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Before second COVID-19 Summit, United States promises to redouble its efforts in global response and immunisation

by Medically Speaking May 11, 2022

written by Medically Speaking

On May 12, world leaders will assemble to discuss critical next measures in the global COVID-19 response, and the United States has pledged to redouble its efforts for a worldwide response, including vaccination, ahead of the second COVID-19 summit, which will be held online.

The United States, Belize, Germany, Indonesia, and Senegal are the co-hosts of the Second Global COVID-19 Summit, which brings together governments from across the world to make specific promises to vaccinate the world, save lives today, and build improved health security. The Summit will redouble our efforts from the first COVID Summit and will focus on four essential objectives: recommitting to global response intensity; vaccinating the globe; safeguarding the most vulnerable; and avoiding repeat disasters, according to a White House statement.

South Africa, Canada, Japan, India, Colombia, Republic of Korea, Italy, New Zealand, European Commission, Spain, Nigeria, Norway, Palau, Tanzania, and Rwanda will also participate in the virtual summit.

Other partners, including non-governmental organisations and private-sector firms, have made financial or policy commitments. Wellcome; Google; FIND, the global diagnostics alliance; Rotary International; the Coalition for Epidemic Preparedness Innovations; the Clinton Health Access Initiative; Open Society Foundations; the Bill and Melinda Gates Foundation; Gavi, The Vaccine Alliance; and the Mastercard Foundation will be among those involved.

In addition, international and regional institutions such as the World Health Organization, World Bank Group, World Trade Organization, African Centres for Disease Control and Prevention, and Caribbean Public Health Agency will participate, according to the release.

President Biden and other heads of state from the co-host nations will open the Summit by emphasising the importance of combating COVID-19 as a worldwide priority.

The Summit will next comprise three sessions focusing on gaining access to testing and treatments, enhancing health security, and preventing future disasters.

The US called on leaders of governments, civic society, corporations, and philanthropies to make major new commitments ahead of the Summit, according to a statement.

To far, President Obama has pledged to sharing 1.2 billion doses of safe, effective vaccinations with the rest of the world, and the United States has delivered on that promise.

The United States has supplied over 530 million doses of vaccine to 115 nations throughout the world, more than four times the next closest contributor. The US has also supplied them free of charge with no strings attached, according to the statement.

The United States and the co-host countries are looking forward to another successful Summit to help speed the worldwide response to COVID-19 and promote global pandemic preparation.

May 11, 2022 0 comment

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Omicron widens racial disparity in US, Covid-related diabetes likely to be temporary: Research

by Medically Speaking February 28, 2022

written by Medically Speaking

According to a new study, patients with severe Covid-19 symptoms who develop diabetes during hospitalisation may only have a transient version of the condition, with their blood sugar levels returning to normal afterward. During their stay in the hospital for Covid-19 treatment, researchers looked at 594 patients who showed indications of diabetes. There were 78 patients who had never been diagnosed with diabetes before.

Many people freshly diagnosed with diabetes had less severe blood sugar concerns than patients with pre-existing illnesses. They did, however, have more severe Covid-19 symptoms.

Forty per cent of these patients went back to blood sugar levels below the diabetes cutoff roughly a year after leaving hospitals, the researchers reported in the Journal of Diabetes and Its Complications.

OMICRON and RACIAL DISPARITIES

Co-author Dr Sara Cromer of the Boston-based Massachusetts General Hospital said that this suggested that the new diabetes diagnosis might be transitory and related to the acute stress of being infected with Covid-19, Reuters reported.

The results suggest that insulin deficiency, in case it occurred, is not permanent in general, Dr Cromer said. She added that these patients might only need insulin or other similar medications for a brief period and it was critical that physicians closely followed them to see when their conditions improved.

According to new research, the increase in Omicron-led infections in the United States, as well as the higher toll on minority populations, is the latest illustration of racial imbalance during the epidemic.

When the Delta strain was dominant, about one person in every 2,000 in the United States was infected for the first time every day. In January, when Omicron became the prevalent strain, researchers discovered that roughly 8 to 10 people were infected per day.

The researchers published on medRxiv, ahead of peer review, that Omicron expanded racial gaps even more.

During the Delta strain’s dominance, the infection rate among Black patients was 1.3 to 1.4 times greater than white patients. With Omicron, the rate of infection jumped to 3 to 4 times higher, Reuters reported. Among Hispanics, the rate of Delta infection was 1.6 to 1.8 times higher than non-Hispanics. This number grew to three times higher with Omicron.

The Omicron strain also hit children. The rate of infection in January in children under 5 was the highest at 22 a day per 2,000.

733,509 Delta cases and 147,964 Omicron cases were used to compile the results. The Omicron variation, on the other hand, resulted in a considerable reduction in emergency room visits, hospitalizations, intensive care unit admissions, and the need for mechanical breathing. Hispanics and Blacks had more emergency visits and required more intense care. The study’s participants may not be representative of all patients in the United States, according to the researchers.

