The Palo Alto City Council has given nonprofits that rent space at the Cubberley Community Center a break by granting them three months of rent relief to help them restart operations that had been slowed by the COVID-19 pandemic.
During a discussion last Monday, the city council also directed its Policy and Services Committee to explore further measures that could support businesses that provide services such as child care or music lessons.
Notably, Palo Alto anticipates a budget deficit of about $7 million in fiscal year 2022, which begins July 1; meanwhile, it already suffers from $4.8 million in debt.
The gap between the two fiscal years is intended to be reduced, in large part, by drawing resources from a special reserve the city had established last year to deal with unforeseen impacts of the pandemic, as well as by eliminating the travel budget for city staff and reducing administration expenses.
During the same session, the council ratified eliminating dozens of positions at City Hall due to falling revenues, so 83 full-time and 107 part-time positions across the organization will not be returning anytime soon.
However, despite the shortfall, council members agreed to waive about $203,000 in rent payments for the 19 tenants who qualify for relief under the approved rules.
The exemption will apply only to "small organizations," those that had revenues of less than $2.5 million in 2019, and those that were forced to stop operations due to the pandemic.
"We've asked other landlords to be flexible; I think we have a responsibility to do it ourselves," Councillor Alison Cormack said at the time.
Faced with divided opinions over the eligibility of businesses to qualify for the aid, Councilman Greg Lin Tanaka suggested the city delay approving the aid program and spend more time determining who should qualify.
During the meeting he pointed out that the revenue cap is only one criterion to be considered, as the city should also consider is the scope of these organizations, the services and needs they provide and are used by residents.
It should be noted that any additional action taken by the city council would add to the city's budget deficit, so approving three months of rent forgiveness for the 68 tenants would cost the city about $875,000, according to staff.
While limiting aid to the 58 tenants who have had to stop operations during the pandemic would add 751,000 to the revenue shortfall.
The measures to get support for the nonprofits include deferring infrastructure projects for several city parks and repairing some streets. The request came exactly one month after the council approved a construction contract for a public safety building expected to cost $118 million.
After a nearly 12-year battle where the Cargill Salt Company sought to develop and expand its property in the San Francisco Bay Area near the port of Redwood City, the U.S. Environmental Protection Agency withdrew Friday an appeal made during the previous federal administration, concluding that the area is subject to the federal Clean Water Act.
The potential expansion meant billions of dollars in business for Cargill, a private Minnesota-based company that evaporates water on the 1,365-acre property in "crystallizer beds" to produce salt for industrial uses.
However, the land, being subject to the 1972 Clean Water Act, sharply limits what can be built in the area, a ruling that environmentalists widely applauded, saying for years that the land, which is at sea level and was once part of San Francisco Bay before it was leveed in 1902, should be restored as tidal wetlands for fish, wildlife and recreation.
They also argued that any attempt to develop the land in front of the bay is impractical due to sea level rise.
"We're thrilled that President Joe Biden's administration is doing what Trump didn't, which is upholding the law and protecting clean water, wetlands and the Bay," said David Lewis, executive director of Save the Bay, an Oakland-based environmental group.
At the same time, he detailed that there was always broad and deep opposition in the Bay Area to building on the property, yet Cargill had found a friend in the Trump administration.
According to the salina's attorneys, the property is dry land separate from the bay and is not subject to the Clean Water Act, which requires a federal permit to fill "waters of the United States."
In light of this, Cargill will not give up on its attempt to make the extension, as it says it plans to move forward with an appeal in the U.S. Ninth Circuit Court of Appeals.
"Our focus has always been to protect environmental resources and work with our neighbors in the Bay Area to consider future uses of the site," David Smith, an attorney for Cargill and DMB Pacific Ventures, an Arizona company that has sought to develop the property, said at the time.
During 2009, Cargill and DMB proposed to build 12,000 homes on the industrial salt production land along Seaport Boulevard north of the Dumbarton Bridge, a project that would have become the largest development on the San Francisco Bay shores since Foster City was built in the 1960s.
But, again, the project was withdrawn in 2012 amid opposition from community groups and environmentalists.
