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I did not know that Cuba developed a COVID vaccine. Interesting...

Inside Cuba's race to vaccine sovereignty
https://www.cnn.com/2021/03/31/americas/cuba-vaccines-covid-phase-three-intl-latam/index.html

The sign on the door was written by hand and the lights were turned off to save electricity, but inside the clinic Cuban doctors were administering what they say is a cutting-edge vaccine against the coronavirus.

Despite a worsening economy and increased US sanctions, the communist-run island has pulled off a feat no other Latin American country can claim to date: the development of five Covid-19 vaccine candidates, two of which that are in their final phase three trials.

As the number of coronavirus cases on the island continue to rise, its vaccine candidates and the island's aspirations to be a biomedical powerhouse will be put to the test. On Wednesday, Cuba hit a grim new record in Covid-19 infections -- 1,051 new cases diagnosed in 24 hours.

Cuban officials in March announced they were expanding the vaccine trials already underway to include hundreds of thousands more people. First up in the expanded trials are 150,000 front line workers, including Ida Martínez Hernández, a dentist who early on in the pandemic was sent by the government to help fight the spread of the virus.

"We have been working this whole time. In testing, at the airport, in isolation centers. We are people who are at high risk, this will give us more protection," Martínez told CNN as she received her first shot of Cuba's home-grown Soberana-02 vaccine, which means "sovereign" in Spanish.

In times of crisis, the Cuban government has often marshaled its people to carry out seemingly quixotic undertakings, from attempting to cut a record sugar cane harvest to massive demonstrations demanding the return of Elían González.

Now, at the same time Cuba endures shortages of food and basic medicines, the island's government has set its sights on developing the kind of sophisticated Covid-19 vaccines that have eluded far richer countries.

While the results of the final trials for the two most advanced vaccines are not expected for months, already some in the island are taking an early victory lap. A slickly produced video tweeted out by Cuban President Miguel Díaz-Canel proclaimed that that Cubans were producing "more than a vaccine, it's a country."

The superstar Cuban musical duo Buena Fe penneda song about the vaccines, crooning the drugs were like "brave David confronting the bully Goliath."

Chest thumping and politics aside, some researchers say that Cuba's approach of making their own vaccines that could go in the arms of every Cuban and millions of others across the region is badly needed right now.

"Latin America unfortunately lacks some of this ecosystem of being self-sufficient and Cuba is ideal because they have their own production capacity and they also are very well recognized and have a good reputation," said Dr. Maria Elena Bottazzi, the associate dean of the National School of Tropical Medicine at the Baylor College of Medicine in Houston.

Long cut off from much of the rest of the world, Cuba for decades has made many of the medicines the island needs and increasingly exports Cuban-made vaccines abroad. When the pandemic hit, Cuba was one of the few developing countries that was well positioned to produce their own vaccines.

Other countries, particularly those that can't afford the vaccine -- or for political reasons don't want to accept vaccines from Western countries -- are hoping Cuba's promised cheap and easy to store vaccines can make up the difference.

Iran, where the Supreme Leader Ayatollah Ali Khamanei banned the use of American and British vaccines, is currently carrying out large-scale trials with 100,000 doses of Soberana-02 and could begin producing the Cuban vaccines in the Islamic Republic.

In March, Cuba announced it was sending 30,000 doses of the Soberana-02 and Abdala vaccine candidates to socialist ally Venezuela and that Cuban and Chinese scientists would co-develop a new vaccine against emerging strains of the coronavirus.

Cuba has gambled their entire response to the pandemic on making their own homegrown vaccines and now the island is doubling down on that bet by vastly expanding the testing of those drugs.

In March, Cuban officials said wider interventional trials would include the entire adult population of Havana, nearly two million people, and the epicenter of the virus on the island. By August, half the island's population, about six million, would receive the vaccines officials said.

But moving so quickly to mass vaccination is a risky strategy that could backfire if the vaccine candidates prove be less effective than what Cuban scientists predicted. While previous testing showed the vaccines' safety, Cuban researchers have yet to determine exactly how well the vaccines will work.

"The Cuban vaccines haven't even completed the plan of vaccination for volunteers in phase three and we don't know their efficacy," wrote in a Facebook posting Amílcar Pérez Riverol, a former University of Havana professor of Microbiology and Virology, who closely follows Cuba's vaccine efforts.

But at a Havana clinic, where doctors and nurses are administering about 100 doses of Soberana-02 to frontline workers each day, administrators said they had observed no serious side effects during the expanded trials and were positive the increased vaccination would help turn the tide of the pandemic on the island.

"We are all convinced," said nurse Norma Olivares, "The vaccine works and the vaccine gives immunity."