February 28, 2022 0 comment

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Omicron caused more deaths than Delta in US: Report

by Medically Speaking February 22, 2022

written by Medically Speaking

The Omicron wave is breaking, but deaths in the United States have overtaken those from the Delta wave, according to The Seattle Times.

According to the newspaper, since November 24 last year, when South Africa first reported the Omicron form to the World Health Organization, the US has confirmed more than 30,163,600 new infections and 154,750 new deaths.

In comparison, the government reported 10,917,590 new infections with 132,616 new deaths from August 1 to October 31 in 2021, a similar period covering the worst of the Delta surge in the United States, according to the report.

The death toll during the Omicron wave is about 17 per cent higher than that in the equivalent-length Delta period.

The death toll underscored “the country’s continuing vulnerability,” the report said, adding “when the number of infections is as astronomical as 30 million, even a tiny death rate will mean a catastrophic death count.”

February 22, 2022 0 comment

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The United States will allow travellers who received Covid vaccines in mixed doses to enter the country

by Medically Speaking October 17, 2021

written by Medically Speaking

Key Highlights

While the CDC in the United States does not allow mixed vaccines in primary series, it is fairly common in other countries.
The US Centers for Disease Control and Prevention previously stated that it would accept any vaccines approved by the US regulator or the World Health Organization.
Beginning November 8, the United States will relax Covid-19 travel restrictions for international passengers.

International visitors who have been immunised with a combination of Covid vaccines will now be permitted to enter the United States. The Centers for Disease Control and Prevention (CDC) in the United States confirmed on Friday that they will accept mixed-dose vaccines from international travellers.

“While the CDC does not recommend mixing vaccine types in a primary series, we recognise that this is becoming more common in other countries and should be accepted for the interpretation of vaccine records,” a CDC spokeswoman said.

The CDC earlier said that it would accept any vaccines approved by the US regulator or the World Health Organisation (WHO).

The US will ease Covid-19 travel restrictions for international passengers from November 8.

Additionally, the US also endorsed the booster dose of Johnson & Covid-19 Johnson’s vaccine, admitting that Americans who got the single-dose vaccine are not as protected as those who got other double-dose vaccines.

J&J told US Food & Drug Administration (FDA) that a booster dose provides additional protection as early as two months after the initial vaccine but will work better for those who get it after 6 months. The FDA’s advisory panel voted that booster shot should be taken at least 2 months after the initial vaccination.

Initial results from ongoing research suggest that J&J recipients may have a stronger response if the booster dose is from another brand. The preliminary results from a new study catering to effects of taking competing vaccine brands showed that booster shot from a competing vaccine jacked up virus-fighting antibodies — at least for a few weeks and it was most effective from taking a Pfizer or a Moderna booster shot after a J&J vaccine.

October 17, 2021 0 comment

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PM Modi woos global vaccine manufacturers Come, make in India

by Medically Speaking September 26, 2021

written by Medically Speaking

NEW DELHI: PM Narendra Modi made an important contribution Saturday, inviting global vaccine manufacturers “to arrive and to make vaccines in India,” to take a leading place in the global fight against Covid-19

PM Modi said at the 76th session of the UN General Assembly that “I invite the production of vaccines all over the world — come and make vaccines in India.”

“I want to inform UNGA that the first DNA vaccine in the world has been developed by India that can be administered to everyone above 12. The last phase of development of another mRNA vaccine is under way. India’s scientists are also engaged in the development of a nasal vaccine for Corona,” he said.

The invitation comes at a time when inadequate supplies and inequitable distribution of vaccines have raised the fear that the twin issues might delay global recovery from the pandemic and may appear to be a move to transform India’s image as a cause of concern that it looked after the country was ravaged by the “second wave”, into an emergency responder and part of the solution. India earned considerable goodwill when the Modi government launched “Vaccine Maitri” initiative to reach vaccines to the under-resourced capitals at a time when developed countries stubbornly refused to look beyond their shores. The second wave derailed the vaccine initiative as New Delhi decided to first look after its own.

Highlighting India’s achievements and progress in Covid vaccine development despite limited resources, the PM said the country lives by ‘Seva Paramo Dharma’ (service is the main duty) and is engaged in vaccine development and manufacturing with full dedication.

While Ahmedabad-based Zydus Cadila’s three-dose anti-Covid jab ZyCoV-D has got emergency use authorisation for those above 12 years of age, Pune-based biotechnology firm Gennova Biopharmaceuticals is working on the country’s first mRNA-based Covid vaccine. Besides, Bharat Biotech is conducting trials with a nasal vaccine.

