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So far Johnson & Johnson Vaccine approved for US use only; roll out in States by end of March

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#USA, March 1, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) on February 27 (2021) announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”

Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines.

Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.

The EUA follows a unanimous vote by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021.

“We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Through the combined commitment of everyone involved, we have been able to discover, develop and manufacture a single-shot COVID-19 vaccine to protect people around the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.

Health

Dengue cases rising in Region 

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Dana Malcolm 
Staff Writer 

As of March 26, 2024, over 3.5 million cases of dengue and more than 1,000 deaths have been reported in the region, now, both the US Centres for Disease Control (CDC) and the Pan-American Health Organization (PAHO), are ringing alarm bells about the outbreak as cases swell to record highs.

PAHO on March 28 called for collective action in the region to fight back the growing wave of infections.

“This is cause for concern, as it represents three times more cases than those reported for the same period in 2023, a record year with more than 4.5 million cases reported in the region,” Jarbas Barbosa, PAHO Director said during a press briefing.

For now cases are concentrated in three main countries: Brazil, Paraguay and Argentina which account for nearly all of them, around 92 percent, but infections are on the rise regionally.

According to Barbosa, Caribbean countries must still be vigilant as data is beginning to show increases in areas like Barbados. That is paired with concerns from PAHO that some countries may not be equipped to handle the surge.

Nearly $500,000 was allocated in the 2023 2024 budget to the environmental health department under The Turks and Caicos Ministry of Health and Human Services to help with dengue which had been listed as a public nuisance.

Last year in the Turks and Caicos Islands, only a few rounds of fogging were completed. According to data from the Appropriations Committee around 10% of communities were fogged on schedule. Explaining the low number, representatives of the Environmental Health Department (EHD) maintained that fogging was not the primary defense against mosquito breeding locally.

”Fogging should actually be a last resort, there are preventative measures such as the treatment of swamps, and inspection of residential areas and communities for breeding sites.”

Representatives admitted though that they were still hampered by a lack of resources.

The country declared an outbreak in late 2024. Now there is an ongoing public education campaign to make residents aware of what they need to do to keep their homes safe and free from mosquitoes in addition

The Turks and Caicos Islands EHD also says they have been provided with money to help with garbage disposal in their battle against the vector borne disease.

The Ministry has also contracted entomologists to research what kind of mosquitoes live in the country and how to tackle them.

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Health

31 Turks & Caicos Medical Professionals, Trained in Trauma care

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Dana Malcolm 
Staff Writer 

In a first for the Turks and Caicos and one that some would describe as particularly important, over three dozen healthcare professionals were upskilled in emergency trauma care via Advanced Trauma Life Support (ATLS) certification.

Trauma Care in emergency medicine usually refers to treating patients who are critically ill or have severe injuries and need to be quickly stabilized like gunshot wounds, damaged limbs, crush injuries, and stab wounds.

In 1976 following a plane crash involving a surgeon and his children who experienced substandard trauma care, the first ATLS course was created. It attempts to provide basic training for medical professionals when dealing with acute trauma cases where there is little staff on hand. In fact ATLS is supposed to work with as little as a single doctor and nurse team working together to stop the most critical injuries first, ensuring a better chance of survival.

This is particularly useful for the Turks and Caicos with its small hospitals and limited staff. Health officials admitted this, highlighting what they describe as ‘the pressing need for such training, particularly due to physician shortage, isolated communities in family islands and other barriers to accessing this critical training.’

Recognizing the need, the Hamilton Education Foundation jumped into action, and in collaboration with Massachusetts General Hospital and the American College of Surgeons conducted a Hybrid Advanced Trauma Life Support (ATLS) Demo for 31 doctors in the Turks and Caicos Islands on May 22nd and 23rd, 2024.

Led by Professor Susan Briggs,the foundation describes the course as historic in that it’s the first-ever done outside the United States and says it is;“Crucial for enhancing the quality of healthcare delivery and saving lives in the face of increasing intentional and unintentional injuries.”

With the rise in gunshot injuries in the country, seen through police data since 2020 many residents might be inclined to agree.

While admitting it was difficult to measure if ATLS reduced mortality, a 2016 article published in the National Library of Medicine describes the courses as “very useful from an educational point of view. It significantly increased knowledge, and improved practical skills and the critical decision making process in managing multiple trauma patients”

Rufus Ewing, Former Premier and Executive Chairman of the Hamilton Education Foundation, said, “This initiative aligns with our mission to enhance medical education and improve access to quality healthcare services in the Turks and Caicos Islands.”

The training received broad brush support from the Ministry of Health, TCI Hospital and private sector.

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Caribbean News

Dengue surges in Argentina; Repellent shortage reported

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Rashaed Esson

Staff Writer 

 

#Argentina, April 15, 2024 – Argentina is currently facing a shortage in mosquito repellents, a severely unfortunate development for the nation as it is now fighting a surge in dengue cases, in-line with PAHO predictions that the region will face its worst dengue season on record.

The mosquito repellent shortage was reportedly noticed in March 2024 and Argentina, according to the Ministry of Health, recorded over 163,000 cases with deaths in all age groups, more common for those over 80 years old.

The situation is widespread across Argentina as indicated by supermarkets putting on display “no repellent” signs.

Places where repellents are still available,  online spaces especially, are selling them at high prices.

As to the reason behind the shortage, BBC reports that it was told by one of the production companies (for repellents), that a forecast error was at fault and that manufacturing took months.  Additionally, mirroring this,  Mario Russo reports a supply and demand problem.

The Government is making efforts to have this sorted as soon as possible, but Argentinians, reports say, are not so hopeful as hundreds of thousands have already been infected.

Preventative measures such as repellents are crucial for Argeniniand who reply heavily on them, as they await the dengue vaccine which is already developed, but still In its early stages of distribution.

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