Cargill does not remove the finger from the line and maintains that it seeks to advance in Otero project, however, has not offered details.
We should remember that, in 2016, during the Barack Obama administration, the Army Corps of Engineers ruled that Cargill's property was not subject to the Clean Water Act, yet the U.S. Environmental Protection Agency (EPA) in San Francisco came to the opposite conclusion. And under federal law, the EPA can override the Army Corps in special circumstances.
The issue fell by the wayside, and along came the Trump administration, which took it upon itself to give the saltworks an open letter, signing a letter concluding that the property "is not subject" to the Clean Water Act's development restrictions. Environmentalists did not sit idly by and filed a lawsuit to challenge the decision.
With the Biden administration, things changed again, as it appears that the environment will be a priority, as U.S. District Court Judge William Alsup, in relief of environmentalists' arguments, ruled that the area is still connected to the bay by tide gates and intake pipes, and most importantly, it's wet.
EPA halts Cargill salt plant, prevents expansion of Redwood City facility, EPA withdraws appeal from past administration.
It should be noted that the matter is not over, and there will be more legal problems, as the environmental groups sued the EPA, not Cargill, and the appeals court will have to decide whether the salt plant still has standing in the case to continue with the appeal of the lower court's decision.
On March 2, 2020, children from all over San Mateo County came together to enjoy "Read Across America Day."
In the presidential race, Vice President Joe Biden had just won his first primary.
Local news headlines said a sold-out crowd of 18,064 watched the injury-plagued Golden State Warriors lose by 14 at home last night.
Students at high schools in Burlingame, Redwood City and Half Moon Bay, meanwhile, held weekend sports championships.
And everyone enjoyed a pleasant 70 degrees from Daly City to Half Moon Bay to San Mateo. All in all, a good late winter day.
San Mateo takes stock one year after COVID-19 pandemic. The Health Department reported the first known local case of COVID-19.
"That was the turning point where it changed life as we knew it. At the time, we didn't know how profound those changes would be," said county administrator Mike Callagy, who also serves as countywide emergency services chief.
"This is a moment we will all remember because since then we have all been challenged like never before in most of our lives," he added.
The county laid the groundwork for activation of the Emergency Operations Center -EOCThe county health department detected the threat of COVID-19 and activated its own Department Operations Center when SARS-CoV-2 arrived in the U.S. in January. The County Health Department detected the threat of COVID-19 and activated its own Department Operations Center when SARS-CoV-2 arrived in the U.S. in January.
At the time, the county indicated through a statement that the first few days of the EOC activation there would be physical distancing, but no need for masks. Still.
Also, providing food to those in need of isolation was and remains a high priority.
It was recalled that "The Mask Mobile" has distributed more than 26,920 masks across the county since it was first launched last year.
It was also noted that San Mateo County Health is actively working through the various phases of distribution as quickly as possible to direct the limited supply of vaccine to the identified priority groups.
In that vein, San Mateo County has launched a "Come Back" campaign to unite residents and remind them of "all the steps we need to take to stay safe."
Then, the county increased the EOC's planning functions and staffing to prepare for activation on March 2, 2020, when its operations would run 24 hours a day, 7 days a week.
"The Emergency Operations Center is the heart and soul of our community's response to COVID-19," said David J. Canepa, chairman of the San Mateo County Board of Supervisors and chairman of the county's Emergency Services Council.
Since the pandemic began, the EOC has led the response through timely and accurate communications to the public and by organizing, coordinating and delivering vital services to the community. This includes $97 million in direct assistance to individuals, families, small businesses and community-serving organizations, the county said.
As compiled by the San Mateo Recovery Initiative, the county has provided:
16.05 million to 4,269 individuals and families
11 million to 657 small businesses
38.56 billion to nonprofits that serve the community
4 million to Second Harvest Food Bank to help provide food for residents
1,208 people served in supportive housing for isolation and quarantine (Alternative Housing Sites), along with tiered medical support (Alternative Care Site).
