society
Pfizer, BioNTech Set To Eradicate Covid-19 With Vaccine
The battle for Victory over Covid-19 has received a major boost as Pfizer and partner BioNTech said Monday that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement — and relief — in the face of the global pandemic.
The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective.
The Phase 3 study is ongoing and additional data could affect results.
In keeping with guidance from the Food and Drug Administration, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose. Pfizer expects to cross that threshold in the third week of November.
“I’ve been in vaccine development for 35 years,” William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told STAT. “I’ve seen some really good things. This is extraordinary.” He later added: “This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.”
Although it is a bright spot in the battle against the pandemic and a triumph for Pfizer and BioNTech, a German company, key information about the vaccine is not yet available. There is no information yet on whether the vaccine prevents severe cases, the type that can cause hospitalization and death.
Nor is there any information yet on whether it prevents people from carrying the virus that causes Covid-19, SARS-CoV-2, without symptoms.
Without more information, it’s too early to start predicting how much of an impact the vaccine could make, said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy.
“I don’t want to dampen any enthusiasm for this vaccine. I just want us to be realistic,” Osterholm said. “For a vaccine to really have maximal impact, it’s going to have to also reduce severe illness and death. And we just don’t know yet.”
Because the vaccine has been studied for only a matter of months, it is impossible to say how long it will protect against infection with the virus. The vaccine does cause side effects, including aches and fevers, according to previously published data. Gruber said that he believed the side effect profile was comparable to standard adult vaccines, but probably worse than Pfizer’s pneumonia vaccine, Prevnar, or a flu shot.
The results have not been peer-reviewed by outside scientists or published in a medical journal, and even Pfizer and BioNTech have been given no other details about how the vaccine performed by the independent monitors overseeing the study.
Initial supplies of the vaccine, if authorized, will be limited. Pfizer says up to 50 million doses could be available globally. by the end of the year, with 1.3 billion available in 2021. There are also expected to be distribution challenges. The vaccine must be stored at super-cold temperatures, which could make it extremely difficult to deliver to many places. Pfizer has said it is confident those issues can be managed.
Although the estimate of the efficacy of the vaccine could change as the study is completed, it is close to a best-case scenario. That also bodes well for other vaccines in the late stages of testing, including those developed by Moderna, AstraZeneca, and Johnson & Johnson.
Both Pfizer’s vaccine and Moderna’s use messenger-RNA, or mRNA, technology, which uses genetic material to cause the body to create a protein from the virus; the immune system then recognizes the virus and learns to attack. Other vaccines in the late stages of development use genetically engineered viruses for a similar purpose, or pieces of protein that are directly injected. No mRNA product has ever been approved by regulators.
The story of how the data have been analyzed seems to include no small amount of drama. Pfizer, seeing an opportunity to both help battle a pandemic and demonstrate its research prowess, made decisions that were always likely to make its study the first of a Covid-19 vaccine to produce data — including its decision to have an independent group of researchers, known as a data safety and monitoring board, take an early look at the data in the 44,000-volunteer study before its completion.
The first analysis was to occur after 32 volunteers — both those who received the vaccine and those on placebo — had contracted Covid-19. If fewer than six volunteers in the group who received the vaccine had developed Covid-19, the companies would make an announcement that the vaccine appeared to be effective. The study would continue until at least 164 cases of Covid-19 — individuals with at least one symptom and a positive test result — had been reported.
That study design, as well as those of other drug makers, came under fire from experts who worried that, even if it was statistically valid, these interim analyses would not provide enough data when a vaccine could be given to billions of people.
In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study. It’s not known how many were in the vaccine arm, but it would have to be nine or fewer.
Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday. When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.
This means that the statistical strength of the result is likely far stronger than was initially expected. It also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted.
Gruber said that there will not be another interim analysis conducted in the study. He also said that Pfizer’s estimate that it could file for authorization of the vaccine by the third week of November was based on the assumption that the FDA would be willing to accept two-month safety data on half the volunteers in the study as initially planned, when it was to include 30,000 volunteers, not more than 44,000, as is now the case. Those discussions are ongoing.
