#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.
Polio is back; 65 million missed shots in another COVID fall out
By Dana Malcolm
#USA, August 4, 2022 – For the first time in almost a decade a new case of polio was recorded in the United States. The case which ended in paralysis emphasizes the danger the region faces as vaccination levels drop to 30-year lows.
The World Health Organization warned in early July explained that vaccination in the region of the Americas and the rest of world was dropping rapidly because of various spin off effects precipitated by the Coronavirus Pandemic.
Over 65 million infants missed out on basic vaccines in the last three years thanks to disruptions in routine healthcare, lockdowns and other circumstances. The effects are already being felt as once eradicated disease like measles and polio are once again emerging.
The Pan American Health Organization announced earlier this year the Americas are now facing another measles outbreak after having been declared free of the disease in 2016.
Dr. Jarvis Barbosa, Assistant director of PAHO said vaccination levels are now as low as they were in 1994 for measles and polio and Brazil has had several outbreaks of measles.
In the case of the United States an unvaccinated young adult developed the disease after contact with another individual vaccinated with a live version of the vaccine.
The breakout polio case in the US sent shockwaves across the country because of the severe nature of the disease. Polio is an extremely dangerous disease with no known cure. It causes paralysis in as many as 1 in 200 infected and that paralysis is permanent.
Normally very few school age children would be at risk in the Americas as the vaccine is required to start school but with the gap in vaccinations many more children are now at risk.
Polio was one of the most feared diseases of the 20th century, paralyzing and killing hundreds of thousands, especially children. Thankfully vaccinated individuals are not at risk and as such the WHO is advising that the best way to protect against polio is vaccination.
Photo Caption: Child in Benin takes Polio vaccine, UNSDG
Kansas first to establish Roe v Wade Laws following US Supreme Court decision to remove ABORTION as a right from Constitution
By Dana Malcolm
#Kansas, USA, August 5, 2022 – Voters in the state of Kansas have moved to uphold abortion rights in their state. Kansas legislators will now be prevented from putting restrictions or bans on abortion. In order to do so they would have to call for a constitutional review, a lengthy drawn out process.
“Kansans stood up for fundamental rights today. We rejected divisive legislation that jeopardized our economic future & put women’s health care access at risk,” Laura Kelly, Kansas’ Democratic Governor tweeted on Wednesday.
Kansas is the first state to put the issue on the state ballot since Roe v Wade the case making abortion a constitutional right was overturned at the Supreme Court level and US media
President Biden proclaimed his support for the bill encouraging congress to write Roe v Wade into law.
Roe v Wade was overturned on June 24, nearly 50 years after it was won.
CARPHA Supports Breastfeeding as a Long-Term Strategy for a More Productive and Healthier Region
August 5, 2022 – Exclusive breastfeeding for 6 months benefits the infant, mother, family, community, country and environment,” states Dr. Joy St. John, Executive Director at the Caribbean Public Health Agency (CARPHA). “Therefore, breastfeeding is recognised as an effective strategy in achieving regional and global goals on health, nutrition, food security, economic growth and environmental sustainability.
The World Health Organization (WHO) and United Nations Children’s Fund (UNICEF) recommend that breastfeeding be initiated within 1 hour of birth, continued exclusively for the first 6 months of life, and that nutritionally-adequate and safe complementary (solid) foods be introduced at 6 months together with continued breastfeeding up to 2 years of age or beyond.
Early initiation of breastfeeding is critical to newborn survival, reducing their risk of morbidity and mortality. Breastmilk provides optimal nutrition for infants for their physical and mental growth and development, along with antibodies to prevent and mitigate childhood illnesses.
Breastfeeding reduces the risk of over-nutrition (overweight and obesity) and non-communicable diseases (NCDs) for both mother and child. Infants that are breastfed longer, have 13% lower risk of overweight and obesity and 35% lower risk of type 2 diabetes. Women who breastfeed have reduced risks of postpartum overweight and obesity, 32% lower risk of type 2 diabetes, 37% lower risk of ovarian cancer and 26% lower risk of breast cancer4.