Approximately 1.5 million meals for vulnerable residents through Great Plates Delivered program
The COVID-19 Pandemic in San Mateo County by the Numbers:
Total number of people vaccinated: 157 thousand 337
People who completed the vaccine series with two doses: 61,621
Total number of vaccine doses in the arm: 218,958
Total number of COVID-19 cases: 38,865
Total deaths related to COVID-19: 521
As of this Monday, March 1, the EOC is integrated into the County's Regional Operations Center -ROC, a $64.5 million, two-story building in downtown Redwood City, which opened in late 2019.
The ROC also includes the Public Utilities Safety Communications 9-1-1 system and the daily offices of the San Mateo County Area Office of Emergency Services.
In addition, the Strong San Mateo County Fund, a public-private initiative that raises funds to help individuals, small businesses and non-profit groups that are experiencing financial hardship due to the pandemic, was created.
The following information is the result of research conducted by a team of journalists, members of the Diploma in Data Journalism and Investigative Techniques -focused on organized crime-, which was given by the Carlos Septién García School of Journalism in Mexico City.
Child exploitation is a form of organized crime that profits from the recruitment and sexual abuse of children and adolescents on various digital platforms, especially social networks.
Often, the person behind a profile is not a person, but an "impressive child pornography" network. It all starts by asking for a photograph of the child to blackmail the family.
"If you don't give me a certain amount of money, I'll show the photo or do something to your child," said María Isabel Christensen, head of Research and Prevention at the NGO Mamá en Línea, an organization based in Argentina, dedicated to prevention and training to combat drug trafficking. grooming and online bullying.
The COVID-19 pandemic exacerbated the systemic economic and social inequalities that are among the underlying causes of the crime of trafficking in persons.
The risk of being a victim of these crimes increases just as much for teens who begin to practice sexting -The practice of sending messages, photos or videos with erotic and personal sexual content via mobile phone - a practice that continues to grow during the quarantine period.
The sale of child abuse and exploitation material makes a lot of money, so much so that it is one of the three most lucrative activities for criminal organizations after drugs and arms trafficking.
How do pornography groups operate?
These organizations and groups also create the didactics of getting what each consumer wants, according to their tastes: the selection of a victim by age, characteristic, skin tone, etc., gives rise to other crimes such as human trafficking and kidnapping.
One of the main strategies of perpetrators and criminal organizations is to simulate an identity different from their own. Usually, they pretend to have the same age, tastes and preferences as the victims they have selected. Even an innocent photo next to a door, park or any location gives them enough material to study in detail their victim, who naively continues to upload material ignoring the intentions behind every sexual predator surfing the Internet.
"The moment the mother or father is distracted, the pedophile captures the attention of that child, attracts him and that's when they take them. What does he do first? He sits in front of the computer and knows where to find minors on social networks like Facebook, Instagram or the most popular among young people. He searches for minors or goes to the profiles that are open, checks the pictures. It may be the profile of an adult. Most of them have their children in the profiles, there he goes looking and realizes that he has a daughter, for example. So he searches and selects information about when he tagged her, he already has a piece of information. In another photograph, she finds the girl celebrating her birthday, she has another piece of information, which is her age. Then, the aunt uploads another photo of the girl leaving school and adds another piece of information and she already knows the school she goes to. Once she has the information and the photographs, she creates a profile of another girl that relates her to that girl and she already has her possible victim and that's when she starts to manipulate her to contact her: "Hello, what's your name", and ask her questions to build trust," explained María Isabel.
Recruitment or the search for potential victims has been facilitated, among other things, because both children and adolescents have Internet classes that lead them to be connected to a type of messaging, which allows social interaction - chat rooms, TikTok, Facebook, Instagram, etc. -.
"That's where the criminals go to try to recruit, to seduce. The common criterion is that they are usually kids who are looking for attention. Some are not well at home, they have no communication with their parents and are looking for attention, affection because they are alone," he said.
"The victims take videos of themselves in bathing suits, behind their house, they announce where they are going, the location, where they have been (...) That's when the perpetrator can know their location, there is the danger because they will reach them and they will contact them," said Soto, who is part of a community of hackers, who work hand in hand with the law and the support of the authorities to prevent cybercrime in the United States.
