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.
FG explains how the Covid-19 vaccines work and their composition
The NPHCDA Director said that Covid-19 vaccine candidates are of various categories based on their mechanism of action.
The Federal Government through the National Primary Health Care Development Agency (NPHCDA) has explained the composition of the Covid-19 vaccines and how they work.
This is as some of them have been approved for emergency use by the World Health Organization (WHO) and some countries, while others are still at different phases of clinical trials for possible approval.
According to a report from the News Agency of Nigeria (NAN), this insight was given by the Executive Director/Chief Executive of NPHCDA, Dr Faisal Shuaib, who said there were several COVID-19 vaccine candidates.
He said that Covid-19 vaccine candidates are of various categories based on their mechanism of action such as the inactivated or weakened virus vaccines.
He explained that the idea behind the formulation of an inactivated or weakened virus vaccine is to elicit an immune response without causing the disease itself. Shuaib also said there were protein-based vaccines, which used harmless fragments of proteins or protein shells that mimic the Covid-19 virus to safely generate an immune response.
He added that the viral vector vaccines used a virus that had been genetically engineered to produce coronavirus proteins to safely generate an immune response and not give rise to the disease.
Going further, Shuaib pointed out that the Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) vaccines employed a cutting-edge approach that used genetically engineered RNA or DNA to generate a protein that safely prompted an immune response.
What you should know
- It can be recalled that on March 2, 2021, Nigeria received the first set of about 4 million doses of the AstraZeneca Covid-19 vaccine, manufactured by the Serum Institute in India and shipped via the COVAX Facility, a partnership between CEPI, Gavi, UNICEF and WHO.
- A few days ago, the Executive Director of NPHCDA disclosed that a total of 8,491 Nigerians have reacted adversely to the AstraZeneca inoculation since the exercise began on March 15.
- He said that Nigeria recorded 52 cases of moderate to severe incidents of Adverse Effects Following Immunisation (AEFI), presented as fever, vomiting, diarrhoea headaches, dizziness and allergic reactions.
- About 1.09 million Nigerians have so far been administered the first dose of the AstraZeneca Covid-19 vaccine.
COVID-19 Update in Nigeria
On the 19th of April 2021, 70 new confirmed cases 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 164,303 confirmed cases.
On the 19th of April 2021, 70 new confirmed cases were recorded in Nigeria.
To date, 164,303 cases have been confirmed, 154,384 cases have been discharged and 2,061 deaths have been recorded in 36 states and the Federal Capital Territory.
A total of 1.84 million tests have been carried out as of April 17th, 2021 compared to 1.81 million tests a day earlier.
COVID-19 Case Updates- 19th April 2021,
- Total Number of Cases – 164,303
- Total Number Discharged – 154,384
- Total Deaths – 2,061
- Total Tests Carried out – 1,838,174
According to the NCDC, the 70 new cases were reported from 5 states- Lagos (27), Kaduna (16), Ondo (16), Yobe (6), and Bauchi (5).
Meanwhile, the latest numbers bring Lagos state total confirmed cases to 58,119, followed by Abuja (19,756), Plateau (9,035), Kaduna (9,014), Rivers (7,060), Oyo (6,839), Edo (4,897), Ogun (4,639), Kano (3,942), Ondo (3,226), Kwara (3,120), Delta (2,617), Osun (2,572), Nasarawa (2,380), Enugu (2,281), Katsina (2,097), Gombe (2,034), Ebonyi (2,020), Anambra (1,909), Akwa Ibom (1,843), and Abia (1,683).
Imo State has recorded 1,655 cases, Bauchi (1,540), Borno (1,337), Benue (1,188), Adamawa (1,063), Niger (930), Taraba (910), Bayelsa (885), Ekiti (869), Sokoto (775), Jigawa (527), Kebbi (450), Cross River (394), Yobe (365), Zamfara (240), 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.
Governor Babajide Sanwo-Olu of Lagos State announced the closed down of the Eti-Osa Isolation Centre, with effect from Friday, 31st July 2020. He also mentioned that the Agidingbi Isolation Centre would also be closed and the patients relocated to a large capacity centre.
Due to the increased number of covid-19 cases in Nigeria, the Nigerian government ordered the reopening of Isolation and treatment centres in the country on Thursday, 10th December 2020.
On 26th January 2021, the Federal Government announced the extension of the guidelines of phase 3 of the eased lockdown by one month following the rising cases of the coronavirus disease in the country and the expiration of phase 3 of the eased lockdown.
On 28th February 2021, the federal government confirmed that the first tranche of Covid-19 vaccines will arrive in Nigeria on Tuesday, March 2nd, 2021.
On Tuesday, 2nd March 2021, the National Primary health Care Development Agency announced the arrival of the expected COVX Astrazeneca/Oxford covid-19 vaccines.
On Saturday, 6th March 2021, President Muhammadu Buhari and his vice, Yemi Osinbajo received vaccination against the covid-19 as the State House in Abuja.
Nairametrics | Company Earnings
Access our Live Feed portal for the latest company earnings as they drop.
- 2020 FY Results: Guinea Insurance Plc reports a loss of N227.7 million.
- 2020 FY Results: Unity Bank Plc posts profit after tax of N2.09 billion.
- Guinea Insurance Plc reports a loss of N142.13 million in 9M 2020.
- Unilever Nigeria Plc set to hold Annual General Meeting on 6th of May.
- UBA Plc posts profit after tax of N38.16 billion in Q1 2021.