Ocugen, Bharat Biotech Agree to Commercialize COVAXIN™ in US

 

• Definitive Agreement provides details of the previously announced intent to co-develop COVAXIN™ for the US market
  

• Ocugen and Bharat Biotech to share US commercialization profits

• Ocugen to receive initial supply of COVAXIN™ doses from Bharat Biotech upon authorization from US regulatory authorities while it ramps up manufacturing in the US

• COVAXIN™ received EUA (Emergency Use Authorization) in India in January and is currently in a fully enrolled Phase 3 clinical trial involving 25,800 patients

• COVAXIN™ (whole-virion inactivated COVID-19 vaccine candidate) effectively neutralizes UK variant of SARS-Cov-2 reducing the possibility of mutant virus escape

https://finance.yahoo.com/news/ocugen-bharat-biotech-announce-execution-142700880.html

China cracks fake COVID-19 vaccine ring, confiscates 3,000 doses

 Chinese police arrested more than 80 people and confiscated over 3,000 fake doses of COVID-19 vaccine as part of a campaign to combat vaccine-related crimes, state news agency Xinhua reported.

The suspects had been carrying out the ruse since at least September last year, Xinhua said on Monday, adding that all fake doses had been tracked down.

The fake vaccines were made by injecting saline into syringes, it said. The suspects may have intended to send the vaccines abroad, the government-backed Global Times newspaper reported, citing a source close to a major Chinese vaccine producer.

The police operation was carried out by police in multiple places including Beijing, Shanghai and the eastern province of Shandong, Xinhua said.

Countries around the world from have been rolling out vaccine programmes in the hope of bringing the year-long coronavirus pandemic to an end.

https://www.reuters.com/article/us-health-coronavirus-china-vaccine/china-cracks-fake-covid-19-vaccine-ring-confiscates-3000-doses-xinhua-idUSKBN2A2031

Over half in New Delhi may have had COVID, government survey suggests

 More than half of New Delhi’s 20 million inhabitants may have been infected with the coronavirus, according to a government serological survey whose findings echoed earlier private-sector research.

India has reported 10.8 million COVID-19 infections, the most anywhere outside the United States. But Tuesday’s survey, based on some 28,000 samples, suggests the true figure among its 1.35 billion population is dramatically higher and approaching herd immunity levels.

“In the fifth sero survey done in the national capital of Delhi, (coronavirus) antibodies have been detected in 56.13% of the city’s population,” Delhi Health Minister Satyendar Jain said on Twitter after the report was published.

Separate tests done on more than 700,000 people across India by diagnostics company Thyrocare Technologies showed 55% of the population may have already been infected, its chief told Reuters last week.

The World Health Organization says at least 60% to 70% of a population needs to have immunity to break the chain of transmission, though Indian officials have said a lower level can also slow the virus’s spread.

Jain said New Delhi had largely beaten COVID, and India’s daily cases and deaths fell to eight-month lows on Tuesday.

Overall it has reported 154,486 COVID deaths, giving the country a relatively low fatality rate.

One factor in that is the country’s low average age, medical experts say. Two rich states with relatively older populations - Kerala with 3,459 cases and Maharashtra with 1,948 - now account for nearly 70% of new infections.

India has vaccinated nearly 4 million people since mid-January, when it started what the government touts as the world’s biggest immunisation campaign, which aims to inoculate over 300 million people by August.

https://www.reuters.com/article/us-health-coronavirus-india/over-half-in-new-delhi-may-have-had-covid-govt-survey-suggests-idUSKBN2A21GI

Study suggests Pfizer's COVID-19 vaccine less effective against South African variant

 The Pfizer-BioNTech COVID-19 vaccine may be less able to protect against infection with a South African variant of the virus that has a worrying mutation, according to results of a British study released on Tuesday.

The preliminary data, which have yet to be peer-reviewed and involve a small number of patients, also suggest a significant proportion of people aged over 80 may not be sufficiently protected against new variants of the virus until they have had two doses of the vaccine, researchers leading the study said.

