The European Medicines Agency is still reviewing the safety of a Covid-19 vaccine submitted by Pfizer and BionNTech and has not received clinical trial data, EU sources said Monday.
A “rolling review” of several potential vaccines is underway and, for now, Brussels is sticking by its forecast that one may be approved and available “early next year”, one source said.
Earlier, the companies said that ongoing trials had found that their vaccine was 90 percent effective in preventing Covid-19 infections, sending hopes soaring for an end to the epidemic.
The European Medicines Agency (EMA) has begun an expedited procedure to examine potential vaccines, and did nothing to pour cold water on reports of a breakthrough.
But a spokeswoman for the Amsterdam-based agency said they had yet to receive the results of clinical trials.
“Through rolling reviews, EMA can exceptionally evaluate data as it becomes available, ahead of a formal marketing-authorisation application,” she said.
“We evaluated the first batch of data on the vaccine, which came from laboratory studies (non-clinical data).
“The agency is currently assessing a second batch of data which relate to the quality of the vaccine, including data related to its ingredients and the way it is produced.
“Any new data available for this vaccine will be reviewed in the same way. We have not received nor assessed the emerging clinical data at this point and can therefore not comment further.”
Separately, in Brussels, a European source confirmed this and added “any prediction would be risky, but we have good indications that the first vaccine may be available early next year.”
European officials, including the president of the European Commission Ursula von der Leyen have previously used this timeline when talking about a future vaccine.
And Brussels has put funding aside to reserve tens of millions of doses of future vaccines from several companies, including that from US giant Pfizer and its German partner BioNTech.
Yuletide: Observe COVID-19 safety protocols, virus still in our midst, Oyo govt. warns residents
Oyo state government , on Tuesday, warned residents to continue to strictly observe the COVID-19 safety protocols, as it declared that the virus is still very much around.
An advisory by the Emergency Operations Centre (EOC) of the state warned that COVID-19 “is still very much around with us,” adding that residents of Oyo State must strictly adhere to safety protocols even during the Yuletide.
The advisory indicated that Oyo residents should, at this period, follow the direction of the state-sponsored advocacy on COVID-19, #Own Your Action, noting that responsible living and strict adherence to the guidelines will help the state to curtail the spread of the disease during the festive period.
A statement by Mr. Taiwo Adisa, Chief Press Secretary to Governor Seyi Makinde, indicated that the advisory by the EOC equally commended residents of the state for the efforts made so far in complying with the COVID-19 prevention measures in the state.
The statement read: “The State Government salutes the resilience and fortitude with which members of the public have carried themselves in spite of all the challenges faced in the year 2020. We believe as the year comes to an end, and another year is on the horizon, the hopes and aspirations of the citizens of the state will be actualised.
“With this, it is expected that as responsible citizens of our dear state, we will continue to comply with the COVID-19 prevention measures in public places especially offices, shopping malls and outlets, schools, recreation centres and any location outside the homes.”
The statement warned that in light of the end of the year activities and forthcoming festivities, visitors and residents of the state would have to be responsible in organising social events, noting that all events must be organised in compliance with the COVID-19 guidelines.
The government promised to continue to work assiduously to deliver on its promises to the citizens, noting, however, that residents should “share the joy and not the virus,” at the period.
“The reality of end of year social activities which involves traveling into and also within the state will soon commence with the festivities. This is to implore visitors and residents of the state to be wise and responsible in attending and organising social events in compliance with the state COVID-19 advisories.
“Thus, religious and community leaders, organisers of end of year programmes including children parties and concerts, as well as owners of recreational facilities, are to remember that the pandemic is ongoing, and to ensure the orderly conduct of their activities to prevent widespread infections in the State.
“The government of Oyo State will continue to work assiduously to deliver on her promises to the citizens.
“Let’s make this a season to ‘spread the joy, not the virus,” the statement read, while wishing all residents happy celebrations.
