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These COVID-19 vaccine candidates in late stage clinical trials

Amid the race to develop an effective vaccine against COVID-19 in record time, six candidates have now entered the late stage clinical trial, according to the New York Times vaccine tracker

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Covid 19 Vaccine

Amid the race to develop an effective vaccine against COVID-19 in record time, six candidates have now entered the late stage clinical trial, according to the New York Times vaccine tracker.

The latest entrants in this crucial phase of vaccine development are Moderna and one jointly developed by US-based Pfizer and German biotech firm BioNTech.

Pfizer and BioNTech on Monday announced the start of a Phase 2/3 study of its vaccine candidate BNT162b2.

The Phase 2/3 study will involve up to 30,000 participants between 18 and 85 years of age.

The Phase-3 trial by Moderna will also include 30,000 participants who do not have COVID-19.

The mRNA-1273 vaccine is designed to induce neutralising antibodies directed at a portion of the coronavirus “spike” protein, which the virus uses to bind to and enter human cells.

The Phase 3 trial is crucial in the development of a vaccine as it can help answer the question whether it is effective enough to prevent the targeted disease.

Earlier, at least four other COVID-19 vaccine candidates entered the phase-3 trials.

The COVID-19 vaccine candidate developed by scientists at the University of Oxford and UK-based global biopharmaceutical company AstraZeneca made early progress and entered into phase trials in South Africa and Brazil.

The results of the Phase 1/2 trials of the vaccine published in The Lancet medical journal last week showed that it produces strong immune responses.

The Phase 3 trial of this vaccine will also be conducted in several other countries including India. This vaccine will be called Covishield in India.

In an interview with IANS last week, Adar Poonawalla, CEO, Serum Institute of India (SII), said that as per the arrangement with AstraZeneca, SII will be making one billion doses of Covishield vaccine over the next one year for India and other low-and-middle-income countries (GAVI countries).

The Phase 3 clinical trials are expected to commence in India around August 2020 in which 4,000-5,000 patients are likely to participate.

A Phase 3 clinical trial of Chinese state-owned pharmaceutical company Sinopharm’s inactivated Covid-19 vaccine started in Abu Dhabi in the United Arab Emirates, the Abu Dhabi government media office said in July.

The UAE health authorities recently issued a permit for up to 15,000 volunteers to take part in the trials.

Chinese vaccine maker Sinovac in July said it had received approval for starting a phase-3 clinical trial of its COVID-19 vaccine candidate, CoronaVac, in Brazil.

This study will recruit nearly 9,000 healthcare professionals working in COVID-19 specialised facilities in 12 clinical sites located in several states in Brazil.

The New York Times vaccine tracker also includes a Phase-3 trial by Murdoch Children’s Research Institute in Australia to evaluate the efficacy of a Bacillus Calmette-Guerin vaccine, originally developed as a protection against tuberculosis, to protect against COVID-19.

While work on more than 165 COVID-19 vaccine candidates has started, 27 vaccines have entered human trials, according to the tracker.

China’s military has received approval for using a COVID-19 vaccine jointly developed by its research unit and CanSino Biologics Inc.

The approval for the Recombinant Novel Coronavirus Vaccine (Ad5-nCoV) was granted on June 25, for one year.

The phase-1 and phase-2 clinical trials of the Ad5-nCoV were conducted in China.

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Coronavirus: Karnataka’s Covid tally crosses 5 lakh

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Coronavirus in India

Bengaluru, Sep 19 : With 8,626 fresh cases across the state on Friday, Karnataka’s Covid-19 tally crossed the 5 lakh mark, while 10,949 people were discharged after treatment in the last 24 hours.

“The number of positive cases across the state is 5,02,982, including 1,01,129 active cases, while 3,94,026 cases were discharged since March 8,” said the health bulletin.

With 179 patients succumbing to the infection during the day, the state’s toll has gone up to 7,808.

Bengaluru, which is the epicentre of the disease in the state, registered 3,623 cases during the day, taking its tally to 1,87,705, including 41,914 active cases, while 1,43,198 patients were discharged till date, with 2,725 in the last 24 hours.

With 37 deaths during the day, the city’s toll has increased to 2,592.

“The number of patients in the intensive care units (ICU) across the state is 814, including 271 in Bengaluru Urban district, Dharwad 74, Ballari 67 and Hassan 62,” the bulletin said.

Mysuru saw 600 new cases, Udupi 493, Dakshina Kannada 456, Ballari 296, Shivamogga 257 and Belagavi 221.