But Gruber said he now expects that by the time of the planned meeting of the FDA’s vaccine advisory committee in December, the study’s efficacy portion could be completed, having reached 164 cases of Covid-19.
He also emphasized that although there will only be a few months of data from this study, results from earlier studies make him optimistic that immunity from the vaccine will not wane rapidly.
The study has enrolled 43,538 volunteers, the companies said, and 38,955 have received their second dose. About 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.
Bourla, Pfizer’s CEO, said the results mark “a great day for science and humanity,” in a statement, saying they provide “initial evidence of our vaccine’s ability to prevent Covid-19.” He added: “We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
Alleged Manipulation of Defilement Case Sparks Call for Review of Legal Advice in Lagos
By Ifeoma Ikem
A legal controversy has emerged in Lagos following a petition seeking a review of a legal advice issued in a case involving two female teachers accused of negligence in a child injury incident at a nursery school in Ikorodu.
The petition, submitted by Crown Cannan Attorneys, urges the Lagos State Ministry of Justice to reconsider the legal advice issued on September 16, 2022, in the case titled Commissioner of Police vs. Ambassador Rukayat Tobiloba and Rukayat Lawal.
Addressed to the former Lagos State Attorney-General and Commissioner for Justice, Moyosore Onigbanjo, the application argues that the legal advice may have been influenced by what the petition describes as a “deliberate manipulation of facts.”
According to counsel representing the defendants, the allegations stem from an incident that allegedly occurred on October 26, 2021, at Great Kezino Nursery and Primary School located in the Adamo area of Ikorodu, Lagos.
The defendants, Ambassador Rukayat Tobiloba, 26, and Rukayat Lawal, 24, were reportedly the class teacher and assistant class teacher respectively in charge of a Nursery One class where the incident occurred.
Court documents indicate that a three-year-old pupil, identified as Victim A, was reportedly injured after another pupil allegedly pierced a pencil into her private part during school hours.
The prosecution claims the incident occurred due to the failure of the teachers to exercise adequate care and supervision over the children under their custody.
Based on this allegation, the two educators were charged with negligence under Section 252 of the Criminal Law of Lagos State, 2015, which addresses acts that may cause harm through lack of proper care.
The defendants were subsequently arraigned before Magistrate Court No. 2 in Ikeja on April 19, 2022, where they faced a one-count charge relating to the incident.
During the investigation conducted at the Gender Unit of the Lagos State Police Command in Ikeja, several civil society groups reportedly monitored the proceedings.
Among them were representatives of the African Women Lawyers Association (AWLA) and other non-governmental organizations.
These groups reportedly raised concerns about what they described as a growing tendency to weaponise allegations of child abuse in ways that could unfairly damage reputations and careers.
In its petition, the defence team argued that the case deserves a fresh review to ensure that justice is served based on verified facts rather than assumptions or public pressure.
They urged the Ministry of Justice to carefully reassess the legal advice and the circumstances surrounding the investigation to determine whether the prosecution should proceed as currently framed.
Legal observers say the outcome of the requested review could determine the next stage of the case and may also highlight broader concerns about investigative procedures and child protection cases within the justice system.
Reacting to a viral social media post by Ambassador Rukayat Tobiloba, who claimed she might be jailed for defilement, the head teacher of Great Kezino Nursery and Primary School, Mrs. Edaolaropin Toyin, provided the school’s account of events.
According to her, the pupil identified as Victim A was enrolled in the Nursery One class on September 20, 2021, which had about 15 pupils.
She explained that on October 26, 2021, the pupil was transported home on the school bus after closing hours and handed over to her father around 4:30 p.m.
“Later that night, the pupil’s mother allegedly contacted the head teacher, claiming her daughter cried while bathing and alleged that a male classmate, Victim B, had inserted a pencil into her private part during school hours,” she said.
The school, however, rejected the allegation, maintaining that no such incident occurred while the child was in its custody.