Open chat rooms, a source of danger
Child predators are also active on the most popular online video game platforms or on anime sites. In these spaces, communities can be recreated to generate interaction, using techniques such as the grooming -pedophile deception-:
"I, an adult of a certain age, pretend to be another child, but, in addition, I've been listening to him in video games, I know what day he connects, at what time; I've heard what he talks about, because he does it over the Internet. And many times the victims can share information, for example: "I'm alone", "my mom went to work as a nurse", "my dad is not here either". Finally, these conversations make a profile of the child with whom the aggressor generates that bond of trust, several days pass until trust is achieved with expressions like: "I know you can't go to the next level", "I'll help you", "I can give you advice" and the child believes that he is a friend, that he is a good person and that he is six years old like him", the risks for children and adolescents rise when parents stop supervising the activities of their children both in social networks and when they play online with chats, where they connect with strangers.
"The pedophile searches on Google and knows what are the most popular games, he starts searching in those games and once he gets in as a user he selects the minor. He throws a bait with something that children like a lot to look for the one who can violate. When they already have the victim, they invite the child to private places such as WhatsApp, where the adult is already alone with the child".
Online games include those based on anime and manga (a Japanese comic book genre). Some of them include rules where the youngsters must play roles that the adult can access and manipulate. Players must do everything they are ordered to do as if they were a kind of teacher and where the aim is to sexualize the minor.
The experts consulted in this research emphasize that all social networks with chat are synonymous with contact and, therefore, danger for children and adolescents.
"Everything that allows that child to interact means a risk (...) a pedophile with a chat room has more chances of finding a minor, because they are open, no one is watching and the child does not differentiate what is a contact from a friend or a criminal," said the member of the organization Mamá en Línea.
Gateway to human trafficking
The link between the abuse and exploitation of children and adolescents and organized crime includes the dark chapter of kidnapping, human trafficking and trafficking of children under 18 years of age who may be contacted through a comment, videos, music or chats through which sexual predators navigate with the purpose, later, of trying to take the victims.
Children and adolescents continue to be at high risk of exploitation, especially with the closure of schools that not only hindered access to education, but also took away a source of refuge for victims who were once more likely to come forward and report an abusive situation for help, but which has now been lost due to the global quarantine.
Governor Gavin Newsom, Senate President Pro Tempore Toni G. Atkins and Assembly Speaker Anthony Rendon announced an agreement Monday on a $6.6 billion budget package to accelerate the safe return to face-to-face classes across California and empower schools to immediately expand academic and mental health and social-emotional support, including during the summer.
"Now, our collective responsibility is to build on that momentum and local leadership and, equally critically, to do whatever it takes to meet the academic and mental health needs of our students, including during the summer," Newsom said.
The state's fifth-largest public school district was among the first to close for in-person instruction last year. But last week, based on a deep partnership between school staff and leaders, the district announced plans to reopen grades K-6 in mid-March and grades 7-12 in early April.
Elk Grove Unified and public schools statewide will receive $6.6 billion under the proposed budget package.
In that regard, $2 billion would fund safety measures to support in-person instruction, such as personal protective equipment, ventilation upgrades, and COVID-19 testing.
While $4.6 billion would fund expanded learning opportunities, such as summer school, tutoring, and mental health services.
Officials said all public schools would be required to offer in-person instruction for grades K-2 to all students and for all high-needs students in all grades by the end of the month, losing 1 percent of eligible funds every day thereafter if they fail to do so.
In addition, schools at "Level Red" or below would be required to offer in-person instruction to all students in all elementary grades and at least one middle or high school grade, or face the same risk of the above sanction.
As students return to face-to-face instruction, all public schools will also be empowered to meet the needs of the whole child.
Expanded Learning Opportunity Grants allocate $4.6 billion to local educational agencies under the equity-based Local Control Funding Formula, with an additional $1,000 per homeless student.
These funds would be for supplemental instruction and social and emotional wellness support.