More news about the Cuba vaccine...

Cuba says it's 'betting it safe' with its own Covid vaccine
“We are seeing a safety profile with the vaccine [Soberana 2] that is very good," Dr. Vicente Verez, director of the Finlay Institute of Vaccines, told NBC News.
https://www.nbcnews.com/news/latino/cuba-says-betting-safe-covid-vaccine-rcna643

HAVANA — Cuba is "betting it safe" with the later development of their own Covid-19 vaccines and encouraged by what they're seeing in late stage and experimental studies, a top Cuban vaccine scientist said.

If the trials are successful, the relatively small, communist island of 11 million — that has been sanctioned by the United States for decades — would be one of just very few countries with vaccines to fight the coronavirus pandemic, drawing worldwide attention to its potential feat.

The other countries that have developed vaccines, including the United States, the United Kingdom, China, Russia and India, have significantly larger economies and population sizes.

Two of Cuba’s five vaccine candidates are in Phase 3 trials: Soberana 2, which translates to 'sovereignty,' and Abdala, named after a book by the Cuban independence hero José Martí.

Around 44,000 people are getting the Soberana 2 vaccine as part of the Phase 3 double-blind study. An additional 150,000 health care workers are being inoculated with Soberana 2 as part of an “interventional study.”

The Cuba experimental vaccine is similar to the Novavax vaccine being developed in the U.S. Unlike the mRNA vaccines from Pfizer-BioNTech and Moderna, the Soberana 2 uses synthesized coronavirus proteins to trigger the body's immune system.

“We are seeing that the vaccine is very safe, the potential risk for applying it to more people is decreasing, and the potential benefits are increasing. There is evidence of certain efficacy and that is why we decided to expand the interventional studies,” Dr. Vicente Verez, director of the Finlay Institute of Vaccines, told NBC News. The institute is named after the Cuban epidemiologist Dr. Carlos Finlay who discovered yellow fever is transmitted through mosquitoes.

The institute was established in 1991 by the late Cuban leader Fidel Castro who invested heavily in the country’s health care system and pharmaceutical sector. Its cancer research center developed a vaccine being tested in the United States and other countries.

In Cuba, “we began a bit later than the rest of the vaccines [in the world] because we had to wait and know a little more about the virus and the mechanism though which it infects cells,” Verez said. “We are seeing a safety profile with the vaccine [Soberana 2] that is very good.”

With its economy ravaged by the pandemic, decades of sanctions and a decline in aid from its ally Venezuela, the island has been grappling with shortages in food and medicine. Its economy shrank 11 percent in 2020. But it has managed to keep the number of Covid-19 infections and deaths down with strict measures and lockdowns, compared to many developed countries around the world. In recent weeks, the country has averaged around 1,000 cases per day, but it had very low infection rates last year.

The final results of the Phase 3 trials are not expected for months. The government’s plan is to have nearly all the inhabitants of the capital, Havana, vaccinated by May through the interventional study, and the entire country’s population inoculated before the year ends.

Verez said that while the vaccination won’t be mandatory, he thinks “the immense majority of the population wants the vaccine.”

For Cuba, the vaccine is as much about public health as it is a show of force; that a small communist country sanctioned by the U.S. can compete on the world stage with its own vaccine candidates.

Cuba could have acquired vaccines from its allies, China and Russia, but developing its own gives it the opportunity to sell vaccines to underdeveloped countries that have seen few doses, giving it a source of badly-needed hard currency. As U.S. and British vaccines advanced in clinical trials last year, wealthy countries in North America and Europe preordered large quantities, leaving poor and developing countries with a large gap in access.

Verez said some countries have approached Cuban officials with the intent to purchase more than 100 million annual doses of some of its vaccines. He said Cuba’s vaccine production system is being reorganized to produce 100 million doses.

Iran, which banned U.S. and British vaccines, will host a Phase 3 trial of Soberana 2 as part of an agreement that includes producing millions of doses there. Venezuela will produce Abdala vaccines, its government announced Thursday. Mexico and Argentina have also expressed interest in Cuba’s vaccines.

“They are very safe,” Dr. Eduardo Martínez Díaz, president of the state-run BioCubaFarma, said in emailed responses to questions. “After applying thousands of doses, only slight and moderate side effects were seen in a small percentage of volunteers.”

Díaz added that both vaccines are creating a high amount of immunity. If exported, the prices would be affordable, he said.

Verez said the vaccines will be adapted to the new variants, and extra doses could be required to boost immunity.
 
