Ohio daycare providers ask to be vaccinated at same time as K-12 teachers

 When it comes to the coronavirus and vaccinations, local daycare workers are lobbying Ohio Governor Mike DeWine, saying they should be on the list.

The early childhood educators want to be considered a priority, allowing them to be vaccinated in February like teachers K-12.

Katie Theobold is an Early Childhood Education Director at Temple Emanu El in Orange Village.

“We don’t want to skip the line; we want to be treated like all educators that take care of children,” Theobold said.

At one point, early childhood educators were considered some of the heroes or essential workers during this COVID-19 pandemic.

That’s because the child care providers worked to ensure parents could work and take care of their families during this global health crisis.

“With the rollout that Governor DeWine issued, we were all under the impression that all educators would be listed in that category. And unfortunately, the criteria is only for K thru 12 teachers to actually get the vaccine starting in February,” Theobold said.

Theobold tells 19 News that so far, daycare workers are not on the list, and have no indication when they will be vaccinated.

“We are working with frontline families, we are working with doctors, we are working with nurses. We’re also working with teachers in a K through 12 programs. So until we are able to be vaccinated, anytime that we have to close our classrooms or buildings for quarantine that impacts the greater community,” Theobold said.

Daycares have had some issues with the virus, according to Theobold, but this isn’t just about the staff, but families as well.

“If we would have to close one of our classrooms down that would essentially mean, the child, that family would have to remain home or seven to twelve days,” Theobold tells 19 News.

There is now an online petition on Change.org, where families and others are supporting daycare workers with 9,000 signatures so far.

Theobold says they’ve taken a number of steps to safeguard daycares. They’ve also sent a letter to Governor Mike DeWine reminding him that the only way to ensure a program is safe is to have the staff vaccinated.

https://www.cleveland19.com/2021/01/25/daycare-providers-asking-gov-mike-dewine-allow-them-be-vaccinated-same-time-k-teachers/

Dexamethasone 'should still work' on new UK COVID variant

 A cheap steroid drug that can help save the lives of patients with COVID-19 should work on patients infected with the new more infectious variant of the coronavirus found in Britain, a senior medical official in England said on Monday.

Dexamethasone, a generic drug used since the 1960s to reduce inflammation in diseases such as arthritis, has been found to cut death rates among the most severely ill coronavirus patients admitted to hospital.

“We would expect Dexamethasone to work perfectly because this is about reducing your own immune response and calming that down so that your body can get over this virus,” Susan Hopkins, senior medical adviser at Public Health England told a press conference. “We would expect Dexamethasone will still be effective in reducing mortality with this virus.”

https://www.reuters.com/article/us-health-coronavirus-britain-dexamethas/steroid-should-still-work-on-new-covid-variant-english-medical-official-idUSKBN29U23C

Russia to supply Mexico with 24M COVID-19 vax doses: president

 Russia will supply Mexico with 24 million doses of the Sputnik V COVID-19 vaccine over the next two months, Mexican President Andres Manuel Lopez Obrador said after a phone call on Monday with Russian counterpart Vladimir Putin.

Putin’s pledge marks a sharp increase from a previous target from last week of 7.4 million doses through March, though some doubts over Russia’s production capacity persist.

Russia’s vaccine diplomacy has developed goodwill in Latin America after other pharmaceutical companies including U.S.-based Pfizer Inc announced shortfalls in distribution plans.

Lopez Obrador held the call with Putin despite announcing on Sunday that he was himself infected with COVID-19 and was being treated for mild symptoms.

The Mexican leader added in a post on Twitter that he had invited the Russian head of state to visit Mexico.

Lopez Obrador and Putin also discussed training for Mexican medical specialists in Russia, according to a news release from the Russian government.

Mexico has warned about a lack of doctors to accommodate the country’s high infection rate throughout the pandemic, particularly medical specialists. The country has among the lowest number of medical personnel relative to population among countries in the Organization for Economic Cooperation and Development, the government has said.

During the first three months of this year, tens of millions of doses are expected in Mexico from the Gamaleya Center, Sputnik V’s developer, as well as China’s CanSino Biologics Inc, Britain’s AstraZeneca and Pfizer.

But with Monday’s announcement, Sputnik V would be by far Mexico’s most-used vaccine over that time, in part because Pfizer cut back on what it had originally committed to Mexico.

Mexico’s health regulator has not yet approved Sputnik V, despite promising a quick process after a senior health official received clinical data during a visit to Argentina.

Argentina has spearheaded Sputnik V’s arrival in Latin America, adopting the vaccine early and administering hundreds of thousands of doses since late last year.

Global vaccine bottlenecks have been exacerbated by many wealthier nations refusal to participate in COVAX, a global vaccine program co-led by the World Health Organization.

The global body seeks to deliver at least 2 billion COVID-19 doses worldwide this year, with at least 1.3 billion for poorer countries.