Schools could use the funds to provide more instructional time, such as summer school, and accelerate progress in closing learning gaps through tutoring, remedial learning programs, mental health services, access to school meal programs, programs to address student trauma and social issues.
As well as for emotional learning and supports for credit deficient students and more.
The package would also codify multiple successful state programs to support the safe reopening of schools, such as prioritizing vaccinations for K-12 school staff.
Thus, the package codifies the governor's commitment to set aside 10 percent of vaccines for education workers.
This commitment ensures that the statewide prioritization of school staffing, in effect since January, becomes a reality in all 58 counties.
It will also help generate a data report for schools to report reopening status and COVID-19 safety measures. These legal requirements will help leverage efforts to increase transparency, including interactive geospatial maps displayed on Safe Schools Hub.
The package also appropriates $25 million for the state's Safe Schools Team, which serves to provide technical assistance, oversight, and accountability to California's more than 10,000 public schools.
Perhaps, one day literature will disappear and it will do so when communication through words is no longer necessary, when there are machines that can transmit thought.
It seems incredible, but since the 19th century, and thanks to the case of Phineas P. Gage (1823-1860) - who was pierced by an iron bar that went through his cheek, came out of his forehead and miraculously survived - neuroscience acquired the dimensions in which it is today because, by studying that case, it became clear that parts of the brain could be analyzed in order to find the specific places where sensations such as love, religion, God, fears, happiness, etc. are stored.
The BRAIN initiative of 2013 set out to map the brains of human beings. Neuron by neuron. An unprecedented effort that could result in knowing if something hurts a person mentally, find it physically and change it through drugs or therapies.
From this perspective, the aim has been to relate people's thoughts and decode them so that they can be translated into mechanical movements. Since the year 2000, there have been results in this area that have given serious hope for the feasibility of a machine being able to transmit what we think. If we can send what we think, will it be necessary to speak? The answer is an unknown that the future of science will elucidate. In the meantime, in that uncertain future for literature and speech itself, these are arbitrary recommendations for reading in 2021, as the end of writing arrives:
6. The great friendby Elena Ferrante. DeBolsillo.
Elena Ferrante has raised a whole search around her. They don't know for sure who she is. It has been presumed that it is in fact her husband Domenecio Starnone who writes her novels - an obviously sexist view - but Claudio Catti's research has revealed that she is the freelance translator Anita Raja, the daughter of a German mother who escaped the Holocaust and a Neapolitan judge.
Another element that led us to suspect her is that Raja works for Edizioni, the publishing house in charge of publishing Ferrante in her native Italy and that, after the worldwide success of this novel, the translator's income increased tenfold. In reality, we don't really care who this celebrated writer is, what is really worthwhile is her prose, the depth of the situations in which her characters, mainly two women, and the way in which their friendship develops in an Italy that suffered greatly after the post-war period.
The vicissitudes that they go through since their childhood and that, as the tetralogy progresses, increase the level of demand on the reader who goes from situations - to call them in a way - easy to more complex circumstances.
7. The friendby Singrid Nunez. Anagrama.
The friend by Nunez, is a work that unfolds after the death of a teacher, who is also a friend and possible lover of the writer, who achieves a novel without the greatest of setbacks.
The novel works as an essay on literature itself, but it also works as a very personal story in which the characters do not need a great presence, but rely on the discourse of its narrator who goes into the context of her life in a little more than brilliant way and launches different links where she catches the passage of the dogs in literature and the function of the writers or characters of them. All these relationships, apparently irrelevant, take on a different and, in many cases, decisive connotation to give a new contour to that inner voice that continues to grow until it encompasses the whole story.
Ingrid Nunez was once the mother-in-law of the late Susan Sontang and this is relevant because of some similarities that exist between the two, especially the essayistic, lucid and concrete tone of her narratives.
8. Lincoln in the Bardoby George Sunders. Seix Barrial
Master of short stories, George Sunders surprised both friends and strangers with this novel that is a historical journey through the life of one of the most important men in the history of the United States: Abraham Lincoln, where he looks at a decisive moment in the course of his life: the death of his young son.
The novel is a journey through this moment where a series of choruses appear and lead the scene through multitudes of dark and light places where spirits interact with the characters.
