When is a solution to COVID-19 actually going to become widely available? This month, the answer to this question will finally be found as a handful of candidates for a coronavirus vaccine near the end of late-stage clinical trials.
This month, at least two vaccine frontrunners, US-based Pfizer and Moderna Inc, will release late-stage and Phase 2 results of its trials.
While experts said vaccines were likely to reach the general public in March-April 2021, drug manufacturers were more optimistic with their calculations, with some companies such as Moderna eyeing the emergency-use authorization route to launch their shots by the end of the year. In reality, this month itself, Pfizer may also file for US FDA (Food & Drug Administration) approval of its vaccine, reports suggest.
Out of the 182 vaccine candidates, that are racing to curb the virus that has infected 36.8 million globally, 36 are in clinical trials and 9 are in final states of human trials.
Vaccine from Moderna
US biotechnology company Moderna, whose mRNA-1273 vaccine is undergoing Phase 3 clinical trials on 30,000 participants in the US, said it could pursue emergency use authorization (EUA) after 25 November once it had adequate safety data. During public health emergencies, drug regulators allow unapproved medical drugs or procedures to be allowed for emergency use.
Moderna is confident that by November 25th it will have enough safety data to put into an emergency-use authorization file that will be sent to the FDA. However, they don’t expect the approval to come through until the late first quarter or early second quarter of 2021.
Latest Study Results: Recent results from phase 1 studies of the mRNA-1273 vaccine showed that it was well-tolerated in older adults (participants over 55 years of age) and developed a good immune response.
The results also showed that in older volunteers, the immune response to the vaccine was similar to that seen in younger age groups.
Vaccine from Pfizer
CEO Albert Bourla said in an interview that Pfizer, which has jointly developed a candidate with German partner BioNTech SE, plans to distribute its single nucleoside-modified messenger RNA (modRNA) vaccine to Americans before the end of the year if it is found to be safe and effective.
Pfizer said it would send data from its BNT162b2 vaccine’s late-stage trial to the FDA by the end of October, bringing it ahead of Moderna in the race. “The organization is prepared to deliver hundreds of thousands of doses this year alone if the FDA approves the vaccine,” Mr Bourla said.
Latest findings of the trial: Two candidates for the vaccine, BNT162b1 or BNT162b2, have so far gone into clinical trials. Both the Pfizer vaccines triggered a “robust” immune response in healthy adults aged 18-55 years, according to a study focused on early phase clinical trials published. However, a lower adverse reaction was produced by the BNT162b2 vaccine, making it the safer candidate out of the two.
Vaccine from Oxford-AstraZeneca
The UK-based pharmaceutical giant AstraZeneca could receive the necessary clearances for the Oxford University vaccine candidate by Christmas, according to a report. After approval, a complete vaccine roll-out program for the masses could take six months or less, a report said. Scientists are optimistic that last-stage trial results will at least show that 50 percent of infections, the benchmark for performance, are prevented by the vaccine.
Latest findings of the trial: On September 9, after one of the patients in the UK developed a “unexplained illness” in an adverse case, vaccine trials were stopped. A severe spinal inflammatory syndrome, called transverse myelitis, was allegedly developed by the participant. However, on September 12, trials resumed in the UK.
A study on the vaccine candidate’s early-stage human trial data found that it caused a dual immune response in humans. According to a paper published recently, the vaccine was made from a weakened form of a common cold adenovirus that causes infections in chimpanzees, causing neutralizing antibodies that made the virus non-infectious in “all participants” who were given a second dose.
Vaccine from Johnson & Johnson
Johnson and Johnson, who last month started a 60,000-person Phase 3 trial of their JNJ-78436735 single-shot vaccine, plan to submit results by the end of the year or early 2021. If they are successful, the firm said it will seek permission for emergency use. In 2021, J&J aims to produce as much as 1 billion doses. Since it is the first one that might potentially be a single-shot vaccine, the antidote stands out from the rest. Moderna Inc, Pfizer Inc and AstraZeneca vaccines all need two shots separated by several weeks.
Latest findings of the trial: Phase 1 and 2 human clinical trials showed that a single dose of the vaccine produced a strong neutralizing antibody response in almost all participants 18 years of age and older, and was generally well tolerated. Good humoral and cellular immune responses were also exhibited by participants aged 65 years.
Vaccine from Russia
Almost two months after Russia became the first country in the world to approve a COVID-19 vaccine (Sputnik V) in the midst of skepticism from the global scientific community, the country is likely to approve another shot as soon as 15 October. Called EpiVacCorona, the vaccine is being developed by the Biotechnology Center and Vector State Virology. Russia plans an estimated 10,000 doses to be developed, with production scheduled to begin in November.
Latest study results: Phase II human vaccine trials were completed by the Siberian Vector Institute in September and none of the volunteers showed any side effects except for sensitivity at the injection site, Sputnik news said. “The efficacy and safety of the EpiVacCorona vaccine is demonstrated by the first two phases of clinical trials,” they claimed.