“Of particular concern ... is the emergence of the E484K mutation (found in the South African variant), which so far has only been seen in a relatively small number of individuals,” said Ravi Gupta, a professor at Cambridge University’s Institute of Therapeutic Immunology & Infectious Disease, who co-led the study.

“Our work suggests the vaccine is likely to be less effective when dealing with this mutation.”

Britain and many other countries have begun rolling out the Pfizer-BioNTech vaccine to try to stem the spread of the pandemic disease.

While the highly effective vaccine is designed to be given in two doses around three weeks apart, Britain’s government has opted to extend that time gap to up to 12 weeks to try to swiftly reach as many people as possible with a first dose.

The study released on Tuesday used blood samples from 26 people who had received their first dose of the Pfizer vaccine three weeks previously to test whether the shot would protect against two variants of the SARS-CoV-2 virus - the UK variant, known as B1.1.7., and the South African variant, which has the E484K mutation.

When testing the blood serum samples, all but seven of the participants had levels of antibodies sufficiently high to neutralise the virus – that is, to protect against infection, the researchers said.

When the scientists added all the key mutations found in B1.1.7 variant, however, they found the efficacy of the vaccine was affected, with, on average, two-fold higher concentrations of antibody required to neutralise the virus.

When the E484K mutation was added, even greater levels of antibody were required for the virus to be neutralised - with an average of a 10-fold increase needed, the researchers said.

Dami Collier, who co-led the work, said the findings suggest “a significant proportion of people aged over 80 may not have developed protective neutralising antibodies against infection three weeks after their first dose of the vaccine.”

Clinical trial data released last week on two other COVID-19 vaccines - from Novavax and Johnson & Johnson - also found the South African coronavirus reduced their ability to protect against the disease.

https://www.reuters.com/article/us-health-coronavirus-vaccines-variant/study-suggests-pfizers-covid-19-vaccine-less-effective-against-south-african-variant-idUSKBN2A21OU

DHS promises undocumented migrants equal access to COVID-19 vaccines

 The U.S. government on Monday promised undocumented migrants the same access to COVID-19 vaccines as other civilians, and said inoculation centres would be immigration enforcement-free zones.

The announcement marked the latest in a series of moves by President Joe Biden to reverse the hardline strategy on immigration adopted by his predecessor Donald Trump.

"It is a moral and public health imperative to ensure that all individuals residing in the United States have access to the vaccine... once eligible under local distribution guidelines," the Department of Homeland Security said in a statement. bit.ly/2MMRkPu

In line with sensitive locations policy, enforcement operations will not be conducted at or near vaccine distribution sites or clinics, the DHS also said.

Biden also plans to restore U.S. asylum protections, strengthen refugee processing and set up a task force to reunify families separated by Trump’s border control policies.

https://www.reuters.com/article/us-usa-biden-immigration-vaccine/u-s-promises-undocumented-migrants-equal-access-to-covid-19-vaccines-idUSKBN2A20T0

Biden 'will not accept a scaled-down COVID-19 bill' - White House

 While the White House termed Biden’s discussion with 10 Republicans who pitched a downsized relief effort as “productive,” the Democratic president told the senators their plan did not go far enough.

Biden told the group “that he will not slow down work on this urgent crisis response, and will not settle for a package that fails to meet the moment,” White House spokeswoman Jen Psaki said.

The Republicans who attended the meeting are pushing a COVID-19 relief proposal about one third the size of Biden’s.

Earlier on Monday, top Democrats in the U.S. Senate and House of Representatives filed a joint $1.9 trillion budget measure, a step toward bypassing Republicans altogether on a new virus relief bill.

Senate Majority Leader Chuck Schumer announced the plan for the fiscal-year 2021 budget measure in the Senate and House, saying it would allow Congress to fast-track a coronavirus package for passage by both chambers.

The measure would allow Democrats to bypass a 60-vote threshold in the closely divided Senate and enact coronavirus legislation with a simple majority through a procedure called reconciliation.

