their bedroom alone at night. Establish a family phone charging station and all phones must be docked there at night — not in the child’s bedroom.

“You may think nothing can happen with your children home all day,” said Veronica Allende, director of the New Jersey Division of Criminal Justice. “But notice if your children’s behavior changes with their devices and when sending text messages. Are they secretive, withdrawn, angry and depressed?”

If you suspect a child is talking to a predator online, the National Center for Missing and Exploited Children hotline number is (800) 843-5678 or online at report.cybertip.org.

https://patch.com/new-jersey/woodbridge/amp/28927243/21-arrested-in-nj-statewide-covid-crisis-related-child-porn-bust

Sleeping Through a Pandemic

More than half the people surveyed in an online population study experienced serious sleep difficulties during the COVID-19 pandemic, but certain individuals reported better sleep.

While there was high variability in sleep changes, three distinct profiles of sleep-related behaviors emerged during the pandemic, reported Rebecca Robillard, PhD, of the University of Ottawa and the Royal’s Institute of Mental Health Research in Canada, at the virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society.

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More than half the people surveyed in an online population study experienced serious sleep difficulties during the COVID-19 pandemic, but certain individuals reported better sleep.

While there was high variability in sleep changes, three distinct profiles of sleep-related behaviors emerged during the pandemic, reported Rebecca Robillard, PhD, of the University of Ottawa and the Royal’s Institute of Mental Health Research in Canada, at the virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society. https://tpc.googlesyndication.com/safeframe/1-0-37/html/container.html

“Our results suggest that the effects of the pandemic on sleep are more complex than just bad or good,” Robillard observed.

“The pandemic involves a global external stressor with widespread consequences and for many, this leads to some degree of psychological distress, a phenomenon well known to interact with sleep,” she said.

It also caused major changes in daily routines. “For some, confinement may lift off certain constraints — for example, for those working from home — while for others this might bring new challenges — for example, increased family duties which may cause longer days and shorter nights,” Robillard noted.

“From this perspective, the pandemic may bring people to change some of their sleep behaviors, such as the time at which they go to bed, wake up, and the overall time that they spend in bed. And these behavioral changes may also affect broader sleep outcomes like sleep quality, duration, the degree of social jet lag, and the frequency and severity of sleep difficulties.”

n their study, Robillard and colleagues surveyed 5,525 Canadians, ages 16 to 95, from April 3 to June 24. Respondents had an average age of 55; 67% were female, 88% were white, and 64% had underage children. Shift workers and people who had traveled to another time zone in the past 30 days were excluded. Questionnaires asked about sleep patterns and mental health both during and before the pandemic.

The overall rate of any serious sleep difficulties — including initiating sleep, maintaining sleep, or waking too early — rose from 36% before the pandemic to 51% during it. “We also observed that 8% of our sample reported an increase in the frequency of sleeping medication used during the outbreak,” Robillard said.

Zooming in on specific data points, the story was less clear. There was no overall significant change in Pittsburgh Sleep Quality Index (PSQI) scores, but 5.8% of respondents showed minimally clinically important improvement on the PSQI during the pandemic and 17.5% had minimally clinically important worsening.

Cluster analysis showed three pandemic sleep patterns:

• Extended time in bed, characterized by later wake-up times
• Reduced time in bed, characterized by later bedtimes and earlier wake-up times
• Phase delay, characterized by later bedtimes and wake-up times, with a small lengthening of time in bed

People in each profile group had different changes in sleep outcomes during COVID-19. While the extended time in bed group showed no major changes in sleep, the reduced time in bed group lost more than 1 hour of sleep on average. The phase-delay group had a significant lengthening of sleep latency and a reversal of their social jet lag (calculated as the difference between preferred and actual sleep schedules) during the pandemic. “While before the outbreak, they had earlier sleep schedules than their preferred times, during the outbreak they now had even later sleep schedules than their preferred times,” Robillard said.

The highest rates of sleep initiation difficulties occurred in the phase-delay group. The highest rates of worsening in sleep maintenance and early morning awakenings were seen in the reduced time in bed group.

The three groups also had different psychological responses to the pandemic. Compared with the extended time in bed group, the reduced time in bed and phase-delay groups had higher rates of worsening in stress, anxiety, and depressive symptoms. These two groups also had more women, people diagnosed with mental disorders, and evening chronotypes.

