New Delhi, Sep 15: Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial. The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be “scrupulously” followed by Serum Institute of India (SII).

SII has also been asked to submit to the DCGI’s office details of medication used in accordance with the protocol for management of adverse events. The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ”an unexplained illness” in a participant in the study.

On Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority’s (MHRA) confirmed that the trials were safe. SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, on Tuesday submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial.

According to Tuesday’s order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunization in their clinical trials subject to certain conditions. DSMB, India, also has recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to certain conditions.

According to the order, SII has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants. The Pune-based firm has also submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequale.

“In view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India and in UK revoke herewith the order dated September 11 issued under Rule 30 of the New Drugs and Clinical Trials Rules, 2019. “You may recommence the clinical trial as recommended by DSMB, India, as per already approved protocol and the provisions laid down under the New Drugs and Clinical Trial Rules, 2019, subject to the conditions mentioned,” the order said.

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TAMPA, Florida: Democrat Joe Biden on Tuesday made his first campaign visit of the year to Florida, where opinion polls show a tight race against President Donald Trump amid signs of lagging support for Biden among the battleground state’s crucial Hispanic voters.

With less than 50 days until the Nov. 3 election, the Biden campaign is trying to overcome concerns about enthusiasm among Florida Latinos and a disinformation campaign that has tried to paint the moderate Democratic nominee as a socialist.

A NBC News/Marist opinion poll showed the two White House contenders in a dead heat in Florida and Trump with a 4-point edge over Biden among the state’s Latinos. Democrat Hillary Clinton won their votes by 27 percentage points in 2016, according to exit polls. Other polls have shown Biden leading among state Hispanics but still trailing Clinton’s support.

Trump won Florida over Clinton by just 1.2 percentage points, which helped propel him to the White House. His inroads with Florida Hispanics have been fueled by his strength with conservative Cuban-Americans, a Republican-leaning bloc he has courted throughout his presidency.

“Clearly, there has been some hemorrhaging of Hispanic support going on, mainly Cuban-Americans,” said Democratic state Senator Annette Taddeo, a Colombian-American. “The Republicans have worked really, really hard, and they have been constantly present.”

The steady drumbeat of Republican attacks on Biden, the vice president under Barack Obama, falsely labeling him a socialist has also taken a toll, Florida Democrats said.

Florida’s Republican lieutenant governor, Jeanette Núñez, a daughter of Cuban immigrants, said Biden’s agenda contradicted the values of “faith, family and freedom” held by Hispanic voters.

“He is completely in the pocket of the radical left – those people who look fondly at the socialist dictatorships in Cuba, Venezuela and elsewhere,” Núñez told reporters on a call arranged by the Trump campaign on Tuesday.

Felice Gorordo, a Cuban-American Biden ally, said the campaign should focus on younger Cuban voters, who do not see foreign policy as the No. 1 issue, making them more open to the campaign’s central message on recovery from the COVID-19 crisis.

Some Florida Democrats said they had noticed a sharp rise in videos and commentary in social media and texts repeating falsehoods about Biden and pushing other conspiracy theories about Democrats.

“We are seeing a massive disinformation campaign in Spanish aimed at our community calling Biden and Democrats socialists, and it is having an effect,” said Evelyn Perez-Verdia, a Colombian-American Democratic strategist in south Florida.

Asked by a Reuters reporter as he boarded a flight to Florida how he would handle disinformation campaigns targeting Latino voters, Biden said he would “Just tell the truth.”

“Everybody knows who Trump is. People are going to show up and vote,” Biden said.

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Florida, where Hispanics make up about 20% of the state electorate, is a linchpin in Trump’s re-election strategy. A Biden win of Florida’s 29 electoral votes would sharply reduce Trump’s chances of another term – no Republican has won the presidency without Florida since Calvin Coolidge in 1924.

Trump, a former New York businessman, changed his permanent residence to Florida last year.

Nationally, Hispanics make up the largest minority voting group, at more than 13% of eligible voters. Biden’s support with Latino voters across the country has dropped; they favored him over Trump by 9 points in August, down from 30 points in July, according to Reuters/Ipsos data.

The Biden campaign, urged by Taddeo and other Democrats to do more to court Latinos, has stepped up Spanish-language and bilingual advertising and hired more staff.

Ahead of events on Tuesday in Tampa and Kissimmee, two Florida cities with heavy Puerto Rican populations, Biden said: “I am going to work like the devil to make sure I turn every Latino and Hispanic vote.”

As part of his trip Biden is expected to sit for an interview with Telemundo, a Spanish-language network.

He will get some help from former Democratic primary rival Michael Bloomberg, who will spend $100 million on Biden’s behalf in Florida, with a particular focus on Latino voters.

