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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

Measles Alert, Ministry of Health concerned about Patients

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The Ministry of Health and Human Services is asking all clients seen at the Cheshire Hall Medical Center Emergency Department on April 21, 2024, April 22, 2024, and May 3, 2024, to remain vigilant for any signs and symptoms of Measles. Any signs and symptoms noted must be reported immediately to your doctor.

As a reminder, the signs and symptoms of measles are:

  • Fever
  • Red rash (starts behind the ear and then spreads to the head and neck then body)
  • Coryza (runny nose)
  • Cough
  • Conjunctivitis (red eyes)
  • Body aches

Small greyish-white spots with a bluish-white center inside the mouth, cheek, and throat.

Measles is highly infectious and can be spread quickly in persons who are unvaccinated. If you think that you have been in contact with someone with symptoms of measles, please do not hesitate to see your doctor. For more information please call (649) 338-5469. For further information please visit the Ministry of Health and Human Services Facebook page at https://www.facebook.com/tciministryofhealth/.

 

 

 

 

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Caribbean News

Belize, Jamaica and St. Vincent and the Grenadines eliminate mother-to-child transmission of HIV and Syphilis 

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Belize, Jamaica, and St. Vincent and the Grenadines are the latest countries in the Americas to receive certification from the World Health Organization (WHO) for eliminating the mother-to-child transmission of HIV and syphilis (EMTCT). The milestone was marked today at a commemorative event organized by the Pan American Health Organization (PAHO) in Kingston, Jamaica, with support from UNICEF and UNAIDS and with the participation of health ministers from the three countries.

 

“This achievement is a testament to years of dedication, hard work, and collaboration among governments, health professionals, and communities”, PAHO Director Dr. Jarbas Barbosa said at the event. Dr. Barbosa also acknowledged the “remarkable resilience” displayed by the three countries, ensuring the adaptation and continuation of essential services despite the challenges posed by the COVID-19 pandemic. “I trust that the celebration today will inspire other countries to reinvigorate their commitments” towards a generation free of HIV and congenital syphilis.

 

In 2010, countries of the Americas committed to the elimination of mother-to-child transmission of HIV and syphilis and endorsed the regional strategy, which was updated in 2016 under the PAHO Plan of Action for the Prevention and Control of HIV and Sexually Transmitted Infections.

 

To meet elimination targets, countries focused on strengthening prevention and treatment services within primary health care and in maternal and child health, updating guidelines, ensuring the effective screening of pregnant women, monitoring cases and following-up with HIV and syphilis exposed infants.

 

In a video message, WHO Director-General Dr. Tedros Adhanom Ghebreyesus, praised Belize for integrating primary disease prevention and treatment into maternal and child health services. He also commended Jamaica for its civil society organizations’ commitment to human rights and lauded St. Vincent and the Grenadines for investing in robust national laboratory structures. “While validation is a tremendous accomplishment, maintaining it requires sustained efforts to prevent new infections,” he said. “WHO and partners will continue to support all countries in the Americas to strengthen health systems, provide comprehensive services, and ensure the involvement of women in planning and service delivery.”

 

Globally, 19 countries and territories have now been certified for eliminating mother-to-child transmission of HIV and/or syphilis, with 11 of them located in the Americas. In 2015, Cuba made history by becoming the first country in the world to achieve the dual elimination of HIV and syphilis. This was followed by Anguilla, Antigua and Barbuda, Bermuda, Cayman Islands and Montserrat and St. Kitts and Nevis in 2017, and Dominica in 2020.

 

“The end of AIDS is an opportunity for a uniquely powerful legacy for today’s leaders. We are again celebrating a great public health milestone today as Caribbean countries show global leadership in the elimination agenda to achieve an HIV free generation,” Christine Stegling, UNAIDS Deputy Executive Director, said.

 

New HIV infections among children in the Caribbean decreased by 25% between 2010 and 2022. During that period, annual notified cases declined from 2,000 to 1,500. Reported cases of congenital syphilis in the English-speaking Caribbean now stand at 36 cases per 100,000 newborns, below the goal of no more than 50 cases per 100,000 newborns.

 

“UNICEF welcomes the commitment of Belize, Jamaica and Saint Vincent and the Grenadines for achieving the double elimination of vertical transmission for HIV and Syphilis”, Garry Conille, UNICEF Regional Director for Latin America and the Caribbean, said. “We are confident that this milestone will be a catalyst for other countries in the region to pursue the Elimination of Mother-to-Child Transmission Agenda toward the 2030 target: No child left behind in the progress to end AIDS,” Conille added.

 

WHO awards this certification to countries which have brought the mother-to-child HIV transmission rate to under 5%; provided antenatal care and antiretroviral treatment to more than 90% of pregnant women; reported fewer than 50 new cases of congenital syphilis per 100,000 newborns, and achieved an HIV case rate of fewer than 500 per 100,000 live births.

 

Elimination Initiative

 

The PAHO Elimination Initiative seeks to put an end to more than 30 communicable diseases, including the mother-to-child transmission of HIV and syphilis, in Latin America and the Caribbean by 2030.

 

The initiative was relaunched during the Organization’s 60th Directing Council and seeks to harness the lessons learned from the COVID-19 pandemic, as well as from previous elimination experiences to accelerate disease elimination in the Region.

