Updated: October 9, 2020 12:53:10 pm
People wearing protective masks wait in line to board a bus in Mumbai on October 6, 2020 (Reuters Photo: Francis Mascarenhas)
When will an antidote to Covid-19 finally be available? The answer to this question will eventually be found this month as a handful of coronavirus vaccine candidates near the end of late-stage clinical trials. At least two vaccine pioneers, Pfizer and Moderna Inc, are set to publish late-stage and Phase 2 results this month.
While experts have said the vaccines are likely to reach the general public between March and April 2021, drug makers have been more ambitious with their calculations, and some companies like Moderna Inc are considering the use authorization route. emergency to launch their vaccines before the end of the year. In fact, Pfizer can also apply for approval from the US FDA. of his vaccine this month, Bloomberg reported.
There are 182 vaccine candidates in clinical or preclinical trials around the world. Of these, 36 are in clinical trials and nine are in final stages of human trials. In India, where two vaccines are in phase II trials and Oxford’s in phase III, the Union Ministry of Health has said it expects supplies to be available from January next year.
This is when drug makers are considering launching their Covid-19 vaccines
Moderna Inc coronavirus vaccine
The American company of Modern biotechnology, whose mRNA-1273 vaccine undergoing phase 3 clinical trials in the United States with 30,000 participants, it has said it could apply for emergency use authorization (EUA) after November 25 once it has enough safety data. During public health emergencies, drug regulators allow authorization of emergency use of unapproved medical products or treatments.
“November 25 is the time when we will have enough safety data to be placed in an emergency use authorization file that we would send to the FDA,” Moderna CEO Stephane Bancel told Forbes. However, he said approval would not be expected until late in the first quarter or early in the second quarter of 2021.
Recent trial results: Recently, results from phase 1 trials of the mRNA-1273 vaccine showed that it was well tolerated and elicited a strong immune response in older adults (participants over 55 years of age).
The study, published in the New England Journal of Medicine, found that the immune response to the vaccine seen in older volunteers was comparable to that seen in younger age groups. In addition, the blood of vaccinated volunteers contained robust binding and neutralizing antibodies against SARS-CoV-2.
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A man dressed in a full protective suit sprays disinfectant on two couples in wedding dresses and suits during the partial lifting of restrictions in La Paz, Bolivia, on Wednesday, October 7, 2020 (AP Photo: Juan Karita).
Pfizer Coronavirus Vaccine
Pfizer Inc, which has jointly developed a candidate with German partner BioNTech SE, plans to distribute its single nucleoside modified messenger RNA (mod RNA) vaccine to Americans before the end of the year if it is deemed safe and effective, said CEO Albert. Bourla. In an interview.
Pfizer has said it will submit data from the last stage of the trial of its BNT162b2 vaccine to the FDA in late October, putting it ahead of the race than Moderna. “If the FDA approves the vaccine, the company is prepared to distribute hundreds of thousands of doses this year,” he said in an interview on CBS television.
Recent trial results: Two vaccine candidates, BNT162b1 or BNT162b2, have undergone human trials so far. According to a report based on early phase clinical trials, published in the journal Nature, both Pfizer vaccines induced a “robust” immune response in healthy adults ages 18 to 55. However, the BNT162b2 vaccine produced a minor adverse reaction, making it the safer candidate of the two.
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Oxford-AstraZeneca Coronavirus Vaccine
According to a report by The Times, pharmaceutical giant AstraZeneca could obtain the necessary clearances for the vaccine candidate from Oxford University before Christmas in the UK. A full program of vaccine implementation for the masses could take six months or less after approval, according to the report. Scientists hope that late-stage trial results will at least show that the ChAdOx1 vaccine (also dubbed AZD1222 and Covishield in India) prevents 50 percent of infections, the threshold for success.
A Filipino girl wears protective masks while looking at an aquarium at the Tandang Sora jeepney terminal in Quezon City, the Philippines, Monday, Oct. 5, 2020 (AP Photo: Aaron Favila).
Recent trial results: On September 9, vaccine trials They were arrested after one of the participants in the UK developed an ‘unexplained illness’ in an adverse event. The participant had reportedly developed a severe spinal inflammatory syndrome called transverse myelitis. However, the trials resumed in the UK on 12 September.
A report on data from an early-stage human trial of the vaccine candidate showed that it had triggered a dual immune response in humans. Made from a weakened version of a common cold adenovirus that causes infections in chimpanzees, the vaccine induced neutralizing antibodies that rendered the virus non-infectious in “all participants” who had received a second dose, according to an article. published in The Lancet.
Johnson and Johnson Coronavirus Vaccine
Johnson and Johnson, which last month began a 60,000-person phase III trial of its JNJ-78436735 single-shot vaccine, expects to release results by the end of the year or early 2021. If positive, the company said it would look emergency use authorization. J&J plans to manufacture up to 1 billion doses in 2021. The antidote stands out from the rest as it is the first that could be a single-shot vaccine. The Moderna Inc, Pfizer Inc, and AstraZeneca vaccines require two injections several weeks apart.
Recent trial results: Phase 1 / 2a human trials showed that a single dose of the vaccine induced strong neutralizing antibody response in almost all participants 18 years of age and older and was generally well tolerated. The 65-year-old participants also showed strong humoral and cellular immune responses.
People walk on the street, as the coronavirus outbreak continues, in Mexico City, Mexico, on October 8, 2020. (Reuters Photo: Carlos Jasso)
Russian coronavirus vaccine (EpiVacCorona)
Almost two months after Russia became the first country to approve a Covid-19 (Sputnik V) vaccine amid skepticism from the global scientific community, the country is likely to approve another chance starting October 15. Called EpiVacCorona, the vaccine is being developed by the Vector State Center for Biotechnology and Virology. Russia plans to make about 10,000 starting doses, and production is expected to start in November.
Recent trial results: The Siberian Vector Institute completed phase II human trials of the vaccine in September and none of the volunteers showed any side effects except experiencing sensitivity at the injection site, Sputnik News said. “The first two phases of the clinical trials demonstrated the efficacy and safety of the EpiVacCorona vaccine,” Vector’s press department told the Interfax news agency.
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