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Cuba decided to make its own COVID-19 vaccines. Now it needs syringes
https://www.miamiherald.com/news/nation-world/world/americas/cuba/article252183433.html

Cuba, which says it has developed fiveCOVID-19 vaccinecandidates and immunized about 2 million people in the island of 11 million, apparently didn’t plan for a crucial part of its vaccination campaign: syringes.

As COVID-19 cases have spiked in recent weeks, the lack of syringes looms as a major challenge for the island, where acrushing recessionhas triggered a food crisis and shortages of medicine and basic necessities. Trump-era sanctions made it harder for Cuba to buy syringes from major manufacturers, which are already swamped with orders from bigger, richer countries.

Making matters worse, some of Cuba’s vaccines require three doses, meaning the Caribbean nation needs more syringes per capita than most countries using the double shots made by Pfizer, Astrazeneca, Moderna and the single-dose jab by Janssen. Cuba is aiming to vaccinate all of Havana’s 2 million population by September and a total of about 10 million people by the end of the year.

When it became clear the island wouldn’t manage on its own, aid organizations in the U.S. and Europe sprang into action. Theylaunched campaignsto collect donations to buy syringes and have them shipped to the island to help narrow a deficit of as many as 25 million syringes.

The response in just little over a month has been “phenomenal,” according to Global Health Partners, a New York-based NGO that’s leading the Saving Lives campaign. Others in Spain, Italy and Latin American nations like Argentina and Honduras have also contributed. Cubans living abroad launched campaigns in cities all over the world, and in Miami a caravan against the U.S. embargo last month also collected local donations.

“I’ve been doing medical aid campaigns to help Cuba for over 20 years and I’ve never seen anything like this,” said executive director Bob Schwartz. He said the organization was initially targeting enough money to buy 3 million syringes, but got such overwhelming support — and $400,000 in donations — that it purchased 4 million and is working to buy another 2 million. He hopes to have them on the ground in Cuba by mid-July. Global Health Partners has a U.S. Commerce Department license to send medical supplies to Cuba.

It’s unclear how many syringes Cuba has or needs, but official state media have publicized donations the island has received from countries like France and Argentina.

The island managed to navigate the first waves of the coronavirus pandemic last year thanks to a strict quarantine and a public health system that, although hit by severe shortages in recent years, remains stronger than its counterparts in many of its Caribbean neighbors. But a new wave after Cuba reopened its borders to tourism in November has placed the island near the top of COVID-19 rankings in the region, triggering calls for the government to start mass vaccinations. Health officials began administering the Soberana and Abdala shots last month even before they were approved by Cuba’s drug authority.

COVID-19 cases, which totaled just over 12,200 in all of last year, surpassed 149,000 so far this year. Since the start of the pandemic Cuba has registered about 162,000 cases and 1,118 deaths, according to the World Health Organization. The island hit a record 1,537 new cases on Tuesday before the numbers fell slightly to 1,403 on Wednesday.

Cuban government officials were criticized for not purchasing vaccines to start protecting its population sooner, while it worked on developing its own shots. The socialist regime opted to focus on a homegrown solution that is presumably cheaper and can ensure a provision of lifesaving shots even amid challenges created by the long-standing U.S. embargo. Cuba’s long tradition of vaccine production, a robust biotech industry and critical mass of scientists set it up for success in becoming the first country in Latin America to produce a COVID vaccine.

The island has five vaccines in various stages of clinical trials and aims to produce around 100 million doses this year to export to countries in Latin America and Africa. It has even flagged the possibility of offering vaccines to tourists. And production can continue over the next few years to supply a likely need of booster shots.

But for now, it needs syringes for its own people. Vaccinations in Havana have slowed transmission there, with infection rates falling to around 370 from a peak of about 800 per day a month ago, according to government data. The improvement is partly due to vaccination efforts, said the Heath Ministry’s director of epidemiology, Francisco Durán García, in a daily televised update on Wednesday.

“We need to continue to advance as fast as we can so that we can see what effect [the vaccine] will have, together with prevention measures that the population already knows,” he said.