In Latin America and the Caribbean, many infants and young children do not meet the WHO and UNICEF recommendations for breastfeeding and ultimately lose out on its many benefits. Only 54% of infants initiate breastfeeding within 1 hour of birth; 37% breastfeed exclusively for the first 6 months of life which is below the global rate (44%); and between 31%-55% of children continue to receive breastmilk up to 2 years of age2.
Breastfeeding, more so when occurring exclusively, allows for healthier mothers and children who can in turn contribute meaningfully to the community and society at large. There is a reduced tax burden on communities and governments to ensure children are properly fed. Additionally, more funding is made available for community and national development. Reports indicate that the total global economic losses of not breastfeeding are estimated to be US$341.3 billion.
Breastfeeding is a naturally renewable resource that is environmentally sustainable as it does not require the use of natural resources (not even water!), provides no waste for accumulation in landfills (no packaging or disposal), and it does not pollute the environment.
Breastfeeding also contributes to infant and household food security. Infants who are breastfed exclusively, require no other source of nutrition and are less likely to get sick thereby lessening the financial burden on the family. This allows for nutritious foods to be bought for other members of the family. This is especially important during times of economic crises, such as those experienced during the COVID-19 pandemic, where many households face unemployment and loss of income. The pandemic has proven to be a global threat to breastfeeding. Two recent studies in Western countries reported a decline in early initiation, exclusive and continued breastfeeding rates due to the pandemic, with one major contributing factor being a loss in support for mothers,.
Breastfeeding is particularly effective against infectious diseases because it strengthens the immune system by transferring antibodies from the mother to the child. Mother to child transmission of SARS-CoV-2 through breastmilk has not been found to occur. The WHO and UNICEF recommendations on initiation and continuation of breastfeeding infants and young children also apply to mothers with suspected or confirmed coronavirus disease as the benefits far outweigh any potential risks. Mothers with suspected or confirmed COVID-19 are encouraged to practice respiratory hygiene (wearing a mask when breastfeeding), hand hygiene (frequent hand washing, including before and after touching the baby), and routinely clean and disinfect surfaces. If the mother is too unwell to breastfeed, she can be supported to feed expressed breastmilk or to relactate (re-introduce breastfeeding after a period of cessation).
This year’s theme for World Breastfeeding Week “Step up for Breastfeeding – Educate and Support” is aligned with thematic area 1 of the WBW-Sustainable Development Goals 2030 campaign which highlights the links between breastfeeding and good nutrition, food security and reduction of inequalities. It will focus on strengthening the capacity of actors that have to protect, promote and support breastfeeding across different levels of society.
We all form part of the warm chain of support of breastfeeding – whether we are from or represent governments, health systems, workplaces or communities – and have a shared responsibility to protect, promote and support breastfeeding. Let us all inform, anchor, engage and galvanise action to protect and support breastfeeding. A whole-of-society approach is needed to facilitate the development and implementation of regional breastfeeding policies and creating a breastfeeding-friendly environment.
This is in keeping with the Caribbean Public Health Agency’s (CARPHA) life course approach for the prevention of NCDs of which breastfeeding is a key factor. CARPHA supports breastfeeding as a long-term strategy for a more productive and healthier Region and encourages mothers and families to see breastfeeding as the optimal feeding method for infants.
CARPHA has led training in the WHO/UNICEF 40 Hour Breastfeeding Counselling Course; and training of Health Professionals in the 20-Hour Course for Baby Friendly Hospital Initiative as well as implementation and certification. The Agency has also supported Member States with the development of National Infant and Young Child Feeding Policies, Hospital Breastfeeding Policies and developed guidelines for anyone involved in the care and management of newborns, and pregnant or lactating women suspected of or confirmed to be infected with the COVID-19 virus.
CARPHA calls upon its member states to take a whole of society approach and implement and reinforce the International Code of Marketing of Breast-milk Substitutes and the Ten Steps to Successful Breastfeeding. By protecting and supporting breastfeeding, we are also protecting human rights and taking important steps towards achieving the Sustainable Development Goals, leaving no one behind in the post pandemic world.
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