Pfizer’s Covid-19 vaccine paediatric study showed encouraging antibody levels in volunteers and side effects similar to those in teens and young adults
Pfizer and its partner BioNTech said that they would file for authorisation of their Covid-19 vaccine for use in children after clinical trial results showed encouraging antibody levels in volunteers and side effects similar to those in teens and young adults.
The pediatric study, in children ages 5 to 11, is the first to disclose results in young children.
Important points to note:
- The study used a lower dose of the vaccine i.e. 2 x 10mcg doses rather than the 2 x 30 mcg doses used in adults because earlier studies showed that the adult dose could cause more side effects.
- Antibody responses and common side effects were compared between 2,268 children and a separate group of volunteers ages 16 to 25 who received the adult dose. The children were also compared to a placebo group of similar age to determine safety.
- The antibody response in children was roughly comparable to the response in participants ages 16 to 25.
- Pfizer and BioNTech provided only an average antibody level. That could mean that some kids would have lower levels — and less protection.
- Outside experts viewed the data as positive, but limited.
- Pfizer’s press release did not include any data on the extent to which the vaccine reduced the chances that children would become sick. William Gruber, senior vice president of vaccine clinical research and development at Pfizer said that there were not enough cases of illness to tell. But outside experts said it was reasonable to assume that similar levels of antibodies would mean similar protection from disease.
- John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, emphasised that the FDA will be able to analyse both safety and efficacy data from the vaccine. “The bigger dimension is what they’re going to have available for safety assessments because of course that’s going to matter,” Moore said.
- One worry could be cases of myocarditis, an inflammation of the heart, that have been seen, albeit rarely, in adults. These have occurred only once in every tens or hundreds of thousands of vaccine administrations. But no clinical trial is going to be big enough to give an accurate study of such a rare risk.
- “It appears that children in the five to 11 year old age group are the least likely to have severe outcomes of Covid,” said Neuzil, citing recent data from the Centers for Disease Control and Prevention. “So not that it’s not important and not that it’s not a disease worth preventing, but if your severe outcomes are lower, then you’re going to have a higher bar for the vaccine performance. You’re going to want to be very careful about safety issues.” But that has to be balanced against the risk of Covid-19, experts said. Recent data show more infected children are being hospitalised, and more are ending up in intensive care units. It is no longer just children who have other ailments that are becoming sick, they said.
Source: STAT News
Status of administered COVID-19 doses across the globe
As of 20 September, 43.3% of the world population has received at least one dose of COVID-19 vaccine. 5.05 billion doses have been administered globally and 28.87 million are now administered each day.
Only 1.9% of the people in low-income countries have received at least one dose.
Vietnam approves Cuban vaccine, Abdala for COVID-19
Vietnam has approved Cuba’s Abdala vaccine for use against the new coronavirus.
Abdala becomes the eighth COVID-19 vaccine approved for use in Vietnam, which has one of the lowest vaccination rates in the region, with only 6.3% of its 98 million people having received at least two shots.
The ministry last month said Cuba would supply large quantities of Abdala to Vietnam and transfer the production technology by the end of the year.
FDA advisory panel recommends against booster doses of Covid-19 vaccine except for for older and at high risk of severe Covid-19 individuals
An advisory panel to the FDA recommended against a booster dose of a Covid-19 vaccine for most Americans at this time, but voted unanimously to recommend one to those who are 65 or older as well as people who are at risk of severe Covid-19.
It was not immediately clear who would qualify as high risk; fleshing that out will likely fall to the CDC’s advisory committee, the Advisory Committee on Immunisation Practices.
The panelists acknowledged that data show that the protection conferred to the vaccinated is waning over time, but argued the overwhelming number of vaccinated people have sufficient protection at this time to cope with any infection without requiring hospitalisation or risking death.
The FDA is not required to follow the recommendation of its advisory committees but generally does. If the recommendation is adopted by the FDA and Centers for Disease Control and Prevention, it would put the U.S. policy on a par with countries like the United Kingdom.
A separate meeting has been scheduled of ACIP for next week. While the FDA issues decisions on whether to approve vaccines, ACIP advises the CDC on whether it should recommend use of vaccines the FDA has approved.