One group in Miami wants the Cuban American community to contribute to help families on the island get vaccinated. The Caravan for the Cuban Family and the Lifting of the Blockade of Cuba, which has attracted dozens of supporters in cars and bikes to different Miami locations on the last Sunday of every month since July last year, is spreading the word about how people can donate to the syringe efforts, said Carlos Lazo, one of the organizers.

“A lot of people in Miami have family in Cuba, and I’m sure they want their families protected from COVID-19; joining the campaign for syringes is a huge way to help them,” Lasso said. A caravan is scheduled for Sunday, June 20, departing at 9 a.m. from Ponce de Leon Park in Coral Gables.
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Yeh, there is a lot of backstory dynamics going on there.

Cuba and China were originally co-developing a vaccine in China (china has been working on many, not just the sinopharm, sinovax, whatever) so the story that Cuba was going it alone because big bad United States and other first world countries would not help them is not exactly correct. The truthier story is that they started down the road with China and China was looking to Cuba and South America as big market and using vaccine as a power tool.

Somewhere along the line, China focused on its leading vaccines - sinovax and sinopharm- the one being developed with Cuba or developing one with Cuba fell to the back of the pack. At the same time, Cuba saw that China's vaccines were getting China big bucks and influence but were only marginally effective. So Cuba pulled everything back to Cuba in regard to developing a vaccine and wants to be a mini-China- ie. getting the regional influence that goes with developing a vaccine and wants a big piece of the revenue pie that China also has/had planned for. And of course, as part of the dynamics China controls WHO and they made sure that Cuba got no help in developing a vaccine or in getting covax vaccines because they are now competitors of China. Cuba wants VZ's market, and Central America and South America. etc, etc.

Not sure whether their vaccine is also bogus but I do have respect for any country- regardless of other issues with them- that steps up to the plate and tries to bring some resources to the table rather than this "we go out on the global market to meet our vaccine needs because this is how modern countries do it." I am looking at you Canada and Japan. Very poor showing for advanced countries. Very poor. Fake Canadians arguing that they did not need or want to attempt a vaccine because they know how to go out in the global marketplace is one of the biggest crocks of shiite to come down the pike in a LONG time.
 
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Outbreak hit a Florida government IT office: 2 dead, four hospitalized and the only person not infected was the person vaccinated.

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Americans living abroad plead for COVID-19 vaccine
https://thehill.com/policy/healthcare/559713-americans-living-abroad-plead-for-covid-19-vaccine

Americans living abroad are pleading with the U.S. government to provide them with COVID-19 vaccine doses, particularly as demand is waning domestically with a majority of adults getting their shots.

Expats living in places like Germany, India and Thailand are finding they have to choose between waiting until a vaccine is available in their country of residency or risk a trip to the U.S. or elsewhere to get vaccinated, potentially contracting the coronavirus en route.

Through letters to officials and lawmakers, advocacy groups have called attention to the dilemma faced by some of the estimated 9 million private U.S. citizens overseas, pointing out that they remain subject to federal tax laws just like Americans living in the U.S. who have already received the vaccine.

Retired U.S. Marine Corps Cpl. Samuel Wright, an 81-year-old Vietnam veteran, is one of many veterans living in Thailand. He has not yet been able to get access to the vaccine, saying he feels “abandoned” and “betrayed.”

“It’s like the rug’s been pulled out from under us,” Wright said. “They’ve left us here to die.”

As part of the age group most vulnerable to severe illness, Wright said he and his wife are not willing to play “Russian roulette” and risk traveling to the U.S. to get their shots.

Michael DeSombre, a former U.S. ambassador to Thailand, traveled with his wife and three children to their house in the U.S. to get vaccinated. But he acknowledged that not all American expatriates have the money to travel to the U.S., stay for several weeks to get both shots and pay to quarantine in a hotel if their country requires it upon their return.