September 26, 2021 0 comment

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According to USFDA enforcement notice, drug manufacturers Granules India and Jubilant Cadista are recalling goods in US market

by Medically Speaking September 13, 2021

written by Medically Speaking

Granules India and Jubilant Cadista, two generic medication manufacturers, are recalling a variety of goods in the United States, the world’s largest market for pharmaceuticals, for various reasons.

According to the US Food and Drug Administration’s (USFDA) latest Enforcement Report, Granules India’s US-based unit is recalling over 1.14 million Naproxen Sodium tablets, a non-steroidal anti-inflammatory drug used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout, and fever.

According to USFDA, the company’s US-based unit is recalling the affected lot due to “Current Good Manufacturing Practice (CGMP) deviations”.

The affected lot has been manufactured at Granules India’s Telangana-based plant. The lot has been distributed in the US by New Jersey-based Granules USA, Inc, the report stated.

Granules initiated the Class II voluntary recall on August 11 this year.

As per USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

USFDA further said US-based Jubilant Cadista Pharmaceuticals Inc is recalling 14,544 bottles of Donepezil HCL Tablets, which is used to treat mild to moderate dementia in Alzheimer’s disease.

The company is recalling the affected lot due to it being “subpotent,” it added.

Jubilant Cadista Pharmaceuticals is a fully-owned subsidiary of Cadista Holdings Inc, which is a part of the Noida-based Jubilant Life Sciences Company.

The affected lot has been produced by Jubilant Generics in India and marketed in the US by Salisbury-based Jubilant Cadista Pharmaceuticals, Inc.

Jubilant commenced the Class III recall in the US on August 20, 2021.

As per USFDA, a Class III recall is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”

According to industry estimates, the US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.

Shares of Granukes India ended at Rs 328 on the NSE on Thursday, down by almost 0.3 per cent from the Wednesday closing price.

September 13, 2021 0 comment

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11 Times Less Likely To Die Of Covid: US for Fully Vaccinated People

by Medically Speaking September 11, 2021

written by Medically Speaking

Washington: Compared with those not vaccinated, the risk of Covid’s dying was 11 times lower, and 10 times lower, because highly contagious delta was the commonest variant, US health authorities said Friday. Fully vaccinated patients

The figures came from three new documents published by the Centers for Disease Control and Prevention, all of which highlighted the continued effectiveness of the Covid vaccines against severe results.

For reasons that are not yet well understood, data from one of the studies suggests Moderna’s vaccine has offered a slightly higher level of protection in the Delta period.

It comes a day after President Joe Biden announced an aggressive new immunization plan that includes requiring companies employing more than 100 people to either vaccinate their workers or test them weekly.

“As we have shown in study after study, vaccination works,” said CDC director Rochelle Walenksy during a press briefing on Friday.

The first study examined hundreds of thousands of cases in 13 US jurisdictions from April 4 – June 19, the period before Delta was dominant, and compared them to June 20 – July 17.

Between these periods, a vaccinated person’s risk of Covid infection rose slightly: from being 11 times less likely to be infected compared to an unvaccinated person, to five times less likely.

Protection against hospitalization and death remained more stable, but fell more among people aged 65 and above than for younger age groups.

The CDC and the Food and Drug Administration are assessing the need for booster shots, and it is likely the elderly will be among the first to receive them when the Biden administration starts to roll them out later this month.

One of the studies, which assessed vaccine effectiveness from June-August at more than 400 hospitals, emergency departments and urgent care clinics, stratified efficacy by brand.

Efficacy against hospitalization was highest for Moderna at 95 percent; then Pfizer at 80 percent; and finally Johnson & Johnson at 60 percent.

Overall efficacy against hospitalization was 86 percent for all age groups but this fell to 76 percent for those over 75.

The two mRNA vaccines, Pfizer and Moderna, have always performed slightly better than the J&J adenovirus vector vaccine — possibly because the latter is administered as one dose.

It isn’t clear why Moderna’s vaccine appears to have a slight edge on Pfizer in the Delta period.

It could be linked to its higher dosing level of 100 micrograms versus 30 micrograms, or possibly the greater interval between the first and second shots (four versus three weeks), which might be associated with a heightened immune response.

September 11, 2021 0 comment

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To combat deteriorating vaccine efficacy, the US has approved the Covid booster shot

by Medically Speaking August 19, 2021

written by Medically Speaking

The effectiveness of the coronavirus vaccine is deteriorating with time, according to US regulators, who have authorised booster shots for all Americans starting on September 20th, eight months after they have been fully inoculated.

The development comes as scientists and health professionals dispute whether a third injection of the Pfizer-BioNTech and Moderna vaccines would be helpful in combating the Delta strain of Covid-19, which is on the rise.

“The available data make very clear that protection against (coronavirus) infection begins to decrease over time following the initial doses of vaccination, the nation’s top health officials, including Centers for Disease Control and Prevention director Rochelle Walensky and US Surgeon General Vivek Murthy, said in a statement.

