May 5 coronavirus news

Researchers in Norway and Denmark reported Wednesday they had more evidence that AstraZeneca’s coronavirus vaccine might raise the risk of unusual blood clots.

Their study, published in The BMJ medical journal, adds to what’s known about the overall risk, which appears to be small. 

The research team studied the medical records of 280,000 people aged 18-65 who received a first dose of the Oxford-AstraZeneca Covid-19 vaccine in Denmark and Norway in February and March. Both countries have extensive national medical registries, making it easy for researchers to use medical records in their studies.

They pulled out reports of heart attacks, strokes, deep vein blood clots and bleeding events that people suffered within 28 days of receiving a first vaccine dose and compared these with expected rates in the general populations of Denmark and Norway.

They found 59 vaccinated people had blood clots in the veins. In that population over that time, 30 would have been expected. This corresponds to 11 excess events per 100,000 vaccinations. “The absolute risks of venous thromboembolic events were, however, small, and the findings should be interpreted in the light of the proven beneficial effects of the vaccine," they wrote. They called the results “reassuring.”

The team did not look for the specific syndrome that has been linked with AstraZeneca’s vaccine as well as the similar vaccine made by Johnson & Johnson’s Janssen vaccine arm. This condition, known as thrombosis with thrombocytopenia syndrome (TTS) or vaccine induced immune thrombotic thrombocytopenia (VITT), is defined by both an unusual type of blood clot and a low count of platelets, which are clot-forming cells in the blood.

They could not find any particular way to identify who might be most at risk of blood clots. They also found people who had been vaccinated were less likely to die from any cause, compared to years past, although they could not explain that and suggested it might be because healthier people were more likely to have been vaccinated.

“The absolute risks described in this study are small in the context of the proven benefits of vaccination against Covid-19, and the globally high incidence of serious cases of SARS-CoV-2 infection,” they concluded.

In a commentary, Dr. Paul Hunter of the University of East Anglia said people should not hesitate to get AstraZeneca’s or Janssen’s vaccine.

“To decline a vaccine today because it is the Oxford-AstraZeneca or Johnson & Johnson vaccine in the hope of being able to get another vaccine sometime later carries a real risk of dying from Covid-19 before being able to get a preferred vaccine. Those countries that delayed their own vaccination programs at a time of high transmission rates by declining to use available Oxford-AstraZeneca vaccines should know that their decision will have contributed to an increase in the number of avoidable deaths from Covid-19,” he wrote.

 

A third wave of the Covid-19 pandemic is "inevitable" in India, the principal scientific adviser to the Indian government warned on Wednesday.  

"A phase three is inevitable, given the higher levels of circulating virus but it is not clear on what time scale this phase three will occur," K. VijayRaghavan said at a news conference, asking authorities to be prepared for new waves.  

He said a second wave of infections — which continues to paralyze the world's second-most populous country — was predicted but "such a much larger second wave with the ferocity we are seeing" was not predicted.   

Vaccines are effective against the Covid-19 variant first identified in India, the principal scientific adviser said.  

He urged people to follow Covid-19 safety guidelines such as mask use, because they will protect people against infection. "The variants are transmitted the same way as the original strain. It doesn't have other properties of new kinds of transmission in the air or anything like that. It just infects humans in a manner, which makes it more transmissible," he said. 

The Western Indian state of Maharashtra, home to the country's financial capital Mumbai, on Wednesday posted 920 new deaths related to Covid-19 — the highest coronavirus death toll reported in a day in the state since the start of the pandemic, its Press Information Bureau said.

Additionally, a total of 57,640 new coronavirus cases were registered in Maharashtra in the last 24 hours.  

The state government has started preparing for a possible third wave of the pandemic, its Chief Minister Uddhav Thackeray said during an address to the state streamed live on his Facebook page on Wednesday.  

His announcement came hours after the principal scientific adviser to the Indian government, K. VijayRaghavan, warned that a third wave of the Covid-19 pandemic is "inevitable" in India.

Maharashtra was the first Indian state hit hard by the second wave of the pandemic that is currently ravaging the country.  

The state last week extended its Covid-19 restrictions through May 15.

A new report indicates Pfizer/BioNTech’s coronavirus vaccine can protect people against some of the worrying variants of the virus.

A team in the Gulf state of Qatar tested the effectiveness of the vaccine during a time when Qatar was seeing circulation of the B.1.351 variant first seen in South Africa and the B.1.1.7 variant first seen in the UK. The B.1.351 variant, especially, has mutations that allows it to evade the human immune response at least somewhat – including the immune response elicited by vaccines.

One study comparing vaccinated people to non-vaccinated people found strong protection, even against the variants. “The estimated effectiveness of the vaccine against any documented infection with the B.1.1.7 variant was 89.5% at 14 or more days after the second dose. The effectiveness against any documented infection with the B.1.351 variant was 75%,” the researchers wrote in a letter to the New England Journal of Medicine.

The vaccine was more than 97% effective in preventing severe disease or death, they said. It’s the latest in a series of reports indicating vaccines both in use and in development can protect people against the variants. Nonetheless, vaccine makers are already designing and testing vaccines that are targeted specifically against some of the variants.

The team also examined the effectiveness using a different technique called a cohort study, in which vaccinated people were compared to the population as a whole. “Effectiveness was estimated to be 87% against the B.1.1.7 variant and 72% against the B.1.351 variant,” they wrote.