“I do think that it is an obligation of America to protect Americans,” said DeSombre, who was ambassador during the Trump administration. “And in a global pandemic, helping ensure that Americans can be vaccinated should be a top priority.”

In Thailand, Democrats Abroad and Republicans Overseas teamed up with other organizations in early May to call on the State Department to launch a pilot program to figure out how to get vaccine doses to Americans overseas.

Thailand has vowed to vaccinate its citizens before giving shots to foreigners, no matter their risk factors or age.

A survey conducted by Democrats Abroad Thailand found that 98 percent of 1,220 Americans in the country said they wanted a U.S.-provided and approved vaccine.

Other countries have launched efforts to vaccinate their citizens in Thailand, including China, which donated 500,000 doses last month in exchange for an agreement for Thailand to give doses to Chinese nationals.

“It's kind of embarrassing when the American can’t do what the Chinese did,” said Tony Rodriguez, Republicans Overseas’ vice president for Asia.

France unveiled its plan to vaccinate its citizens in Thailand on Monday through partnerships with eight hospitals. Starting Wednesday, French nationals age 55 or older will be eligible to register for a free vaccine.

The Biden administration on Monday announced plans to allocate 55 million vaccine doses through the World Health Organization’s COVAX program, without any requirements for recipient countries to vaccinate American citizens living there. The U.S. donation includes about 16 million doses for at least 18 Asian countries, including India and Thailand.

The U.S. previously donated 25 million doses overseas and committed to send 500 million Pfizer-BioNTech doses between August and the first half of 2022.

In India, all adult citizens qualify for the vaccine, but supply is not meeting demand. Children in India are not eligible for shots yet, sparking concerns of another devastating COVID-19 wave.

Suma Shamanna, country chair of Democrats Abroad India who has been abroad for 10 years, said she’s worried to take her 17-year-old son to the U.S., where he is eligible for the Pfizer-BioNTech vaccine, out of concern he would contract the coronavirus during the more than 24 hour journey.

“It’s like choosing between an awful devil and the deep sea,” she said. “I don't know what to do. So many people are in a similar situation.”

Candice Kerestan, the international chair of Democrats Abroad, said she has decided to stay put in Germany and wait her turn, which she expects will come around October. She said she’s worried that leaving the country to seek a vaccine elsewhere could risk her reentry in the event that Germany or the European Union change the rules on foreign citizens.

“This is the reality that we're facing in a lot of corners of the world,” she said.

A State Department spokesperson told The Hill that the agency “has no greater responsibility than the safety and security of citizens overseas,” adding that Americans living abroad should check their U.S. embassy’s website for vaccine availability and eligibility requirements.

“The Department of State does not provide direct medical care to private U.S. citizens abroad,” the spokesperson said. “We are committed to providing all possible consular assistance to U.S. citizens in need overseas, including by providing information on local medical resources when appropriate.”

Marylouise Serrato, executive director of American Citizens Abroad, said the federal government should try to distribute vaccines to as many of its citizens as possible to help halt the pandemic.

“Given the situation, this just isn't about health care,” she said. “It's about fairness and accessibility, and we believe that it's an opportunity for the U.S. government to do the right thing for all its citizens, including those that are living overseas.”

J. Stephen Morrison, director of global health policy at the Center for Strategic and International Studies, said the U.S. faces a “somewhat difficult, agonizing set of trade-offs” with no “quick and satisfying solutions for this.”

He said he does not see the U.S. taking on responsibility to vaccinate millions of Americans living abroad as an option, saying it would be a “huge commitment” and that even the State Department struggled to get its personnel vaccinated worldwide.

“Our embassies are not built to vaccinate hundreds of thousands of U.S. citizens,” Morrison said. “They're not built for that purpose.”
 
Cuba says two of its vaccines are effective against COVID-19. But where is the data?
https://www.miamiherald.com/news/nation-world/world/americas/cuba/article252264428.html

Cuba said its Soberana 02 and Abdala coronavirus vaccines, two out of its five candidates, have shown high efficacy rates against COVID-19 as the island’s bet on a homegrown solution begins to bear fruit.

