American pharmaceutical giant, Pfizer Inc. has disclosed that it could seek emergency-use authorization for its Covid-19 vaccine in the U.S. by late November if the shot is shown to be effective in a large late-stage trial.
This announcement rules out the assertion by US President, Donald Trump, that a Covid-19 vaccine would be ready before the Presidential election.
This disclosure was made by the Chief Executive Officer of Pfizer, Albert Bourla, in an open letter published on the company’s website on Friday, October 16, 2020.
While noting that safety reviews will dictate the timeline, with the Food and Drug Administration (FDA) requiring that at least half the people in the study be watched for side effects for two months, Bourla said that milestone should be achieved in the third week of November.
Bourla wrote, “Let me be clear, assuming positive data, Pfizer will apply for emergency authorization use in the U.S. soon after the safety milestone is achieved. An initial readout on whether the vaccine is effective could come later this month, depending on how quickly subjects in the trial, some of whom got a placebo shot, become infected with the virus.’’
Pfizer said the regulatory filing for the vaccine could come as soon as safety data are available, possibly in the third week of November, lifting the company’s shares by 2.5% in premarket US trading.
The timeline by Pfizer now allows for a possible U.S authorization of a Covid-19 vaccine later this year, a major step in controlling the coronavirus pandemic that has killed over a million people globally and devastated the world’s economy.
Although Bourla’s letter puts to rest any notion that a vaccine could be cleared for emergency use in the U.S. before Election day, a goal President Donald Trump had pushed for, the Pfizer CEO’s timetable could give the president a partial victory. If Pfizer is able to, say in late October from the data, show that its inoculation protects people from the virus, that could let Trump claim his administration successfully pushed for a working vaccine before Nov. 3, regardless of whether the FDA has reviewed it.
Pfizer and its German partner BioNTech SE are on track to potentially be the first to show the efficacy of a Covid-19 vaccine. They and rival vaccine developers are intensely working, with an almost unprecedented public interest in every detail of their clinical trials. Johnson & Johnson and AstraZeneca Plc have had studies of possible vaccines or treatments delayed because of safety concerns.
The letter confirmed a timeline laid out by BioNTech CEO Ugur Sahin this week. Sahin said the partners haven’t had to stop their late-stage study over safety concerns.
A group of leading scientists previously urged Pfizer to wait until at least late November before seeking emergency authorization.
COVID-19 Update in Nigeria
On the 26th of October 2020, 119 new confirmed cases and 2 deaths were recorded in Nigeria
The spread of novel Corona Virus Disease (COVID-19) in Nigeria continues to record significant increases as the latest statistics provided by the Nigeria Centre for Disease Control reveal Nigeria now has 62,111 confirmed cases.
On the 26th of October 2020, 119 new confirmed cases and 2 deaths were recorded in Nigeria, having carried out a total daily test of 4,719 samples across the country.
To date, 62,111 cases have been confirmed, 57,571 cases have been discharged and 1,132 deaths have been recorded in 36 states and the Federal Capital Territory. A total of 612,154 tests have been carried out as of October 26th, 2020 compared to 607,435 tests a day earlier.
COVID-19 Case Updates- 26th October 2020,
- Total Number of Cases – 62,111
- Total Number Discharged – 57,571
- Total Deaths – 1,1132
- Total Tests Carried out – 612,154
According to the NCDC, the 119 new cases were reported from 6 states- Lagos (77), FCT (26), Plateau (9), Edo (4), Oyo (2), Nasarawa (1).
Meanwhile, the latest numbers bring Lagos state total confirmed cases to 20,884, followed by Abuja (5,993), Plateau (3,603), Oyo (3,425), Rivers (2,773), Edo (2,652), Kaduna (2,617), Ogun (2,010), Delta (1,812), Kano (1,742), Ondo (1,666), Enugu (1,314), Kwara (1,067), Ebonyi (1,049), Katsina (952), Osun (923), Abia (898), Gombe (883). Borno (745), and Bauchi (710).
Imo State has recorded 614 cases, Benue (486), Nasarawa (479), Bayelsa (403), Ekiti (332), Jigawa (325), Akwa Ibom (295), Anambra (277), Niger (274), Adamawa (257), Sokoto (165), Taraba (140), Kebbi (93), Cross River (87), Yobe (82), Zamfara (79), while Kogi state has recorded 5 cases only.
Lock Down and Curfew
In a move to combat the spread of the pandemic disease, President Muhammadu Buhari directed the cessation of all movements in Lagos and the FCT for an initial period of 14 days, which took effect from 11 pm on Monday, 30th March 2020.
The movement restriction, which was extended by another two-weeks period, has been partially put on hold with some businesses commencing operations from May 4. On April 27th, 2020, Nigeria’s President, Muhammadu Buhari declared an overnight curfew from 8 pm to 6 am across the country, as part of new measures to contain the spread of the COVID-19. This comes along with the phased and gradual easing of lockdown measures in FCT, Lagos, and Ogun States, which took effect from Saturday, 2nd May 2020, at 9 am.