Qatar has reported breakthrough infections in 1,616 people who were fully vaccinated, including two deaths, out of 265,000 fully vaccinated people.

“Nevertheless, the reduced protection against infection with the B.1.351 variant did not seem to translate into poor protection against the most severe forms of infection, which was robust, at greater than 90%,” the team wrote.

Cruise ship operators may begin simulated voyages with volunteer passengers, per an order from the US Centers for Disease Control and Prevention. 

The guidelines are a new phase in the CDC's Framework for Conditional Sailing Order, released in October as a phased approach for preventing Covid-19 transmission aboard cruise ships and eventually resuming passenger cruises.

The instructions include eligibility and requirements for conducting a trial voyage, which would help prepare for future restricted passenger voyages and guide cruise ship inspection on those voyages. 

Simulated voyages must have at least 10% of the maximum number of passengers permitted on board a ship. They must all be at least 18 years old and confirm in writing that they're participating in a simulation voyage.

The CDC guidelines state that the volunteer passengers must be able to furnish proof of vaccination or provide a letter from a physician that they are not in a high-risk category for Covid-19. All volunteers must also be willing to get a Covid-19 test three to five days after the voyage is over.

The CDC's new guidance includes operational procedures for cruise ship operators to prevent the spread of Covid-19, including onboard surveillance, laboratory testing, face mask use, social distancing, passenger interactions and procedures for embarking and disembarking. 

Some background: Since mid-April, the CDC and leaders from other federal agencies have been meeting with cruise line representatives to dialogue and exchange information about the impact of vaccines and various other scientific developments since the original conditional sailing order was released.

A booster shot of Moderna’s coronavirus vaccine revs up the immune response against two worrying coronavirus variants, the company reported Wednesday. Additionally, a booster dose formulated specifically to match the B.1.351 variant first seen in South Africa was even more effective, Moderna said in a statement.

Vaccine makers are trying to get out ahead of the new variants and the design of the new mRNA vaccines made by Moderna and Pfizer make this easier. The genetic material used as the basis of the vaccines is made in a lab and the sequence is easily tweaked.

Moderna tested booster doses of either its current vaccine or a version designed specifically against B.1.351 in 40 people who had already been vaccinated six to eight months before. Blood tests showed half of these volunteers had a low antibody response against B.1.351 and the P.1 variant first seen in Brazil before they got the booster shot.

Two weeks after the booster, their antibody levels had grown against the so-called wild type coronavirus – the variant most common around the world – as well as B.1.351 and P.1, Moderna said in the statement.

“The majority of adverse events were mild or moderate in severity,” the company said.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Moderna CEO Stéphane Bancel said in the statement.

The company is also testing a vaccine booster that combines the original formulation with the B.1.351 specific formula.

“We will continue to make as many updates to our COVID-19 vaccine as necessary to control the pandemic,” Bancel said.

India is experiencing the world's worst Covid-19 outbreak and vaccines are in short supply.

India's vaccine rollout on Saturday widened to everyone age 18 and above, yet a number of states are warning they have no shots to give.

When eligibility was expanded, just over 2% of India's 1.3 billion people have been fully immunized with one of two vaccines — significantly lower than the United States, where 29.8% of the population are fully immunized.

Experts say vaccines are the only way for India to get out of the surge, adding it is a global health issue.

"The only solution for India is to vaccinate itself out of this pandemic," said Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics and Policy in New Delhi. "And the world really needs to help, because if India doesn't fix this problem, the world is not done with Covid."

Here are some of the reasons why there is a shortage of vaccines:

• Exporting vaccines: India rapidly exported a large number of vaccine doses to other countries and through COVAX, the global initiative to provide vaccines to low-income countries. To date, India has exported at least 66 million vaccines.
• Raw materials: The Serum Institute of India, which is producing AstraZeneca’s Covishield, has struggled to keep up the materials needed to produce the vaccine. Much of those come from the United States, but the US placed a ban on those exports to prioritize its own domestic rollout. The ban on materials has been lifted and the Biden administration said it will send vaccines to India – but it will take a while until they actually arrive.
• Coordination with state and local governments: Due to poor coordination between the state and federal governments, certain states are complaining that they are not receiving the vaccines which the federal government had promised to supply. The government has pushed back, claiming any shortages were due to the states' own mismanagement or inaccurate reporting.

CNN international's Cyril Vanier is in the streets of London reporting on the latest Covid-19 headlines from Europe, including travel restrictions and the vaccine rollout.

Watch Go There:

The Biden administration said Wednesday it would support easing patent rules on Covid-19 vaccines, which could increase their global supply, after intense internal debate and strong pushback from American drug-makers.

"The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines," US Trade Representative Katherine Tai wrote in a statement.

Biden and Tai had been weighing the issue after calls from global aid groups and liberal Democrats to support the waivers, which have been proposed by India and South Africa.

Biden as a candidate promised to support such waivers, but had been under pressure from pharmaceutical companies to keep them in place. 

“The Administration’s aim is to get as many safe and effective vaccines to as many people as fast as possible," Tai said in her statement. "As our vaccine supply for the American people is secured, the Administration will continue to ramp up its efforts – working with the private sector and all possible partners – to expand vaccine manufacturing and distribution. It will also work to increase the raw materials needed to produce those vaccines.”