Source: STAT News
WHO suspends approval process for COVID vaccine Sputnik V due to ‘manufacturing’ concerns
The World Health Organisation (WHO) has suspended the approval process for Russia’s Sputnik V COVID vaccine. According to a regional WHO official, the manufacturing process of the vaccine had not met the necessary standards.
Russia first applied for approval from the WHO for their vaccine in February but has not yet received an Emergency Use Listing (EUL).
The WHO says they have delayed approving the vaccine until a new inspection can be carried out at one of the plants where Sputnik V was manufactured.
Both, the WHO and European Medicines Agency (EMA) said that they are still waiting for complete data from the vaccine’s manufacturers.
Moderna says COVID-19 vaccine protection wanes and makes case for booster doses
New data from Moderna Inc’s large COVID-19 vaccine trial shows that the protection it offers wanes over time, supporting the case for booster doses, the company said in a news release.
“This is only one estimate, but we do believe this means as you look toward the fall and winter, at minimum we expect the estimated impact of waning immunity would be 600,000 additional cases of COVID-19,” Moderna President Stephen Hoge said on a conference call with investors.
Hoge did not project how many of the cases would be severe, but said some would require hospitalisation.
The data stands in stark contrast with data from several recent studies that suggested Moderna’s vaccine protection lasts longer than a similar shot from the Pfizer/BioNTech SE vaccine.
FDA says Pfizer COVID-19 boosters may not be needed, but do improve immunity
U.S. FDA scientists said on Wednesday that booster doses of Pfizer’s (COVID-19 vaccine may not be needed, even though the third shot generates a higher immune response in recipients.
The FDA staff members said in a document prepared for outside advisors that it is still unproven that the efficacy of Comirnaty,the Pfizer/ BioNTech SE COVID-19 Pfizer developed is declining.
COVID-19 vaccines approved and in trials globally
This site (link below) provides some very basic but useful information on the global progress with clinical trials for vaccines for COVID-19. You can also view information on vaccine ‘approvals’ (this can be an emergency use authorisation or a conditional marketing authorisation but not a full approval) by country.
Currently, the situation is as follows:
- No of approved vaccines = 22 (‘approved’ does not necessarily imply full approval. It can mean an emergency use authorisation,a conditional marketing authorisation or full approval)
- No of vaccines in Phase I trials = 37
- No of vaccines in Phase II trials = 62
- No of vaccines in Phase III trials =37
More detailed information on regulatory progress of vaccines or medicines is available on here.
An Israeli doctor working on an experimental treatment for Covid is looking to team up with the world’s largest pharmaceutical firms, such as AstraZeneca, to develop the treatment.
Nadir Arber has been working on a drug called EXO-CD24 that could turn severe cases of Covid-19 into manageable medical events.
The drug, now in a phase-three trial, focuses on stopping the ‘cytokine storm’ that affects the lungs of some patients.
CD24 is a small protein that is anchored to the membrane of the cells and it serves many functions including regulating the mechanism responsible for the cytokine storm. Arber stressed that their treatment, EXO-CD24, does not affect the immune system as a whole, but only targets this specific mechanism, helping find again its correct balance.
Dr Arber said his firm was working with investment banking advisers on raising finance from strategic partners, as his team was looking to raise more than $20million (£15million) for development of the drug, with the aim of approval by the FDA, the American medical regulator.
New TGA restrictions on prescribing ivermectin for COVID-19
The TGA, acting on the advice of the Advisory Committee for Medicines Scheduling, has placed new restrictions on the prescribing of oral ivermectin.
General practitioners are now only able to prescribe ivermectin for TGA-approved conditions (indications) – scabies and certain parasitic infections. Certain specialists including infectious disease physicians, dermatologists, gastroenterologists and hepatologists (liver disease specialists) will be permitted to prescribe ivermectin for other unapproved indications if they believe it is appropriate for a particular patient.