BioCubaFarma, the government-owned pharmaceutical company, said late Monday that its three-dose Abdala vaccine candidate had an efficacy rate of 92.28% in phase III of clinical trials, while the state-run Finlay Institute of Vaccines said its Soberana 02 had completed phase III trials with an efficacy rate of 62% after two out of three recommended shots. The vaccines are already being administered even before receiving certification from local authorities, after a spike in cases led the government to launch an emergency intervention last month.

Cuban leader Miguel Díaz-Canel celebrated the achievement on social media, lauding Cuba’s scientific community for its sacrifice in the face of challenges posed by the U.S. embargo.

“The success of Soberana 02 and Abdala is yours. Thirteen months ago I asked our scientists to give us a sovereign answer to COVID-19. They didn’t give us just one, they gave us five answers. Two are already vaccines and we are going for more,” he wrote on Twitter, adding the hashtag #CubaSalvaVidas — Cuba saves lives. “That victory is only comparable to the size of our sacrifices.”

Cuba has five candidates at various stages of trials as it opted to produce its own vaccines rather than be forced to compete with richer countries for shots. From the beginning, Díaz-Canel said guaranteeing the nation’s sovereignty was the main goal of producing a homegrown vaccine, so much so that the first candidate was named Soberana, Spanish for sovereign. Abdala was named after a poem by independence hero José Martí, and a third candidate is called Mambisa, the word for 19th Century insurrectionists in the fight against Spanish rule.

While the island has an established biotech industry and produced the world’s first meningitis B shot, for instance, some say the politicization of its COVID-19 vaccine program and a lack of transparency and data about the trials are cause for concern. Cuba hasn’t provided any information about its vaccines to the World Health Organization, even though Díaz-Canel said the island would sell its shots to Latin American countries. Argentina, Mexico, Venezuela, Bolivia and Vietnam, among other countries, have expressed interest in buying Cuban vaccines, and Iran began production of Soberana as part of clinical trials. The island pledged to produce 100 million shots this year but hasn’t defined a vaccination production schedule.

“There are a lot of unanswered questions about Cuba’s vaccine program, and the fact that neither the labs nor the government has shared much information about these vaccines makes me wonder if these efficacy numbers are real,” said Andy Gomez, a Cuba scholar and former senior fellow at the University of Miami’s Institute for Cuban and Cuban-American Studies. “If the vaccines are that good, why not share the data with the world?”

The World Health Organization set up a COVID-19 vaccine tracking system to compile detailed information about each candidate in development by closely monitoring its progress as part of an effort by the global scientific community to share data and to facilitate approvals at a global level. Cuba is listed with three Soberana shots — 01, 02 and Plus — and Abdala, but the WHO table says: “Awaiting information on strategy and timelines for submission.”

Details about the vaccine candidates being tested are scarce on Cuba’s Health Ministry’s trial registry system, but the information provided so far shows they are all protein-based, in which a type of protein located on the virus “spike” is used to induce neutralizing antibodies, basically teaching the immune system to fight off the virus. The technology has been previously used in other vaccines. They are easier and cheaper to produce, and that must have been a key consideration for the socialist island as it faces a severe economic crisis that’s influencing its ability to buy materials. Both the Soberana and the Abdala vaccines require three doses, but Cuban authorities said the Soberana does protect against serious disease and death after just two doses.

Soberana’s 62% efficacy rate is above the 50% threshold required for approval by regulators and health agencies worldwide, including the WHO. Abdala’s 92% rate would make it almost as effective as Pfizer–BioNTech’s 95% during late-phase clinical trials. But Abdala requires three doses, and it’s unclear how fast Cuba will be able to produce its shots as it races to immunize at least 70% of its population by the end of the summer.

The refusal to purchase other vaccines to inoculate its population while it developed its own put Cuba in a vulnerable position after it reopened its borders for tourism in late November. Until then, the island had done remarkably well in controlling transmission through strict lockdown measures and an efficient prevention strategy led by its public health system. In a country of 11 million, fewer than 12,500 cases were registered last year.