Overall, new sleep difficulties during the pandemic were linked with being female, being employed, having family responsibilities, waking up earlier, chronic illnesses, higher stress levels, heavy drinking, and heavy television exposure. “Altogether, these factors may give rise to some insights to identify the people and the behaviors more at risk for adverse sleep outcomes in response to the pandemic,” Robillard noted.

Limitations of the study include possible recall bias. “The findings highlight the need for tailored sleep interventions to address the distinct profiles of sleep problems that have emerged during this pandemic,” Robillard said. “While some of these sleep problems may be transient for some people, it should be a high priority to ensure that they do not crystallize in chronic sleep disorders.”

Disclosures

Robillard disclosed no relevant relationships with industry.

Primary Source

SLEEP

Source Reference: Robillard R, et al “The COVID-19 Pandemic and Sleep Changes in the General Population” SLEEP 2020.

https://www.medpagetoday.com/meetingcoverage/apss/88355

AstraZeneca: diabetes drug improves survival in kidney disease

AstraZeneca said its Farxiga drug improved survival chances for patients suffering from kidney disease, underscoring the medicine’s role outside its established field of diabetes.

The British drugmaker said Farxiga was shown in a study to cut the risk of dying from any cause for people suffering from chronic kidney disease by 31% when compared to a group on placebo.

Farxiga is among AstaZeneca’s five best-selling drugs and brought in revenues of $1.54 billion in 2019 for treating diabetes. It also reduced the risk of deteriorating kidney function by 39% in the trial.

Chronic kidney disease (CKD) is a serious, progressive condition which affects nearly 700 million people worldwide, and has limited treatment options. It can progress to kidney failure and leave patients requiring dialysis.

The company aims to request regulatory approval for expanded use of the drug in chronic kidney disease over the next few months, said Mene Pangalos, the head of Astra’s biopharmaceuticals research and development.

Farxiga, like other drugs in the so-called class of SGLT2 inhibitors, helps type-2 diabetics by prompting the kidneys to expel excess blood glucose through the urine.

But it has been shown to have a separate beneficial effect on the heart and the kidneys not related to blood sugar control. That mode of action, though not fully understood, is believed to protect structures in the kidneys that filter blood.

Astra released a brief statement on the trial’s success in July, holding back details that are presented at the annual European Society of Cardiology congress over the weekend.

Astra is ahead of other makers of SGLT2 inhibitors – Eli Lilly and partner Boehringer Ingelheim with their drug Jardiance, and Johnson & Johnson with Invokana – in widening the drugs’ use beyond diabetes.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-diabetes-drug-improves-survival-in-kidney-disease-patients-study-shows-31204079/

FDA commissioner says willing to fast-track COVID-19 vaccine

The head of the U.S. Food and Drug Administration (FDA) is willing to fast-track a COVID-19 vaccine as quickly as possible, the Financial Times reported him as saying in an interview published on Sunday.

Dr. Stephen Hahn, the FDA Commissioner, said his agency was prepared to authorize a vaccine before Phase Three clinical trials were complete, as long as officials are convinced that the benefits outweigh the risks, the newspaper reported https://on.ft.com/3b8Uq8I.

Without providing evidence, U.S. President Donald Trump last Saturday accused members of a so-called “deep state” working within the FDA of complicating efforts to test COVID-19 vaccines in order to delay results until after the Nov. 3 presidential election.

A day later, the FDA gave “emergency use authorization” of a coronavirus treatment that uses blood plasma from recovered patients.

“Our emergency use authorization is not the same as a full approval,” Hahn told the FT, adding that his decisions will not be made because of political pressure.

“This is going to be a science, medicine, data decision. This is not going to be a political decision,” Hahn said, according to the report.

He said the safest way for the vaccine to be available for use before the end of Phase Three trials, which involve thousands of patients and can take years, would be by issuing an emergency authorization for use by certain groups rather than a blanket approval, the FT reported.

https://www.marketscreener.com/news/FDA-commissioner-says-willing-to-fast-track-COVID-19-vaccine-FT–31204031/?countview=0

How U.S. could release Covid vaccine before election, and why that scares some

When President Donald Trump accepted his party’s nomination for another term last night at the Republican National Convention, he pledged that the push by his administration’s Operation Warp Speed to deliver a COVID-19 vaccine would succeed “before the end of the year, or maybe even sooner.”