 

Quotes from Ministers of Health

 

Kevin Bernard, Minister of Health and Wellness of Belize: “Eliminating mother to child transmission of HIV and syphilis is an extremely significant accomplishment for the people and the country of Belize. The activities leading up to this momentous goal were not always easy, however with the commitment and motivation of our health care workers, in all areas of health, this has become a reality. We continue to work towards achieving public health goals for a healthier and more productive Belize.”

 

Dr. Christopher Tufton, Minister of Health and Wellness of Jamaica: “The elimination of mother-to-child transmission of HIV and syphilis is a win that underscores protecting the health of all. It is also exemplary of the extraordinary progress being made in our maternal health care. What’s more, it is vitally important that we consolidate the gains made from this achievement, especially through continued community engagement and partnership in the public health interest of all.”

 

St. Clair Jimmy Prince, Minister of Health, Wellness and the Environment of St Vincent and the Grenadines: “I commend the dedication and commitment of healthcare workers on achieving certification by the World Health Organization (WHO) of the dual elimination of mother to child transmission (EMTCT) of HIV and syphilis. This achievement signals to the world that ending paediatric HIV and congenital syphilis through the elimination of mother to child transmission of HIV and syphilis is achievable. The Ministry will continue to work towards ending AIDS as a public health threat by 2030.”

 

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Health

Ministry of Health and Human Services Confirm Two Measles Cases 

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Grand Turk, Turks and Caicos Islands – 11th May 2024: On Thursday, 9th May 2024, results of testing for two suspected measles cases were received from the Caribbean Public Health Agency, confirming that both cases were positive for measles. These represent the first cases of measles in the TCI since 1991.

The public health team has been responding since initial reports of the suspected cases, carrying out contact tracing, isolation, public education and outreach in anticipation of yesterday’s results. No additional suspected cases have been identified at this time. All unvaccinated contacts of the confirmed cases have been vaccinated. Additional vaccination efforts will be conducted throughout the TCI.

The public health team has been receiving technical support from its key stakeholders including the Caribbean Public Health Agency (CARPHA), UK Health Security Agency (UKHSA) and Pan American Health Organisation (PAHO).

Measles is a highly infectious disease caused by a virus that spreads easily between people. Symptoms typically start between 10 and 12 days after catching the infection. The signs and symptoms of measles are:

  • A high fever
  • Runny or blocked nose
  • Cough
  • Red, sore, watery eyes

Small greyish-white spots with a bluish-white center inside the mouth, cheek, and throat may appear a few days later. A rash usually appears 2-4 days after the cold-like symptoms start. The rash starts on the face and behind the ears before spreading to the rest of the body.

Measles is spread through close contact with someone with measles. This could be through droplets in the air which are generated by the coughs and sneezes of infected persons or by touching things that someone with measles has coughed or sneezed on.

Measles spreads easily within households and in other places where people mix closely together. Measles is so contagious that if one person has it, up to 90% of the people close to that person who are not immune will also become infected. The period when a person is infectious and can spread the virus is within 7 to 10 days of exposure but can be up to 14 days.

Most measles-related deaths are caused by complications associated with the disease and serious complications are more common in children under the age of 5, or adults over the age of 30 and individuals whose immune systems have been weakened. The most serious complications include blindness, encephalitis (an infection that causes brain swelling), severe diarrhoea and related dehydration, ear infections, or severe respiratory infections such as pneumonia. Women infected while pregnant are also at risk of severe complications, and the pregnancy may end in miscarriage or preterm delivery. People who recover from measles are immune for the rest of their lives.

Any non-immune person (who has not been vaccinated or was vaccinated but did not develop immunity) can become infected.

No specific antiviral treatment exists for measles virus.
Severe complications from measles can be avoided through supportive care that ensures good nutrition, adequate fluid intake and treatment of dehydration with WHO-recommended oral rehydration solution. This solution replaces fluids and other essential elements that are lost through diarrhoea or vomiting. Antibiotics should be prescribed to treat eye and ear infections, and pneumonia.

A number of measles outbreaks have been detected globally and regionally. While the TCI has high vaccination coverage in the measles, mumps and rubella vaccine (MMR) (>95%), unvaccinated persons can still acquire measles through contact with an infectious person.

Having the MMR vaccine is the best way to prevent measles. The vaccine is safe and effective in providing long term protection against measles, mumps and rubella. Vaccines are offered free of cost to all children at government-operated primary care facilities across the TCI.

The Ministry of Health and Human Services encourages parents to ensure that their children’s vaccines are up to date.  If you are unsure if you or your child has had 2 doses of the MMR vaccine, please visit your health care provider. If you have missed a dose, you can still be vaccinated at any age.

The public is being advised to remain vigilant and report any fever with rash or fever followed by rash to their doctor/health care provider as soon as possible.

The Ministry of Health and Human Services is grateful for the support of its stakeholders, including CARPHA, who provided the results of testing in such a prompt manner.
The Ministry of Health and Human Services will continue heightened surveillance for fever and rash and take necessary actions to mitigate against further cases.

For additional information please call 649-338-5469 or visit the Ministry of Health and Human Services Facebook page at https://www.facebook.com/tciministryofhealth/.

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