But it has so far struggled to secure enough shots due to a shortage of funds, while richer countries have booked large volumes of vaccines for themselves.

https://www.reuters.com/article/us-health-coronavirus-mexico-russia/russia-to-supply-mexico-with-24-million-covid-19-vaccines-president-says-idUSKBN29U1T3

China says customs should prioritise inspection for COVID-19 vaccine exports

 China said on Tuesday that its customs department should prioritise procedures for exports of COVID-19 vaccines and make their clearance convenient.

Sinovac Biotech’s CoronaVac vaccine are being shipped to Indonesia, Turkey and Brazil for mass inoculation drives, while countries including Egypt and United Arab Emirates have received doses from China National Pharmaceutical Group (Sinopharm).

Customs should prioritise inspection procedures for carriers handling COVID-19 vaccine exports and make it convenient to clear shipments, China’s transport ministry said in a guideline about COVID-19 vaccine logistics.

Local transport authorities in China should also set up green channels to prioritise clearing vaccine shipment, the guideline said.

https://www.reuters.com/article/us-health-coronavirus-vaccine-china/china-says-customs-should-prioritise-inspection-for-covid-19-vaccine-exports-idUSKBN29V0C8

China says COVID-19 outbreaks will not lead to industrial shutdowns in north

 COVID-19 outbreaks in northern China will have some impact on industries but will not lead to manufacturing shutdowns, said Huang Libin, an official at the Ministry of Industry and Information Technology, at a media briefing on Tuesday.

https://www.reuters.com/article/us-china-economy-industry/china-says-covid-19-outbreaks-will-not-lead-to-industrial-shutdowns-in-north-idUSKBN29V09T

Gilead says Veklury should work against COVID-19 variants

 Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the UK and South Africa.

According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible shouldn’t affect the way Veklury (remdesivir) works.

The UK strain – known as  B.1.1.7 or VOC 202012/01 – has already been reported in dozens of countries around the world and is estimated to be somewhere between 50% and 70% more infectious than the original strain of SARS-CoV-2.

Last week, the Centers for Disease Control and Prevention (CDC) warned of rapid growth of the variant in coming weeks and said it could become the dominant strain in the US within weeks.

The South African variant B.1.351 (also known as 501Y.V2) meanwhile is also spreading around the world and is estimated to be 50% more transmissible.

So far, neither variant seems to be associated with more severe COVID-19 symptoms, although there has been some preliminary research suggesting the SA strain could allow reinfection with SARS-CoV-2, and also be less susceptible to vaccines. This week, Pfizer and BioNTech said their Comirnaty shot seemed to retain efficacy against the UK variant.

“The mutations identified in these new variants have not significantly altered the part of the virus that remdesivir targets or have any association with known mutations conferring reduced susceptibility of coronaviruses to remdesivir in vitro,” said Gilead in its statement.

“We continue to conduct additional research to evaluate newly emerging variants and to further understand their potential impact on remdesivir,” it added.

Veklury is currently the only antiviral drug licensed for the treatment of COVID-19 and works by interfering with a polymerase enzyme central to the production of viral RNA particles.

There has been no evidence of resistance to the drug in SARS-CoV-2, although that was observed in experiments involving Ebola, the viral disease for which it was originally developed.

Scientists have suggested that – theoretically at least – SARS-CoV-2 could see similar changes in polymerase that could reduce Veklury’s efficacy.

https://pharmaphorum.com/news/gilead-says-veklury-should-work-against-covid-19-variants/

Biden likely to ditch Trump’s plans to relax digital health regulations

 President Joe Biden looks likely to ditch the previous administration’s move to create a quicker route to market for digital health products and other devices following the pandemic emergency.

After he took office on Wednesday, Biden quickly moved to freeze a raft of Trump policies, including the moves to loosen regulations on devices including digital health products.

Only last week, the FDA had posted plans with the US Department of Health and Human Services (HHS) to allow certain medical devices including “low risk” digital health apps to be exempt from its usual premarket notification requirements.

The regulatory process known as 510(k) had been temporarily waived during the COVID-19 emergency and the proposal would have made the move permanent.

It was part of a plan to create a fast route to market for products that have helped to support the US health system during the COVID-19 crisis.

The 510(k) process already gave considerable regulatory leeway for new products, allowing the FDA to wave products through to market that it found to be “substantially equivalent” to another legally marketed predecessor.

But it looks like the Biden administration is taking a more long-term view about the regulations and how they apply to digital health.

Legal experts from the law firm Hogan Lovells noted that the proposals to drop the process “fly in the face” of an action plan to regulate artificial intelligence (AI) in healthcare.

That called for an expanded regulatory framework for machine learning devices and a more careful review of products that rely on AI.

The team from Hogan Lovells said that the exemptions remain in place for seven of the devices, all of which are gloves.

But the proposal will not take effect regarding 83 other devices unless the Biden administration decides to pursue it.

Filings for the kinds of devices covered by the notice are still being submitted and accepted by the FDA and meanwhile the HHS is still accepting comments on ways to improve the premarket approval process known until 16 March.

https://pharmaphorum.com/news/biden-puts-brakes-on-trumps-plans-to-relax-health-app-regulations/