It would mark the first time congressional Democrats used the maneuver to flex their legislative muscle since winning razor-thin control of the Senate in two runoff elections last month in Georgia.

The 100-seat Senate is divided 50-50, with Vice President Kamala Harris holding the tie-breaking vote to give Democrats the majority.

Treasury Secretary Janet Yellen is expected to meet with Senate Democrats on the relief measure on Tuesday, the department said.

Schumer spoke ahead of the Oval Office meeting on Monday evening among Biden, Harris and the 10 Republican senators, who have proposed a $618 billion relief package.

Susan Collins, one of the Republicans attending, said the discussion was “frank and useful” but yielded no breakthroughs. She said the sides would keep talking.

What “we did agree to do was to follow up and talk further at the staff level and amongst ourselves and with the president and vice president on how we can continue to work together on this very important issue,” Collins said.

Biden affirmed to the group, however, that he was prepared to push through a comprehensive bill with a party-line vote, Psaki said.

The president “reiterated that while he is hopeful that the Rescue Plan can pass with bipartisan support, a reconciliation package is a path to achieve that end,” Psaki said.

COVID-19 has claimed more than 440,000 lives in the United States, the most of any country, and cost millions of Americans their jobs.

The Republican plan offers no assistance to state and local governments, one of the items that a Biden adviser described as “must-haves” for Democrats in Congress.

According to details released by the lawmakers, the Republican proposal also falls short on another must-have by offering only $1,000 in direct payments to Americans, compared with the $1,400 sought by Biden.

“We have not seen many red lines drawn publicly by Democrats in Congress. I think we will see those red lines if the White House considers taking some things out or delaying some items,” the adviser said, speaking on condition of anonymity.

Passage of new relief legislation would not only affect Americans and businesses but offer an early test of Biden’s promise to work to bridge the partisan divide in Washington.

Ten Republican votes, combined with the backing of 50 Democrats and independents, would be enough to move bipartisan legislation quickly through the Senate. There was little cooperation between the two parties on major legislation in Congress under Republican former President Donald Trump.

Senator Pat Toomey, who does not back the compromise proposal offered by fellow Republicans, said in a statement that the government needed to focus on vaccine distribution at this juncture of the pandemic rather than economic stimulus.

“Once we’ve made significant progress on this goal, then Congress can revisit what pockets of the economy still require assistance,” Toomey said.

https://www.reuters.com/article/us-health-coronavirus-usa-congress/despite-productive-republican-meeting-biden-will-not-accept-a-scaled-down-covid-19-bill-white-house-idUSKBN2A12TV

Russia's Sputnik V vaccine 92% effective in fighting COVID-19

 Russian scientists gave its Sputnik V vaccine the green light on Tuesday saying it was almost 92% effective in fighting COVID-19 based on peer-reviewed late-stage trial results published in The Lancet international medical journal.

They said the Phase III trial results meant the world had another effective weapon to fight the deadly pandemic and justified to some extent Moscow’s decision to roll out the vaccine before final data had been released.

The results, collated by the Gamaleya Institute in Moscow that developed and tested the vaccine, were in line with efficacy data reported at earlier stages of the trial, which has been running in Moscow since September.

“The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency,” said Ian Jones, professor at the University of Reading, and Polly Roy, professor at the London School of Hygiene & Tropical Medicine.

“But the outcome reported here is clear and the scientific principle of vaccination is demonstrated,” the scientists, who were not involved in the study, said in a comment shared by The Lancet. “Another vaccine can now join the fight to reduce the incidence of COVID-19.”

The results were based on data from 19,866 volunteers, of whom a quarter received a placebo, the researchers, led by the Gamaleya Institute’s Denis Logunov, said in The Lancet.

Since the trial began in Moscow, there were 16 recorded cases of symptomatic COVID-19 among people who received the vaccine, and 62 among the placebo group, the scientists said.

This showed that a two-dose regimen of the vaccine - two shots based on two different viral vectors, administered 21 days apart - was 91.6% effective against symptomatic COVID-19.