Polls show Biden running ahead of Clinton’s level of 2016 support among seniors in Florida, another crucial voting bloc, and among white voters, giving him plenty of pathways to reach a majority, Democrats said.

They said there was plenty of opportunity for Biden to make up ground with Florida Hispanics, particularly among the state’s non-Cuban Latinos who include a fast-growing Puerto Rican population and Mexicans, Colombians and Venezuelans.

Biden has vowed to rescind many of the hardline immigration policies put in place by Trump’s administration, and has emphasized the need for broad health and economic strategies to recover from the novel coronavirus pandemic that has hit Latino communities particularly hard.

Unite the Country, a Democratic group that supports Biden, is spending $1.4 million on digital advertising aimed at Latinos in south Florida. Steve Schale, the group’s chief executive, said the group could be most effective by increasing support of non-Cuban Hispanic voters who are not attached to a party and are typically more persuadable.

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The S&P 500 ended up slightly on Tuesday as investors hoped the Federal Reserve would stick with its supportive policy stance as the central bank’s two-day meeting got under way.

Apple Inc shares rose on Monday and early in Tuesday’s session, giving the indexes a boost. But Apple turned slightly lower in the wake of its product event, which included the rollout of a new virtual fitness service and a bundle of all its subscriptions, Apple One. The stock often dips after running up prior to that event.

The Nasdaq also rose and outperformed the other two major indexes, while the S&P 500 index gained, extending its recovery from a brutal sell-off earlier this month that had halted a Wall Street rally.

In its first policy meeting since Fed Chair Jerome Powell announced a more accommodative stance on inflation, the central bank could switch its Treasury purchases toward more long-dated debt to keep long-term yields low, some strategists said.

“While the economy is slowing, the upcoming macro news should be friendly, which should indicate the Fed will have no change in terms of policy,” said Peter Cardillo, chief market economist at Spartan Capital Securities in New York.

Data on Tuesday showed U.S. factory output increased strongly in August. Separately, U.S. import prices increased more than expected for the same month, supporting the view that inflation pressures were building up.

Unofficially, the Dow Jones Industrial Average rose 1.42 points, or 0.01%, to 27,994.75, the S&P 500 gained 17.58 points, or 0.52%, to 3,401.12 and the Nasdaq Composite added 133.67 points, or 1.21%, to 11,190.32. ROBOT

The S&P 500 financial index fell, with Citigroup Inc dropping following a report that federal regulators were preparing to reprimand the U.S. lender for failing to improve its risk-management systems.

JPMorgan Chase & Co also slipped as it lowered its full-year net interest income forecast.

(Additional reporting by Medha Singh and Devik Jain in Bengaluru; Editing by Shounak Dasgupta and David Gregorio)

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Bhubaneswar, Sep 15: Odisha reported more recoveries of COVID-19 patients than new cases on Tuesday as 3,714 people were cured of the disease while 3,645 got infected with it, a health department official said. The number of recoveries in the state is now 1,25,738, which is 79.25 per cent of the total coronavirus caseload of 1,58,650.

The toll due to the contagion rose to 645 with eight more people succumbing to the infection – three in Cuttack and one each in Boudh, Kandhamal, Rayagada, Sambalpur and Subarnapur during the day, he said. Total 53 COVID-19 patients in the state have died due to comorbidities, according to the official.

“Today, the number of recoveiesy (3,714) is more than the detection of new positive cases (3,645),” the official said. The case fatality rate has declined to 0.40 per cent from 0.47 per cent on September 1, the data released by the department said.

Odisha currently has 32,214 active cases against Monday’s 35,928 cases, it said. Of the 3,645 new cases, 2,151 were reported from various quarantine centres and 1,494 were detected during contact tracing.

Khurda district, of which state capital Bhubaneswar is a part, reported the maximum number of fresh cases at 517, followed by Cuttack at 357 and Puri at 246, the official said. BJD MLA from Pipili in Puri district, Pradeep Maharathy, is among the fresh cases on Tuesday. He asked people who recently came in touch with him to isolate themselves and undergo tests, if necessary.

As many as 25.16 lakh samples have been tested for COVID-19 in the coastal state so far, including 43,940 on Monday. Meanwhile, the health and family welfare department has asked the district authorities to strengthen critical care facilities at the local level in order to reduce load on COVID-19 hospitals in Bhubaneswar and Cuttack.

The direction came in wake of a surge of positive cases in the twin cities. The two cities together house as many as 6,761 active cases of the state’s total 32,214 cases. “Bhubaneswar and Cuttack carry 20.98 per cent load of active cases,” the official said.

He said that the COVID-19 patients in the twin cities face shortage of hospital beds as they are already occupied by the patients from other districts. “About 40 per cent of the COVID-19 hospital beds in the rest of the state remain vacant while there is crowding in Bhubaneswar and Cuttack,” the official said.

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