These changes have been introduced because of concerns with the prescribing of oral ivermectin for the claimed prevention or treatment of COVID-19. Ivermectin is not approved for use in COVID-19 in Australia or in other developed countries, and its use by the general public for COVID-19 is currently strongly discouraged by the National COVID Clinical Evidence Taskforce, the World Health Organisation and the US FDA.
Source: TGA website
Pfizer to seek regulatory approval for vaccine in children 5 years and over
Pfizer and BioNTech announced this week that they will soon seek approval from global regulators for use of its coronavirus vaccine in children ages 5 and over.
“We will be presenting the results from our study on five- to 11-year-olds to authorities around the world in the coming weeks,” Ozlem Tureci, the co-founder of BioNTech and its chief medical officer, told German news outlet Der Spiegel.
Scott Gottlieb, the former commissioner of the FDA and a Pfizer board member, said in August that the vaccine maker “could be in a position” to file an application for vaccine approval in children as early as October.
“This fall, Pfizer is going to be in a position … to file data with the FDA at some point in September and then file the application potentially as early as October, so that’ll put us on a time frame where the vaccine could be available at some point late fall, more likely early winter, depending on how long FDA takes to review the application,” Gottlieb said on CBS’s “Face the Nation” at the time.
Source: The Hill
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights 30 Aug – 2 Sept 2021
EMA reviewing cases of multisystem inflammatory syndrome with COVID-19 vaccines
EMA’s safety committee (PRAC) is assessing whether there is a risk of multisystem inflammatory syndrome (MIS) with COVID-19 vaccines following a report of MIS with Comirnaty. The case occurred in a 17-year old male in Denmark who has since fully recovered.
Some cases of MIS were also reported in the EEA following vaccination with other COVID-19 vaccines. As of 19 August, cases reported as MIS in children in the EEA from from the EudraVigilance database were: Comirnaty: 5; Spikevax: 1; Vaxzevria: no case; COVID-19 Vaccine Janssen: 1. Some of the cases occurred in adults rather than in children.
MIS is a serious inflammatory condition affecting many parts of the body and symptoms can include tiredness, persistent severe fever, diarrhoea, vomiting, stomach pain, headache, chest pain and difficulty breathing. MIS has previously been reported following COVID-19 disease. The Danish patient, however, had no history of COVID-19.
At this stage, there is no change to the current EU recommendations for the use of COVID-19 vaccines.
The PRAC will now assess the available data on MIS to determine whether the condition can be caused by the vaccine and recommend whether any changes to the product information of the vaccines are needed. EMA and national authorities will provide further updates as necessary.
COVID-19 Vaccine Janssen and venous thromboembolism
As part of the ongoing close safety monitoring of the COVID-19 vaccines, PRAC is reviewing data on cases of venous thromboembolism (blood clots in the veins) with COVID-19 Vaccine Janssen.
This safety issue is distinct from the very rare side effect of thrombosis with thrombocytopenia syndrome (TTS) (i.e. blood clots with low blood platelets).
Venous thromboembolism was included in the risk management plan for COVID-19 Vaccine Janssen as a safety issue to be investigated, based on a higher proportion of cases of venous thromboembolism observed within the vaccinated group versus the placebo group in the first clinical studies used to authorise this vaccine.
PRAC will assess additional data from two large clinical trials of the vaccine, which are to be submitted shortly by the marketing authorisation holder of the vaccine, in order to further evaluate whether the condition is linked to the vaccine.
Source: EMA website
Japan finds another Moderna vial suspected to contain foreign substance
Kanagawa prefecture said that several black particles in one Moderna vaccine vial were found upon checking for foreign substances before its use, and it has put the rest of the lot on hold.
Japan suspended the use of 1.63 million doses of Moderna shots last week after being notified of contamination in some of the supply. Moderna and Spanish pharma company Rovi , which bottles Moderna vaccines, have said the cause could be a manufacturing issue, and European safety regulators have launched an investigation.
Moderna has said no safety or efficacy issues had been identified from the issue. No similar Moderna incident has been reported in other countries.
Kanagawa prefecture said the vaccine’s domestic distributor, Takeda Pharmaceutical Co Ltd , had collected the vial with the suspected contaminant and that about 3,790 people had already received shots from the same lot.