“The following morning, the teacher visited the pupil’s home, where the father reportedly denied the mother’s account of the incident,” Toyin added.
She said the situation escalated later that day when the child’s parents arrived at the school with police officers from Imota Police Station demanding that the alleged male classmate be produced.
The head teacher further stated that the school management had supported Tobiloba throughout the legal process.
“Since the incident happened, the school management has never stopped supporting Tobiloba’s welfare until last year when she sent a WhatsApp message saying she was no longer interested in the court matter, claiming she had relocated to Ibadan,” she said.
She described the claims currently circulating on social media as “defamatory narratives.”
*GEN CG MUSA SUPPORT INITIATIVE MOURNS FALLEN HEROES AND URGES UNITY IN SECURITY SUPPORT
The Gen Christopher Gwabin Musa Support Initiative (GCGMSI) expresses its heartfelt condolences to His Excellency Gen Christopher Gwabin Musa OFR, Minister of Defence of the Federal Republic of Nigeria, Grand Patron of the Initiative, and the families of the fallen heroes who courageously lost their lives in a recent attack by ISWAP in Konduga, Marte, Jakana, and Dalori in Borno State, northeast Nigeria. Among the tragic losses were three senior military commanders: Major U.I. Mairiga, Lt-Col Umar Faruq, and Lt-Col S.I. Iliyasu, who dedicated their lives to the service of our nation.
The GCGMSI implores the public to continue supporting our security agencies, emphasizing that the safety and security of our nation is a collective responsibility. Every day, our security forces pay the ultimate price to safeguard our country. We urge the public to remain supportive, pray for their success, and refrain from politicizing the security challenges we face.
This was contained in a statement signed by the Convener, Ibrahim Dahiru Danfulani Sadaukin Garkuwan Keffi/Betara Biu, which has been made available to the press. The statement highlights the initiative’s profound concern for the losses sustained by our security personnel and reflects on the broader security situation in Nigeria.
In his unwavering commitment to addressing the insecurity plaguing our nation, the Minister of Defence, Gen Christopher Gwabin Musa, has consistently engaged in urgent meetings with service chiefs, reinforcing strategic plans to combat threats and enhance national security. His leadership and decisive actions demonstrate a dedication to restoring peace and stability across our regions, ensuring a safer environment for all Nigerians.
society
SECURITY IS A SHARED RESPONSIBILITY: BACKING OUR MINISTER OF DEFENCE GEN. CHRISTOPHER GWABIN MUSA OFR
SECURITY IS A SHARED RESPONSIBILITY: BACKING OUR MINISTER OF DEFENCE GEN. CHRISTOPHER GWABIN MUSA OFR
By Ibrahim Dahiru Danfulani
In these challenging times, it is essential for all Nigerians to rally behind our leaders, particularly His Excellency Gen. Christopher Gwabin Musa OFR, the Minister of Defence. The security of our nation is not a matter to be taken lightly or politicized. Gen. Musa, recognized for his unwavering dedication and sacrifice, has served our country commendably throughout his life.
Following the recent reshuffle of service chiefs by President Asiwaju Bola Ahamed Tinubu GCFR, which resulted in Gen. Musa’s retirement as Chief of Defence Staff, many voiced their concerns. Yet, upon his appointment as Minister of Defence, there was a renewed sense of hope among the populace. Gen. Musa has embraced his role with an unwavering commitment, often sacrificing his rest to ensure the safety and security of our great nation.
While it is undeniable that Nigeria faces security challenges, we must approach these issues with unity rather than division. It is crucial to recognize that those who politicize our national security are often those who have not contributed positively to the success of our security agencies. Instead of spreading negativity, we should support Gen. Musa in his mission to restore peace and stability.
To achieve our collective goal of a secure Nigeria, we must provide Gen. Musa with the trust he deserves. His vision and determination, paired with our support and prayers, can pave the way to overcoming the challenges we face. It’s time for every Nigerian to put aside political differences and work together for the common good. Let us have faith in our leaders and trust in Gen. Musa’s ability to steer our nation towards safety and security.
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