The paragraphs are brief, concise and beautiful in their economy, but not because of what they describe - which have to do with very deep areas of reflections on life, death, friendship, honor and, in itself, the meaning of the decisions that are made or not - but because of the economy of his words that, with little, say a lot. A story full of rich experimentation without it feeling like an element of unfamiliarity, Sanders shows us that great literature can also be a brief score.
9. Sapiens: From Animals to Godsby Yuval Noah Harari. Debate.
One of the sins that the Hebrew philosopher Yuval Noah Harari commits in this book is, perhaps, to believe that mankind will get rid of all its evils by the same force in which the market has delivered its evils during its history; However, the deployment of knowledge that he makes about the historical facts and the way in which he uses them to prove his hypotheses, makes his account of the history of humanity a historical line that, homogeneously, has served to note how the intelligence of mankind has been imposing itself and, uninterruptedly, has overcome the obstacles that disparity and selfishness have imposed on it.
For Yuval, all conflagrations have been due to humanity's lack of integration, its lack of collaboration and its primitive state in which even nations look out for their own interests and interpose their sovereignties to the idea that, inexorably, will come where the world will be one big village.
10. Ragtimeby E. L. Doctorrow. Grijalvo.
Ragtime is, shall we say, the father of Jazz or at least a rhythm that precedes it, this novel is set in the early 20th century and is, in another way, a Forrest Gump style novel where a character, in this case an entire family, intersects with the history of the United States and the intersection of characters like escapist Harry Haudini, revolutionary Emiliano Zapata, banker P. J. Morgan or feminist and social fighter Emma Goldman.
They interact with various characters who are otherwise an archetype that the writer deploys to serve as a backdrop against which the story and the narrative itself move at a dizzying pace.
Within its pages, the turn of the century in the United States is seen as a series of events that take on relevance and congruence thanks to the mastery with which Doctorrow makes the fictional and the non-fictional amalgamate. Doctorrow is one of the most gifted writers in the United States who, nevertheless, have not achieved fame. In keeping with the enormous quality he demonstrates, he may be largely forgotten, but not one to lose his vigor with the passage of time.
Epilogue
Perhaps, one day literature will disappear, as will painting and all the other fine arts, replaced by robots and, however technology threatens, art will still be there.
Even if it is a machine or a program that initiates a stroke or composes a song, the human element will still be present in some form.
At the beginning of the last century, it was thought that, with the invention of the cinematograph, other arts would perish and it was not so; instead, there was an enrichment where all the fine arts could be enriched. Technology is not a fatal destiny where everything homogeneous will be lost; it is, instead, an opportunity to experiment with what is new, with what does not exist and always offers us the opportunity to reinvent ourselves.
After one of the most difficult years of our lives, there is light at the end of the tunnel - the COVID-19 vaccines are here, and my government is working to make sure that no community is left behind.
COVID-19 vaccines are safe and effective. They are our best hope for ending the pandemic. Getting a COVID-19 vaccine is free, even if you are undocumented or uninsured.
After the federal government licensed the vaccines last December, our own Western States Scientific Safety Assessment Panel confirmed that the vaccines are safe. The Panel includes nationally recognized scientists, many from California, with expertise in public health.
While vaccine stocks are low at the moment, we are working closely with the federal government to get more vaccine to the state. And we are working hard to build a system to quickly and safely vaccinate Californians with equity at the forefront.
Because vaccine supply is limited, we are prioritizing vaccines for Californians most at risk - including health care workers, people over 65, education and child care workers, and emergency services and food and agriculture workers. That means supermarket workers, farm workers, those who work in food processing facilities and many others can now be prioritized. And we're doing what we can to make sure that the communities most impacted by COVID-19 - which are often communities of color and the essential workers who have been sustaining us during this crisis - can access the vaccine.
We are investing in community-based organizations and partnering with trusted messengers who have been providing critical services and information to California's diverse communities throughout the pandemic so they can help educate, motivate and activate people to get vaccinated when it's their turn. We are also building messaging through a public education campaign, creating in-language content with cultural humility, and meeting Californians where they are - literally, through mobile vaccination sites that have been deployed across the state to community centers, places of worship, and health clinics.