On Monday, 29th June 2020 the federal government extended the second phase of the eased lockdown by 4 weeks and approved interstate movement outside curfew hours with effect from July 1, 2020. Also, on Monday 27th July 2020, the federal government extended the second phase of eased lockdown by an additional one week.
On Thursday, 6th August 2020 the federal government through the secretary to the Government of the Federation (SGF) and Chairman of the Presidential Task Force (PTF) on COVID-19 announced the extension of the second phase of eased lockdown by another four (4) weeks.
Covid-19: AstraZeneca vaccine gets huge boost, produces immune response in elderly
The experimental vaccine being developed by AstraZeneca Plc produced a robust immune response in older adults and the elderly.
One of the world’s leading Covid-19 vaccine candidate, which is being developed by the University of Oxford in collaboration with AstraZeneca, has produced a similar immune response in both older and younger adults with adverse responses being lower among the elderly.
While making the disclosure on Monday, the British drugmaker, AstraZeneca Plc, said the experimental vaccine produced a robust immune response in older adults and the elderly.
This raises hope of the early development of a vaccine for the corona virus that has killed over a million people across the world with a devastating impact on the global economy.
AstraZeneca, described as encouraging, the results and findings on immunogenicity blood tests carried out on a subset of older participants, which echo data released in July that showed the vaccine generated robust immune responses in healthy adults aged 18 to 55
An AstraZeneca spokesman told Reuters, “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.’’
“The results further build the body of evidence for the safety and immunogenicity of AZD1222,” the spokesman said, referring to the technical name of the vaccine.
The news that older people got an immune response from the vaccine is positive because the immune system weakens with age and older people are those most at risk of dying from the virus.
It was earlier reported by Financial Times that the vaccine, being developed by Oxford and AstraZeneca, triggers protective antibodies and T-cells in older age groups – among those most at risk from the virus.
The Oxford/AstraZeneca vaccine is expected to be one of the first from big pharmacies to secure regulatory approval, along with Pfizer PFE.N and BioNTech’s 22UAy.F candidate.
If it works, a vaccine would allow the world to return to some measure of normality after the tumult of the pandemic.
British Health Secretary Matt Hancock said a vaccine was not yet ready though he was preparing logistics for a possible rollout.
Hancock in a chat with BBC, said, “I would expect the bulk of the rollout to be in the first half of next year.’’
He said that is not his central expectation, he does not rule out the possibility of some people having access to the vaccine this year.
Hancock also said, “We want to be ready in case everything goes perfectly but it’s not my central expectation that we’ll be doing that this year, but the programme is progressing well, we’re not there yet.’’
Explore Data on the Nairametrics Research Website
It can be recalled that one of the frontline vaccine candidates being developed by University of Oxford and AstraZeneca Plc, after regulatory approval, resumed its trial in the US after it was initially halted due to some safety concerns
The British drugmaker has signed several supplies and manufacturing deals with companies and governments around the world as it gets closer to reporting early results of a late-stage clinical trial.
COVID-19: WHO warns against Gilead’s remdesivir drug approved by US FDA
WHO has expressed concern over the health implication of Gilead Science Inc’s recently approved remdesivir vaccine.
The World Health Organization (WHO) has warned health officials reviewing Gilead Science Inc’s GILD.O remdesivir against COVID-19 to consider all evidence, including a trial where the medicine failed, before giving its approval to the anti-viral drug.
While making the disclosure during a news conference, Chief Scientist at WHO, Soumya Swaminathan, said that the US regulators, the Food and Drug Administration (FDA), appeared not to have considered the evidence when approving the drug this week.
Nairametrics earlier reported that the US Food and Drug Administration on Thursday, granted full approval to Gilead’s antiviral drug for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.
The approval came days after a WHO study had discovered the remdesivir anti-viral drug had little or no effect on COVID-19 patients’ length of stay in the hospital or chances of survival. WHO said it failed to prevent deaths among patients.
Swaminathan said that the FDA did not appear to have taken the global health body’s study into account in its approval.
When asked about the FDA move during the news conference, Swaminathan said, “We believe our results are very robust. We hope that people who are doing treatment guidelines in other countries, as well as regulators around the world, will take note of our study results, in addition to the other evidence.”
“Because you need to look at the global evidence for a drug before you make decisions,” she added.
For the remdesivir arm of the WHO’s Solidarity trial, 2,743 patients were given the treatment, compared to 2,708 in the control group.
Gilead’s own study of 1,062 participants, produced data indicating that the treatment cut COVID-19 recovery time by 5 days and helped reduce the risk of death in some patients who were getting oxygen.
The WHO said that the company, which has raised the possibility of bias in the unblinded WHO study because patients and their doctors were aware of which treatments were being used, got initial data showing that remdesivir failed the Solidarity trial in late September. However, the U.S. company said that it had told the FDA about initial Solidarity results.
The FDA did not immediately comment on Swaminathan’s statement that the U.S. agency did not take Solidarity data into account in its approval.
The WHO also disclosed on Friday that its formal guidelines on the use of remdesivir for COVID-19 should be ready for release in 3 to 4 weeks after a separate group within the United Nations health agency would have reviewed data from the study.