The Sputnik V vaccine is the fourth worldwide to have Phase III results published in leading peer-reviewed medical journals following the shots developed by Pfizer and BioNTech, Moderna and AstraZeneca.

Pfizer’s shot had the highest efficacy rate at 95%, closely followed by Moderna’s vaccine and Sputnik V while AstraZeneca’s vaccine had an average efficacy of 70%.

Sputnik V has also now been approved for storage in normal fridges, as opposed to freezers, making transportation and distribution easier, Gamaleya scientists said on Tuesday.

Russia approved the vaccine in August, before the large-scale trial had begun, saying it was the first country to do so for a COVID-19 shot. It named it Sputnik V, in homage to the world’s first satellite, launched by the Soviet Union.

Small numbers of frontline health workers began receiving it soon after and a large-scale roll out started in December, though access was limited to those in specific professions, such as teachers, medical workers and journalists.

In January, the vaccine was offered to all Russians.

“Russia was right all along,” Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine abroad, told reporters on Tuesday.

He said the results supported Russia’s decision to begin administering Sputnik V to frontline workers while the trial was still underway, and suggested scepticism of such moves was politically motivated.

“The Lancet did very unbiased work despite some of the political pressures that may have been out there,” he said.

EFFECTIVE IN ELDERLY

The number of people vaccinated in Russia has remained low so far. Authorities have pointed to some early issues with scaling up production while polls have shown low demand among Russians for the vaccine.

Russia has already shared data from its Phase III trial with regulators in several countries and has begun the process of submitting it to the European Medicines Agency (EMA) for approval in the European Union, Dmitriev said.

The data release comes as Europe scrambles to secure enough shots for its 450 million citizens due to production cuts by AstraZeneca and Pfizer. The U.S. roll-out, meanwhile, has been hampered by the need to store shots in ultra-cold freezers and uneven planning across states.

There were 2,144 volunteers over 60 in the Sputnik V trial and the shot was shown to be 91.8% effective when tested on this older group, with no serious side-effects reported that could be associated with the vaccine, The Lancet summary said.

RDIF’s Dimitriev also said the Gamaleya Institute was testing the vaccine against new variants of COVID-19 and the early signs were positive.

The vaccine was also found to be 100% effective against moderate or severe COVID-19, as there were no such cases among the group of 78 participants who were infected and symptomatic at 21 days after the first shot was administered.

Four deaths of participants occurred, but none was considered associated with vaccination, The Lancet said.

“The efficacy looks good, including in the over 60s,” said Danny Altmann, a professor of immunology at Imperial College London. “It’s good to have another addition to the global arsenal.”

ONE DOSE VERSION

The authors of the study noted that because COVID-19 cases were only detected when trial participants reported symptoms, further research was needed to understand Sputnik V’s efficacy on asymptomatic cases and transmission.

Sputnik V has been approved by 15 countries, including Argentina, Hungary and the United Arab Emirates and this will rise to 25 by the end of next week, the RDIF’s Dmitriev said.

The sovereign wealth fund also said vaccinations using Sputnik V will begin in a dozen countries including Bolivia, the United Arab Emirates, Venezuela and Iran.

Hungary was the first member of the European Union to break ranks and unilaterally approve the vaccine last month. It is set to receive a first batch of 40,000 doses on Tuesday.

Germany has said it would use Sputnik V if it is approved by Europe’s drug regulator while France has said it could buy any efficient vaccine.

However, large shipments of the shot have only been sent so far to Argentina, which has received enough doses to vaccinate about 500,000 people. Production for export will primarily be done by RDIF’s manufacturing partners abroad, the fund has said.

On Tuesday, Dmitriev said production had started in India and South Korea, and would launch in China this month. Trial doses have also been produced by a manufacturer in Brazil.

Russia is conducting a small-scale clinical trial of a one-dose version of the vaccine, which developers expect to have an efficacy rate of 73% to 85%.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine/russias-sputnik-v-vaccine-92-effective-in-fighting-covid-19-idUSKBN2A21IT