But as tourists began flying to the island earlier this year, bringing much-needed cash and helping reignite Cuba’s moribund tourism sector, new and more contagious COVID-19 variants also arrived. Now Cuba is facing the worst COVID-19 wave since the start of the pandemic, with 1,561 new COVID-19 infections reported on Monday, the highest daily number ever. Nearly 170,000 cases have been confirmed so far, while 1,170 people have died, according to Public Health Ministry data.

Cuba and the Dominican Republic are driving most new cases in the Caribbean, and the rate of infections in Cuba is only slowing slightly in Havana, where authorities say two million people have received at least one shot of a vaccine. The Pan American Health Organization warned that the pandemic won’t subside if these countries don’t scale up vaccination, but Cuba hasn’t accepted vaccine donations that are expected to reach Latin American and Caribbean countries from the Group of Seven. Leaders from these rich nations have pledged one billion COVID vaccine doses for countries in need around the world.

“Cuba has experience in biotech, so let’s hope they can produce these shots, and let’s hope they work,’’ Gomez said.
 
Data suggests 'likely' link between COVID-19 mRNA vaccines, rare heart issues in teens, CDC panel says
Of the 484 preliminary reports of myocarditis and pericarditis among vaccinated people under 30, 323 met the CDC’s case definition
https://www.foxnews.com/health/data...-19-mrna-vaccines-rare-heart-issues-cdc-panel

A CDC advisory panel suggested a likely link between mRNA COVID-19 vaccines and rare reports of heart inflammation in younger age groups, but noted that the benefits of receiving a shot still "clearly outweigh" the risks.

The COVID-19 Vaccine Safety Technical (VaST) Work Group, which presented during the Advisory Committee on Immunization Practices (ACIP) meeting Wednesday, said the "data available to date suggest likely association of myocarditis with mRNA vaccination in adolescents and young adults." The group noted myocarditis most often appeared after the second dose, which was similar to data reported through VAERS.

"It does appear that mRNA vaccines may be a new trigger for myocarditis yet it does have some different characteristics..." said Dr. Matthew Oster, MPH, CDC COVID-19 Vaccine Task Force during the panel meeting Wednesday.

Dr. Tom Shimabukuro, deputy director of the Immunization Safety Office at the CDC, noted 484 preliminary reports of myocarditis and pericarditis among vaccinated people under 30 as of June 11 against a backdrop of over 27 million administered doses. Of the total, 323 met CDC’s case definitions for myocarditis and/or pericarditis, 309 of whom were hospitalized, 295 were discharged at the time of analysis and at least 79% recovered from symptoms. Nine remained in hospital care, with two in intensive care, and 14 weren’t hospitalized.

"We’re observing this in younger age groups, mainly in people in the teens and early twenties and observing it more in males compared to females," Shimabukuro said.

Chest pain was the most common presenting symptom, followed by dyspnea, or difficulty breathing.

The panel is still investigating more than 140 preliminary reports to confirm myocarditis or pericarditis through medical records. About 300 million doses have been administered in the U.S. to eligible populations. The ACIP had met to review instances of myocarditis and pericarditis among COVID-19 vaccine recipients and discuss risk-benefit analysis.

A slide published ahead of the presentation during the Work Group Interpretation portion stated that "currently, the benefits still clearly outweigh the risks for COVID-19 vaccination in adolescents and young adults." The group also noted that there is a need for continued monitoring.
 
We will see how this works out...

Venezuela receives first shipment of Cuban coronavirus vaccine
https://www.reuters.com/world/ameri...hipment-cuban-coronavirus-vaccine-2021-06-24/

Venezuela received its first shipment of doses of leftist ally Cuba's Abdala coronavirus vaccine on Thursday, the South American country's vice president said, while slamming wealthy countries for "sabotaging" the COVAX vaccine-sharing scheme.