Vaccination sites are being established across the state, and we are working closely with community partners to ensure that vaccines are distributed to those who have been most affected by this virus.
You may see people in uniform or police guarding vaccination sites. They are here to help Californians get vaccinated and to help them no are immigration authorities.
The federal government, under President Biden, has confirmed that no will conduct immigration enforcement operations at or near vaccination sites or clinics. You should not be asked about your immigration status when you receive a COVID-19 vaccination.
Also, your medical information is private and cannot be shared with immigration authorities. And vaccinations do not count under the public charge rules.
All Californians can register at myturn.ca.gov to be notified when they are eligible for an immunization. Eligible individuals in several counties, including Los Angeles, San Diego, Fresno, and San Francisco, can also use My Turn to schedule an appointment, and it is expected that more counties will begin using My Turn for scheduling in the coming weeks. My Turn can also be accessed through a toll-free hotline at 1-833-422-4255. Operators speak English and Spanish, and third-party interpretation is also available in more than 250 languages. You can also ask your doctor or pharmacy about scheduling a vaccination appointment.
After getting vaccinated, it will still be important to wear a mask, wash your hands frequently, and continue to maintain a six-foot distance to protect those in your community who have not yet been vaccinated.
I encourage all Californians to get vaccinated when it's their turn. Together we can end the pandemic.
The U.S. Food and Drug AdministrationFDAJanssen's COVID-19 vaccine, manufactured by Johnson & Johnson Pharmaceuticals, was approved Saturday on an emergency basis and can be given to people 18 and older.
This vaccine is the first single-dose immunization vaccine to be licensed by the U.S. government to counter the SARS-CoV-2 epidemic.
The statement issued by the FDA said that Janssen's vaccine meets the legal criteria for use in the country.
"The totality of available data provides clear evidence that Janssen's COVID-19 vaccine can be effective in preventing the disease," the agency reported.
Acting FDA Commissioner Janet Woodcock noted that the licensing of this vaccine expands the availability of vaccines, "the best method of medical prevention for COVID-19, to help us in the fight against this pandemic, which has claimed more than half a million lives in the United States.
The trial for the Janssen vaccine involved 44,000 people, and found the vaccine to be 66 percent effective in preventing moderate to severe COVID-19 four weeks after inoculation, and 100 percent effective in preventing hospitalization and death from the virus.
The document also details that there are very few serious side effects from the vaccine, and shows preliminary evidence that immunization reduced asymptomatic infections. However, more data from the vaccine is awaited, as according to the FDA there is no data on how long the vaccine's protection lasts.
It should be noted that the distribution and storage of this vaccine is much more effective and safer when using a normal refrigeration system, unlike the immunizations made by Pfizer/BioNTech and Moderna, which must be transported and stored in special conditions at temperatures below 70 degrees Celsius.
The U.S. government, which has purchased 100 million doses of Johnson & Johnson vaccine, plans to distribute about 4 million doses this week.
This would be in addition to the approximately 16 million doses of Pfizer/BioNTech and Moderna vaccines that are expected to be distributed throughout the United States.
For his part, President Joseph Biden said, "This is exciting news for all Americans, and it will encourage developments in our efforts to end the crisis. But I want to be clear: this fight is far from over. While we celebrate this news today, he called on all Americans to continue to wash their hands, keep their social distance, and keep wearing masks.
"There is a light at the end of the tunnel, but we cannot let our guard down now or assume that victory is inevitable. We must remain vigilant, act quickly and aggressively and look out for each other, that's how we will reach that light together," he said in his statement.
Johnson & Johnson's vaccine joins Pfizer/BioNtech and Moderna's biologics, both of which have two applications.
U.S. President Joseph Biden and his Mexican counterpart Andres Manuel Lopez Obrador are scheduled to meet on March 1, where they will discuss various issues involving both nations.
The meeting will be part of the follow-up to the various talks between the leaders, said the Mexican Foreign Ministry in a brief statement.