That promise concerns many vaccine veterans. They worry that political forces—the U.S. presidential election on 3 November, nationalistic pride to “win” a race, the need to resuscitate economies—could lead to premature and dangerous approvals under mechanisms such as the emergency use authorization (EUA), a pathway used by the U.S. Food and Drug Administration (FDA) to allow rapid access to diagnostics, treatments,  and vaccines. Long a bastion of regulatory rigor that many other countries look to for guidance, FDA has been criticized for issuing EUAs for two COVID-19 treatments, convalescent plasma and hydroxychloroquine, based on scant data and apparent political pressure. (The hydroxychloroquine EUA has since been revoked.) Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia who is a member of a group that advises FDA about its vaccine decisions, suspects the Trump administration might seek a COVID-19 vaccine EUA before the elections and say: “We Warp Speeded our way to a vaccine.”

China and Russia already have approved limited use of COVID-19 vaccines outside of clinical trials, offering baffling—and sharply criticized—rationales. In the United States, Operation Warp Speed, as its name implies, hopes to move vaccine candidates forward more quickly than ever before. It has invested more than $10 billion in developing eight different COVID-19 vaccines, with much of that money pre-purchasing hundreds of millions of doses so they will be at the ready if an FDA approval comes through. Three of the Warp Speed-backed vaccines have entered efficacy trials, and one manufacturer has pledged to start delivering the first of 300 million doses as early as October—though one person close to Operation Warp Speed says, “There won’t be enough vaccine in October to create anything other than a news story.”

FDA officials have insisted they have “unwavering regulatory safeguards” and will not cut any corners. “The acceleration is really around taking financial risk [with regard to] the development process,” FDA Commissioner Stephen Hahn said at a U.S. House of Representatives committee hearing about the country’s COVID-19 response in June. “We will rely upon data and science when it comes to that decision about an EUA.”

Peter Marks, who runs the FDA division that oversees vaccine approval, has vowed that he would resign if the Trump administration pushed through a vaccine that was not clearly safe and effective. And he insists that FDA will consult with the Vaccine and Related Biological Products Advisory Committee (VRBPAC), which Offit sits on, to publicly discuss data related to any approval request. “Approval should be something that we can make transparent, and to do anything less than that is really a disservice to people,” Marks says. VRBPAC’s next meeting is scheduled for 22 October, 12 days before the presidential and congressional elections.

Science spoke with a range of researchers and regulators about how a COVID-19 vaccine approval might be accelerated and the potential consequences.

What’s the traditional vaccine approval pathway?

After initial laboratory and animal tests, vaccines enter phase I human trials that typically have about 20 to 100 people and primarily analyze safety and immune responses. Phase II studies are larger versions of phase I trials. Phase III studies attempt to determine whether a vaccine works by comparing people who receive it with those who are given a placebo shot and, over several months or years, seeing how many in each group get infected. For COVID-19 vaccines these trials involve anywhere from 10,000 to 60,000 people and will need a total of about 150 cases of disease to determine whether a candidate works. Once the trial endpoints are met, a vaccine developer seeking FDA approval would file a biologics license application; VRBPAC would review the data at a public meeting, then vote on whether the vaccine should receive approval—a recommendation FDA normally follows. The approval process, which involves inspecting the vaccine’s manufacturing plants, can often take 1 year.

How does an EUA work?

An EUA in the United States, and similar regulatory pathways in many countries, allows use of an unlicensed vaccine outside of a clinical trial. The EUA could stipulate the use of the vaccine in a limited population, for example, health care workers or the elderly. Or it could be for the general population. An EUA offers liability protections to vaccinemakers, and it remains in effect as long as there is a public health, military, or national security emergency. When the emergency ends, so does the approval.

What safety and efficacy evidence would FDA require before issuing an EUA?

FDA issued a “guidance for industry” in June that says any emergency decision on a COVID-19 vaccine would be based on factors such as “the target population, the characteristics of the product, [and] the preclinical and human clinical study data.” The guidance specifies that FDA will only approve an EUA for a vaccine that has at least 50% efficacy. But estimates of efficacy have error bars of sorts; for a COVID-19 vaccine, FDA wants 95% confidence that efficacy is no lower than 30%. The decision to consider an EUA request would likely be based on data reviewed by the independent boards, set up by the vaccine’s sponsors or clinical trial investigators, that monitor safety and efficacy during the study.

What harm could an EUA do?

Public Citizen, a public advocacy group, has argued that regardless of whether a COVID-19 vaccine is effective, an EUA could fuel existing vaccine hesitancy. “The ‘logic’ of saving several months by a faster but riskier EUA pathway will surely be outweighed by the loss in public confidence in the vaccine, accompanied by decreased willingness to be vaccinated,” Public Citizen warned in a 6 August letter to Marks and his superiors. An EUA for a vaccine might also make it more difficult to recruit people for clinical trials of that vaccine and others, because participants might not want to take the risk of receiving a placebo when they can get a shot of a product that’s authorized for use.