Authorities did not specify how many doses had arrived from Cuba, but did say that Venezuela had signed a contract to purchase 12 million doses of the shot. Cuba said earlier this week that the three-shot Abdala vaccine had proved 92.28% effective in last-stage clinical trials.read more

"This is true international cooperation, the brotherhood and friendship that we must demonstrate and be an example for other governments," Vice President Delcy Rodriguez said in a state television address.

Venezuela since February has received some 3.5 million doses of Russian and Chinese vaccines for its population of some 28 million. Doctors and vaccine recipients have criticized the socialist government's vaccination rollout as slow and confusing. read more

The once-prosperous OPEC nation is mired in a multi-year economic collapse that has left its healthcare system short of resources and with unreliable electricity and water supply. President Nicolas Maduro's government and allies like Cuba blame U.S. sanctions for the economic woes, though critics say the unraveling of Venezuela's socialist model is the root cause.

President Nicolas Maduro's government in April said it had paid the COVAX initiative, intended to facilitate vaccine access to poor countries, for 5 million doses, which have not yet arrived. Officials said earlier this month that four of its payments had been "blocked."

"Rich countries have sabotaged this solidarity mechanism to distribute vaccines to the world," Rodriguez said. "Rich countries try to use the vaccines as an instrument of political blackmail."

Her comments came after Reuters reported on Wednesday that COVAX, co-led by the World Health Organization (WHO) was planning a reorganization to prioritize poor countries, citing internal WHO documents. read more
 
Canadian study finds mRNA vaccines produce more COVID-19 antibodies than AstraZeneca
https://globalnews.ca/news/7972729/covid-antibody-study-canada-vaccine/

Initial results from a new Canadian study are reinforcing the importance of getting that second COVID-19 vaccine shot — particularly if the first dose was AstraZeneca.

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The study, which was supported by the federal government, found a single dose of either the Pfizer-BioNTech or Moderna vaccine produced short-term antibody levels more than one-and-a-half times greater than those produced by one dose of AstraZeneca.

“We are certainly trying to encourage individuals, particularly if they’ve gotten the AstraZeneca vaccine, to get that second dose,” said Dr. Philip Awadalla, the national scientific director of the Canadian Partnership for Tomorrow’s Health (CanPath), which conducted the study.

The early results come from over 5,600 dried blood spot samples collected from CanPath’s volunteer pool of more than 330,000 Canadian adults between early February and mid-May. Participants also filled out an online questionnaire answering when they were vaccinated and with what type of shot.

So far, the results have shown that about 10 per cent of those vaccinated with one dose of either Pfizer or Moderna — both mRNA shots — did not develop antibody levels against COVID-19 that were any higher from the unvaccinated population.

Yet that number jumps to 30 per cent of those who have received their first shot from AstraZeneca, which is a viral vector vaccine.

Recipients of all three vaccines didn’t see antibodies develop until two to three weeks after getting their shot, the study found, which is consistent with clinical trials from the vaccine manufacturers.

“The difference (is that) over time, what we see in the AstraZeneca vaccines is they’re not producing as much antibodies as those individuals who were vaccinated with the Pfizer or Moderna vaccine,” Awadalla said.

Based on these results, the researchers behind the study are encouraging Canadians who have received AstraZeneca as their first dose to get either Pfizer or Moderna as their second.

Last week, Canada’s National Advisory Committee on Immunization (NACI) made the same recommendation, saying that current evidence pointed at a “better immune response” from mixing a viral vector and mRNA vaccine.

That news was announced just minutes after Frances Maas, a 55-year-old child care worker who lives in Burlington, Ont., booked her second AstraZeneca dose at a local pharmacy.

While she ultimately went through with the appointment due to fear of potential side effects from mixing vaccines, she says the constantly changing advice about AstraZeneca has her feeling like “a troubled kid that nobody knows what to do with.”

“For me, it was about getting vaccinated as soon as I could,” she said when explaining why she chose AstraZeneca for both doses.

“I’m happy to have the information out there, because it allows people to make their own choice. But I feel like for some people, it’s been hard to make that choice because the guidance around (AstraZeneca) changes almost weekly.”
 
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