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Pakistan reports 752 new cases of coronavirus: Health Ministry

So far 3,090,660 tests have been done across the country, including 33,865 in the last 24 hours.

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Islamabad, Sep 18 : Pakistan has reported 752 new cases of coronavirus, taking the total number of infections to 304,386, the health ministry said on Friday.

The Ministry of National Health Services said nine more people succumbed to the virus in the last 24 hours due to which the toll stands at 6,408.

“The coronavirus cases continue to rise with the current figure standing at 304,386. The death toll also has touched 6,408,” the ministry said in a statement.

The ministry said at least 579 were in critical conditions and it showed that 291,683 people have fully recovered so far, which meant that the number of active patients was 6,295.

Sindh reported 133,125 cases, Punjab 98,142, Khyber-Pakhtunkhwa 37,242, Islamabad 16,033, Balochistan 13,991, Gilgit-Baltistan 3,381 and Pakistan-occupied Kashmir 2,472 cases.

So far 3,090,660 tests have been done across the country, including 33,865 in the last 24 hours.

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Moderna shares Covid-19 vaccine trial blueprints, will others follow?

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COVID-19 Vaccine

US biotech firm Moderna, one of nine companies in the late stages of clinical trials for a Covid-19 vaccine, has become the first to publish the complete blueprints of its study following calls for greater transparency.

The initiative puts pressure on other companies to follow suit, especially Pfizer, the other American company currently carrying out Phase 3 trials in the US.

This is the final stage before approval, in which a vaccine and a placebo are tested on thousands of participants to verify the medicine is safe and effective.

The vaccine race has become deeply politicized in the US in the run-up to the presidential election in November, as President Donald Trump touts one against criticism of his handling of the pandemic.

Trump repeated on Wednesday that the first vaccine would be approved by October, increasing concerns that the White House will place pressure on the approval body, the Food and Drug Administration (FDA).

“I don’t trust Donald Trump,” his rival from the Democratic party Joe Biden said Wednesday.

Experts and officials in the Republican president’s administration agree that it’s not possible to predict the results of the trials that are underway, and it’s highly unlikely to have strong data before the end of 2020.

Vaccine doses will be initially very limited, according to health authorities.

Moderna’s CEO Stephane Bancel said on Thursday his company would know whether their vaccine works by November.

October is possible but unlikely, he told CNBC.

The trial protocol published Thursday, which runs to 135 pages and is marked “confidential,” fixes the parameters of the experiment.

The most important of these is how it will judge whether results are conclusive.

The reality of an immunization trial is that it’s necessary to wait until a certain number of volunteers become naturally infected, in order to compare outcomes in the placebo group against the group given the vaccine.

So the decline in the rate of infection in the US could theoretically delay the results — possibly until December, said Bancel.

As of Thursday, Moderna had recruited 25,296 volunteers. Among them, 10,025 had received their second dose, 28 days after the first.

It’ll take a few more weeks to recruit the full quotient of 30,000 participants and for them to receive their second doses.

Only Covid-19 infections recorded two weeks or more after the second dose are counted, to give the vaccine sufficient time to take effect.

Interim analyses by a committee of independent experts are planned over the course of the trial to verify whether a high statistical threshold of effectiveness has been reached, and to monitor for serious side effects.

The FDA has stated its bar for approval is a vaccine that reduces the risk of falling sick with Covid-19 by 50 percent.

“This has the key information (for) stopping rules, interim analyses and efficacy assumptions. Applaud their transparency,” Eric Topol, director of the Scripps Research Institute and one of the critics leading the charge against possible political interference, told AFP.

Moderna also said that 28 percent of its participants were from racial minority groups.

Having sufficient participants among black and Hispanic people in particular is crucial in obtaining statistically representative results for these communities that have been disproportionately hit by the pandemic.

The decision by Moderna, which has received $2.5 billion in US government money, now leaves the spotlight on Pfizer, the other company in the running for the first US authorization.

Its CEO has repeatedly said the company will have its results by the end of October, which is in line with Trump’s wishes.

The other frontrunner is AstraZeneca, which has co-developed a vaccine with the University of Oxford.

The medicine’s global trials were suspended last week after a participant had an unexplained illness, but were later restarted in the UK, Brazil, and South Africa. The US remains the exception for reasons that aren’t yet known.

“Transparency is crucial to overcome vaccine hesitancy. Other vaccine makers should follow @moderna_tx lead,” tweeted Angela Rasmussen, a virologist at Columbia University.

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