What if the vaccine doesn’t work well or causes harm?

Vaccines go into healthy people, so putting them into use before fully assessing their risks and benefits is a bigger gamble than issuing an EUA for an experimental treatment for someone already ill. If a hastily approved COVID-19 vaccine candidate proves ineffective or has serious side effects, confidence in what many see as the best hope to ending the pandemic could plummet. The Solidarity Vaccines Trials Expert Group of the World Health Organization (WHO) argued in an editorial published in The Lancet yesterday that a weakly effective vaccine could actually worsen the pandemic if it induced authorities to relax control measures, such as mask wearing, or if vaccinated people believed they were immune and increased their risk-taking behavior.

Has an EUA ever been used for a vaccine?

Yes. In 2005 FDA granted an EUA for an anthrax vaccine for people who the military determined were at high risk of attack from anthrax used as a biological weapon. The episode provoked lawsuits claiming there was no evidence that the vaccine, which the military required soldiers to get, worked against the type of inhalational anthrax used in bioweapons. A judge ruled in favor of the plaintiffs, but by then the vaccine had become voluntary.

What’s the difference between FDA’s expanded access program and an EUA?

Typically expanded access, also called compassionate use, covers treatments, not vaccines, in the United States. It’s for individuals who have a life-threatening condition and no alternatives or for small groups of sick people when a treatment has promising evidence but efficacy has not been proven yet. Anyone who receives the experimental medicine signs an informed consent form, and institutions that provide it have to seek permission from FDA, submit a protocol, report adverse events, and do continued safety monitoring. An EUA eliminates these requirements. FDA allowed nearly 100,000 people to receive convalescent plasma through expanded access—an unusually large instance of compassionate use—but last week granted an EUA that proponents said would cut paperwork. The Democratic Republic of the Congo used its own expanded access regulation to allow more than 300,000 people to use an unlicensed Ebola vaccine.

Does Europe have a similar emergency approval process?

The European Medicines Agency (EMA) can issue “conditional approval” for a vaccine during a pandemic. Under a rolling-review process, companies continue submitting data as they becomes available. The United Kingdom, which will be leaving the EMA’s authority because of Brexit, today issued a consultation for public comment on how its regulatory agency might issue its own temporary authorization of an unlicensed COVID-19 vaccine.

How did China and Russia speed approval of their COVID-19 vaccines?

China on 25 June gave CanSino a 1-year approval to use its COVID-19 vaccine in the Chinese military, although there is no evidence beyond statements by company officials that anyone has received it. On 22 July, China also allowed Sinopharm’s China National Biotec Group Company to give its COVID-19 vaccine to health care workers, customs workers, and others in “high-risk” professions. Both vaccines are still in phase III efficacy trials. CanSino also reportedly is in discussion with regulators in Pakistan and unnamed Latin American countries about early approval of its vaccine.

Russia’s Gamaleya Research Institute of Epidemiology and Microbiology in Moscow on 11 August received a “registration certificate” to give a COVID-19 vaccine to what a Ministry of Health spokesperson described as “a small number of citizens from vulnerable groups,” including medical staff and the elderly. Dubbed Sputnik V, a clear reference to the U.S.-Soviet space race, the product is billed as “the first registered COVID-19 vaccine.” The registration says it cannot be used widely until after 1 January 2021, but President Vladimir Putin said, “I hope we can start a massive release of this vaccine soon.”

Many countries do not have strong regulatory agencies. How do they decide whether to use a COVID-19 vaccine that is not licensed?

WHO has what it calls an Emergency Use Listing, which many low- and middle-income countries have relied on in the past. “We can give a benefit/risk decision on a product and specify the conditions under which it should be used,” says Emer Cooke, director of WHO’s Regulation of Medicines and other Health Technologies. “We act like a regulatory body, but we’re not a regulatory body.” Cooke, who recently was elected to head EMA later this year, says their job is especially complex now because of the flood of COVID-19 vaccine candidates and the intense pressure to find one that is safe and effective. “I think we are seeing more political influences now than we would normally see,” she says.

https://www.sciencemag.org/news/2020/08/here-s-how-us-could-release-covid-19-vaccine-election-and-why-scares-some#