CDC real-world study confirms protective benefits of mRNA COVID-19 vaccines
https://www.bowmanextra.com/communi...cle_1cf9af84-98fd-11eb-94e1-cbb476d91d56.html

A new CDC study provides strong evidence that mRNA COVID-19 vaccines are highly effective in preventing SARS-CoV-2 infections in real-world conditions among health care personnel, first responders, and other essential workers. These groups are more likely than the general population to be exposed to the virus because of their occupations.

The study looked at the effectiveness of Pfizer-BioNTech and Moderna mRNA vaccines in preventing SARS-CoV-2 infections among 3,950 study participants in six states over a 13-week period from December 14, 2020 to March 13, 2021.

Results showed that following the second dose of vaccine (the recommended number of doses), risk of infection was reduced by 90 percent two or more weeks after vaccination. Following a single dose of either vaccine, the participants’ risk of infection with SARS-CoV-2 was reduced by 80 percent two or more weeks after vaccination.

It takes about two weeks following each dose of vaccine for the body to produce antibodies that protect against infection. As a result, people are considered “partially vaccinated” two weeks after their first dose of mRNA vaccine and “fully vaccinated” two weeks after their second dose. These new vaccine effectiveness findings are consistent with those from Phase 3 clinical trials conducted with the vaccines before they received Emergency Use Authorizations from the Food and Drug Administration. Those clinical trials evaluated vaccine efficacy against COVID-19 disease, while this study evaluated vaccine effectiveness against infection, including infections that did not result in symptoms.

“This study shows that our national vaccination efforts are working. The authorized mRNA COVID-19 vaccines provided early, substantial real-world protection against infection for our nation’s health care personnel, first responders, and other frontline essential workers,” said CDC Director Rochelle P. Walensky, MD, MPH. “These findings should offer hope to the millions of Americans receiving COVID-19 vaccines each day and to those who will have the opportunity to roll up their sleeves and get vaccinated in the weeks ahead. The authorized vaccines are the key tool that will help bring an end to this devastating pandemic.”
 
Pfizer Seeks Covid Vaccine Authorization For 12-15 Year Olds In US
https://www.ibtimes.com/pfizer-seeks-covid-vaccine-authorization-12-15-year-olds-us-3178220

Pfizer-BioNTech asked for authorization Friday to use their Covid-19 vaccine on 12 to 15-year-olds in the United States, which could mark a crucial next step toward achieving herd immunity.

The mass vaccination of teenagers would also relieve an enormous strain on parents who are juggling the demands of homeschooling their children while keeping up with jobs.

The companies said in a statement that they plan to make similar requests of other regulatory authorities worldwide in coming days.

Their request to the US Food and Drug Administration comes after Phase 3 clinical trials of the Pfizer vaccine in 12 to 15-year-olds showed it was 100 percent effective in warding off the disease, according to the companies.

In late March they published the results of trials carried out with 2,260 adolescents in the US whom the companies said showed "robust antibody responses."

The vaccine was "well tolerated with side effects generally consistent with those observed in participants 16 to 25 years of age," the companies said Friday.

For now the vaccine has emergency authorization for use in people aged 16 and over.

Children are less likely to develop severe Covid so vaccinating them has been less of a priority than getting older people inoculated.

But they do make up a large part of the community that will need to be inoculated in order to achieve herd immunity, when the proportion of people with antibodies largely prevents the spread of the virus.

Experts do not know precisely what percentage of the population needs to be vaccinated to get to that point, but one of the leading US immunologists, Anthony Fauci, has put it anywhere between 70 and 85 percent.

In February, he said that US children aged 12 or under could very likely be vaccinated by the start of 2022.

The BioNTech/Pfizer shot is based on new mRNA technology and was the first Covid-19 vaccine to be approved in the West late last year.

In March, the US biotech company Moderna said it had started trials on children aged between six months and 11 years. Johnson & Johnson, whose vaccine was the third approved for US use, has also started trials on the 12 to 17 age group.
 
Yes... if you screw up 15 Million doses due to quality issues than an additional 86 Million doses of J&J vaccine in the Maryland production facility... then it is no surprise the U.S. is going to have a shortage of this vaccine.

J&J vaccine output to drop 85%, White House says issues tied to Baltimore facility
White House says J&J working to fix issues at Baltimore plant.
https://abcnews.go.com/Politics/jj-...ves-white-house-issues-tied/story?id=76979737

We are entering into a period where there is more vaccine than vaccinators.
 
There is another virus on the way
 

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I am pretty sure the Chinese have not run out of viruses.

The last one worked out GREAT for them and their American counterparts.

Could have been a completely different story had we kept the pandemic response team on the ground in Wuhan, China. An Incompetent president really worked out great for China.
 
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