Likewise, the Ministry of Foreign Affairs -SER- noted that Presidents Lopez Obrador and Biden will discuss the shared vision and objectives of the bilateral agenda.
In the virtual meeting, both presidents will give special attention to address cooperation mechanisms to address the structural causes of migration in northern Central America and southern Mexico.
In addition, they will discuss the ravages of COVID-19 and the areas of opportunity presented by the T-MEC towards a sustainable and more equitable economic recovery in North America.
It is recalled that the first time that Andres Manuel Lopez Obrador and Joseph Biden engaged in a conversation was on December 19, 2020, after the U.S. president was recognized by the U.S. Congress as the president of the United States.
Subsequently, on January 22 of this year, the presidents held another conversation, in which Lopez Obrador stressed that the dialogue was "friendly and respectful".
"We discussed issues related to migration, COVID-19 and cooperation for development and welfare. Everything indicates that relations will be good for the good of our peoples and nations," said the Mexican president through his Twitter account.
Pfizer and BioNTech announced Thursday that they have initiated an evaluation of the safety and ability of their antigen to activate the immune system and induce an immune response - immunogenicity - with a third dose of their COVID-19 vaccine, following strong concerns about variants of the SARS-CoV-2 virus.
In a statement, Pfizer said that these tests "will serve to understand the effect of a boost in immunity against COVID-19 caused by circulating and potential emerging variants".
The study will be based on U.S. Phase 1 study participants who will be offered the opportunity to receive a 30-microgram booster of the current vaccine 6 to 12 months after receiving their initial two-dose regimen.
The study is part of the companies' clinical development strategy to determine the efficacy of a third dose against evolving variants.
Separately, in order to be prepared for any potential future strain changes, Pfizer and BioNTech are in discussions with regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, regarding a clinical study to allow registration to evaluate a variant-specific vaccine that has a modified mRNA sequence.
This study would use a new Pfizer-BioNTech vaccine construct based on the B.1.351 lineage, first identified in South Africa.
With such studies, the company could quickly update the current vaccine if the need arises to protect against COVID-19 from circulating strains.
Thus, in accordance with the updated guidance issued by the FDA regarding the emergency use of vaccines to prevent COVID-19, which provides recommendations for evaluating a modified vaccine to address variants, the companies expect to continue validation of future modified mRNA vaccines with a regulatory pathway similar to that which currently exists for influenza vaccines.
"While we have not seen any evidence that circulating variants result in a loss of the protection provided by our vaccine, we are taking multiple steps to act decisively and be ready should a strain become resistant to the protection provided by the vaccine. This booster study is critical to understanding the safety of a third dose and immunity against circulating strains," said Albert Bourla, president and CEO of Pfizer.
The executive added that, at the same time, it is making the right investments and engaging in the necessary discussions with regulators to help it position, develop and seek licensing for an updated mRNA vaccine or a booster if needed.
"Our proactive clinical development strategy aims to create the foundation today, which will enable us to address tomorrow's challenges. We want to be prepared for different scenarios," said Ugur Sahin, CEO and co-founder of BioNTech.
"We will therefore evaluate a second booster in the current regimen and prepare for a possible rapid adaptation of the vaccine to address new variants that might escape the current version of our mRNA-based vaccine," he stressed.
In that regard, he noted that the flexibility of their proprietary mRNA vaccine platform allows them to technically develop booster vaccines within weeks, if needed.
This study will evaluate up to 144 Phase 1 participants in two age cohorts, 18-55 and 65-85 years. The study will include trial participants who received both doses in the Phase 1 study 6 to 12 months ago to assess the boosting ability of BNT162b2.
Therefore, the study will assess the safety and tolerability of a third vaccine regardless of the trial participant's level of antibody titers. Participants will be evaluated at the time they receive the third dose, then one week and one month later, and Pfizer and BioNTech plan to study the ability of those participants' sera to neutralize the SARS-CoV-2 strains of interest.
Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the FDA, but has been cleared for emergency use by the FDA, under a license, to prevent COVID-19 disease for use in people 16 years of age and older.
