Vaccine out by January 2021? Taking a closer look at the development of the COVID-19 vaccines from around the globe
COVID-19 pandemic has taken the world by storm for the most part of 2020. However, we can be relieved as several vaccines are currently being reported to be in the final stage of development and will be out in the market soon in the upcoming weeks. The second wave of coronavirus pandemic rising in Europe and America, which led to many countries go into a lockdown state again for the second time this year. COVID-19 vaccine front-runners which have shown positive results in the last stage of clinical trials are Moderna Inc and Pfizer, which are expected to be released in the upcoming weeks.
We can now hope for a vaccine to be out by December. Although facing several setbacks while in the Phase III trials in the past two months, the vaccine developed by the University of Oxford and AstraZeneca PLC has reportedly produced immune responses in both elderly and young people.
Usually, it takes about 10 to 15 years for a vaccine to be developed. However, the fast and unprecedented pace by which the vaccines are being developed by the researchers has led experts in the field, including the UK Vaccine Taskforce, to believe that the first generation of shots “is likely to be imperfect” and that “might not work for everyone”.
UK Vaccine Taskforce Chair Kate Bingham wrote in a piece published in The Lancet medical journal, “However, we do not know that we will ever have a vaccine at all. It is important to guard against complacency and over-optimism.”
She also added, “The first generation of vaccines is likely to be imperfect, and we should be prepared that they might not prevent infection, but rather reduce symptoms, and, even then, might not work for everyone or for long.”
According to data by the World Health Organization (WHO), more than 150 COVID-19 vaccines are in development across the world. Among them, 44 are said to be in the clinical trials, and 11 undergoing late-stage testing.
AstraZeneca has said earlier this week that their AZD1222 or ChAdOx1 nCoV-19 vaccine candidate “has produced a robust immune response in older adults and the elderly, those at highest risk of severe illness.” The news is exciting as older patients have been affected worse by the virus. According to a report by Bloomberg, the majority of deaths have occurred to patients above the age of 60. Younger patients who have the virus, though not having a hundred percent recovery rate have a much more recovery rate than that of older patients.
AstraZeneca said, “It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the Covid-19 disease severity is higher.” In the trials conducted by the company, participants aged 56 and over showed low-levels of adverse reactions.
According to a report from the newspaper The Sun, the staff at a London hospital trust have been told to be ready to receive the first batches of the Oxford shot from November 2. AstraZeneca has made the vaccine from a weakened version of a common cold virus that causes infections in chimpanzees. The vaccine is expected to roll out before the end of the year.
SII CEO Adar Poonawalla has informed NDTV that the vaccine being tested in India by Serum Institute and named Covishield might be ready as early as December. They also informed that the first batch of 100 million doses might be available by the second or third quarter of 2021.
Poonawalla said, “If we don’t go for an emergency license, our trials should be over by December and then we can maybe we can launch in India in January subject to the UK trial, which is on the verge of being completed.”
He also said, “If the UK, in the next two weeks, were to unbind their study and share the data and be confident that it’s safe, then we can, after two-three weeks, apply to the Indian regulator to look at a possible emergency license if that’s what the government wants.”
“That review could take about two-three weeks, I imagine and then you can have a vaccine by December. We are aiming for 100 million available doses at first. This should be available by Q2-Q3 of 2021,” he added.
The progress of the vaccine got halted on the 9th of September as one of the participants developed an “unexpected illness” during the trials. The late-stage trials were restarted in the United States last week. A volunteer participating in the clinical trial of the COVID-19 vaccine has died earlier this months. The news of the unexpected death of the volunteer sparked concern among the scientific community. AstraZeneca later reported that the volunteer did not receive the company’s shot.
Pfizer had previously said that they might have vaccine efficacy data in October and hoped to supply more than 40 million doses in the United States by the end of this year if the clinical testings proceed as expected. The regulators would also need to approve its single nucleoside-modified messenger RNA (modRNA) vaccine developed by the company.
Pfizer Chief Executive Albert Bourla said to AFP, “We have reached the last mile here. If all goes well, we will be ready to distribute an initial number of doses.” He had also said that the firm has not reached key benchmarks yet.
A US-based company Moderna Inc is also expected to submit interim results of its mRNA-1273 vaccine trials next month. Wall Street Journal reports that positive result might see the company receive US approval for emergency-use authorization as early as December. The company is expecting to bring out 20 million doses of its experimental vaccine by the end of the year.
On the other hand, after two months of becoming the first country to approve a Covid-19 vaccine, Russia has submitted applications to WHO for emergency-use listing (EUL) and prequalification of its Sputnik V vaccine. If the vaccine meets WHO standards of quality, safety, and efficacy, the Russian vaccine would be eligible for worldwide access.
In India, Dr. Reddy’s Laboratories (DRL) received regulatory approval from the Drugs Controller General of India to conduct mid-stage and late-stage human trials of the Sputnik V vaccine candidate in India. Mankind Pharma, a Delhi based company is expected to market and distribute the Russian COViD-19 vaccine. Prior to that, the vaccine would be tested on 1,500 participants across at least 10 sites, including those in Maharashtra, Andhra Pradesh, and Telangana.
After a pause due to safety concern, US pharmaceutical major Johnson & Johnson, which has resumed late-stage trials of its single-shot JNJ-78436735 in the United States. The company has recently announced that the first batches of its candidate could be available for emergency use as soon as January. The result of the 60,000 person study conducted by the company is expected to be out before the end of this year. The pause which was made by the company and not the regulators was because a participant involved in the test developed an “unexpected illness”.