“In association with the dominance of the Delta variant we are starting to see evidence of reduced protection against mild and moderate disease,” they added.

The officials warned that while the vaccines remain “remarkably effective” in reducing the risk of severe disease, hospitalization and death from the effects of Covid, protection could diminish in the months ahead without boosted immunization.

“We conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability,” the officials said.

The boosters would be available beginning the week of September 20, with individuals eligible for a shot starting eight months after receiving a second dose of the Pfizer or Moderna vaccines.

The officials said they also anticipate booster shots will be needed beginning later in the year for people who received the Johnson & Johnson vaccine, which rolled out in March.

Over 620,000 people have died in America from coronavirus, with case numbers increasing sharply in recent months due to the spread of the Delta variant.

August 19, 2021 0 comment

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As the Delta version becomes more common, the US will propose booster shots for everyone

by Medically Speaking August 18, 2021

written by Medically Speaking

As the Delta strain of the virus spreads swiftly across the country, US health officials are anticipated to suggest an extra dose of COVID-19 vaccine for all Americans.

A source familiar with the decision told the Reuters news agency that health officials in US President Joe Biden’s administration will suggest that most people get a booster shot eight months after their initial vaccine.

The extra jabs could begin as early as mid or late September, pending authorisation from the US Food and Drug Administration, the source said.

The forthcoming recommendation by the US Centers for Disease Control (CDC), telegraphed by US officials last week, is being driven by both the highly contagious new variant of the virus and early signs that protection from vaccines fades within months.

The move means that the biggest mass vaccination drive in US history, which has been only partially successful, will have to expand and continue.

The US is experiencing a fourth wave of the pandemic as the Delta variant spreads aggressively through unvaccinated communities in the US – notably southern states of Florida, Alabama, Mississippi, Louisiana and Texas – and causing an increasing number of “breakthrough infections” of fully inoculated people.

US has fully vaccinated 168 million people, or about 62 percent of the adult population as of August 16, according to the CDC. Those numbers are below benchmarks set by the Biden administration for the national vaccination programme by now.

The US now is admitting to hospital more than 11,000 people a day with symptoms of COVID-19, according to the CDC.

Alabama Governor Kay Ivey issued an emergency order on Friday as the state’s hospitals faced a surge in COVID-19 cases and available intensive care beds were filled up with the very ill.

“We have to really make sure that while we’re spending a lot of time and effort on third doses that we don’t undermine our campaign for first vaccinations,” Lawrence Gostin, a public health specialist at Georgetown University, said Tuesday.

“That’s truly the existential crisis in the United States,” Gostin told The Associated Press.

One positive trend in the US, vaccination rates have been increasing as people see the virus resurge.

Harris County, Texas, home to the US’s fourth-largest city Houston, is offering people $100 gift cards to get jabs in the latest incentive offered by local officials to boost the area’s lagging vaccination rate, according to the Houston Chronicle newspaper.

In New York, the governor has ordered that all healthcare workers in the state including at hospitals and nursing homes receive a vaccine against COVID-19.

Biden issued an order on Tuesday directing the Federal Emergency Management Agency (FEMA) to cover 100 percent of local costs for emergency measures and provide federal support for state governor’s use of the National Guard to staff mass vaccination sites.

August 18, 2021 0 comment

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Sun Pharma has agreed to commercialise a skincare product in the US via an in-licensing agreement

by Medically Speaking July 27, 2021

written by Medically Speaking

Sun Pharmaceutical Industries NSE -2.54 percent, based in Mumbai, has inked an in-licensing deal with Cassiopea SpA, an Italian pharmaceutical business, to commercialise Winlevi (clascoterone cream 1% ) in the United States and Canada.

According to a company statement, the US Food and Medicine Administration (FDA) has authorised Winlevi as a novel drug with a unique mechanism of action for the topical treatment of acne in patients aged 12 and up.

Under the terms of the above referred agreements, Sun Pharma will have the exclusive right to commercialize Winlevi in the United States and Canada, and Cassiopea will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of $45 million, potential commercial milestones totalling up to $190 million and customary double digit royalties.

Acne, being the most prevalent skin condition in the US, affects up to 50 million Americans annually. The last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago. Winlevi is expected to be available in the US in Q4 calendar 2021, added the statement.

“Winlevi is a new class of topical medication in dermatology and will complement our existing oral acne portfolio. The addition of Winlevi further strengthens our position in the acne segment and reinforces our deep commitment to caring and making a difference in the lives of patients,” said Abhay Gandhi, CEO, North America of Sun Pharma.

“Following this transaction, Cassiopea will be expecting substantial revenue streams for the foreseeable future and will be well funded to continue the development of its innovative dermatology pipeline,” said Diana Harbort, CEO of Cassiopea SpA.

July 27, 2021 0 comment

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