138 NYSC members test positive for COVID-19, NCDC reveals
No fewer than than 138 members of the National Youth Service Corps (NYSC) had so far tested positive for the Coronavirus (COVID-19) pandemic and have been isolated, the Nigeria Centre for Disease Control (NCDC) disclosed.
NCDC also revealed that 34,685 people have been tested for coronavirus (COVID-19) across all the National Youth Service Corps (NYSC) camps in the country.
The Director-General of the Nigeria Centre for Disease Control (NCDC), Dr Chikwe Ihekweazu, made this known on Monday at the briefing of the Presidential Task Force (PTF) on COVID-19 in Abuja, the nation’s capital.
Dr. Ihekweazu added that those whose samples were collected included corps members and NYSC officials in various camps.
“We tested over the last few weeks a total, so far, of 34,785 people of which we found a total of 138 positive only.
“So, we have a total prevalence of 0.4 per cent; in fact, about one in 200 new people coming into the camps turned out to be positive.
“None of them were allowed into the camp; all of them were excluded and either managed at home or the treatment centre depending on if they had symptoms and what state they were in,” the NCDC boss added.
He also spoke about the progress made so far in the area of vaccination against the disease, noting that four vaccines had already been announced.
Dr Ihekweazu stated that while these have brought excitement, there were lots to consider to guide decisions on which to go for when they became available.
The Minister of Health, Dr Osagie Ehanire, who also briefed reporters, gave an update on COVID-19 infections, treatment, and fatalities.
He was that Nigeria was by no means out of the woods yet and urged the people to present themselves for testing.
Dr Ehanire said the PTF would continue to keep vigilance as COVID-19 cases surge in other parts of the world.
He gave an assurance that the ministry was taking measures to ensure that vaccine security was sure once they were available for the public.
The minister also disclosed that it has been confirmed that the strange deaths in Delta and some other states were as a result of yellow fever.
Experimental COVID-19 Vaccine Shows 95% Effectiveness – Pfizer, BioNTech
Pfizer and BioNTech said Wednesday that a completed study of their experimental Covid-19 vaccine showed it was 95 percent effective.
They said the two-dose vaccine had no serious safety concerns and that the companies will apply for emergency use authorization from US regulators “within days.”
The announcement came as coronavirus cases are surging in the US and other parts of the world, and boosted hopes for an end to the pandemic that has upended life around the globe.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” said Pfizer CEO Albert Bourla.
“With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world,” he added.
Pfizer had said last week after a preliminary analysis that its product was more than 90 percent effective.
On Monday another biotech firm involved in the race to develop a vaccine, Moderna, said its own vaccine was 94.5 percent effective, according to a preliminary analysis.
Pfizer has previously said it expected to contact the US Food and Drug Administration to apply for an Emergency Use Authorization by the third week of November.
The FDA had imposed a requirement on Covid-19 vaccine makers of having at least two months of follow-up with volunteers after their second dose, taken 28 days after the first, in order to ensure the drugs are safe.
Moderna developed its vaccine along with the US National Institutes for Health.
Both vaccines use mRNA (messenger ribonucleic acid) technology to deliver genetic material to the body that makes human cells create a protein from the virus.
This trains the immune system to be ready to attack if it encounters SARS-CoV-2.
Other vaccines that are in late-stage trials, such as one being developed by Johnson & Johnson and another by Oxford University and AstraZeneca, use modified viruses to deliver genetic material for the same purpose.
No mRNA vaccines have ever been approved, but Anthony Fauci, the United States’ top infectious disease scientist, told AFP Tuesday the technology had now “established itself.”
Tweets by @megaiconmagg
Subscribe to our Newsletter
MegaIcon Magazine Facebook Page
Education1 day ago
Senator Buhari expresses joy as National Assembly passes bill establishing Federal University of Agriculture, Oke Ogun
Sports3 days ago
PHOTOS: Ex 3SC Chairman, Busari buried in Ibadan
News1 week ago
Don’t drag us into UI succession battles – Oyo BIR boss
Sports1 week ago
Argentine football ‘lord’, Maradona is dead