London, July 27 (IANS) Total antibody levels produced by both Pfizer and AstraZeneca appear to start declining from as early as six weeks after two vaccine doses and can reduce by more than 50 per cent over 10 weeks, according to a new study stressing the need for booster doses.The study, led by researchers of the University College London, showed that the waning effect of the vaccine doses were consistent across all groups of people regardless of age, chronic illnesses or sex.Published as a research letter in The Lancet, the study included data from over 600 people and showed antibody levels are substantially higher following two doses of the Pfizer vaccine than after two doses of the AstraZeneca jab.They are also much higher in those with prior SARS-CoV-2 infection.The researchers highlighted that although the clinical implications of waning antibody levels are not yet clear, some decline was expected and current research shows that vaccines remain effective against severe disease.For Pfizer, antibody levels reduced from a median of 7506 U/mL at 21-41 days, to 3320 U/mL at 70 or more days. For AstraZeneca, antibody levels reduced from a median of 1201 U/mL at 0-20 days to 190 U/mL (67-644) at 70 or more days."The levels of antibody following both doses of either the AstraZeneca or Pfizer vaccine were initially very high, which is likely to be an important part of why they are so protective against severe Covid-19," said Maddie Shrotri from the UCL Institute of Health Informatics."However, we found these levels dropped substantially over the course of two to three months. If they carry on dropping at this rate, we are concerned that the protective effects of the vaccines may also begin to wear off, particularly against new variants; but we cannot yet predict how soon that might happen," she added.The findings support recommendations from the UK Joint Committee on Vaccination and Immunization (JCVI) that adults who are clinically vulnerable, those aged 70 years or over, and all residents of care homes for older adults should be prioritised for booster doses."In addition, those who were vaccinated with the AstraZeneca vaccine, including most care home residents, are likely to have much lower antibody levels than those vaccinated with the Pfizer vaccine, so this may also need to be considered when deciding who should be prioritised when boosters are rolled out," said Professor Rob Aldridge from the UCL Institute of Health Informatics.However, the study included only a small sample size and different people will have different levels of immunity depending on the virus neutralizing ability of their antibodies as well as their T-cell responses. Thus, additional research is important to establish if there is an antibody level threshold needed for protection against severe disease, the researchers noted.--IANSrvt/ksk/
New York, July 24 (IANS) The US government has purchased an additional 200 million doses of the Pfizer-BioNTech Covid-19 vaccine.This brings the total number of doses to be supplied by Pfizer and BioNTech to the US government under its existing supply agreement to 500 million.About 110 million of the additional doses will be delivered by December 31, 2021, while the remaining 90 million doses will be delivered by April 30, 2022, Pfizer and BioNTech announced in a statement on Friday.The US government also has the option to acquire an updated version of the vaccine to address potential variants as well as new formulations of the vaccine, if available and authorised, it said.The additional vaccines could be used to inoculate children under 12 and provide booster doses to the "immunocompromised" people in the US.Early this week, US President Joe Biden had said that children under the age of 12 could "soon" be eligible to receive a Covid 19 vaccine, predicting that his government could green light the rollout for young Americans in the next few months. The vaccines for children could be ready by August or later in the fall -- a time many schools across the US plan to reopen, the CNN reported.Amid surging infections from the Delta variant, the US Centers for Disease Control and Prevention (CDC) is also considering to incolate all "immunocompromised" people which include organ transplant recipients, people on cancer treatments, and those living with rheumatologic conditions, HIV and leukaemia, with additional doses of the Covid vaccines."As a long-term partner to the US government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country. Vaccines have been and will remain critical to protecting lives against this devastating disease," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer, in a statement on Thursday."These additional doses will help the US government ensure broad vaccine access into next year," he addedLast month, Pfizer and BioNTech had shared plans to provide the US government with 500 million doses of the companies' Covid-19 vaccine for donation to the world's poorest nations.Roughly 86 million people have been fully vaccinated with the Pfizer-BioNTech vaccine in the US as of Thursday, according to the US Centers for Disease Control and Prevention.The Pfizer-BioNTech Covid-19 vaccine has been authorised for emergency use by the US Food and Drug Administration (FDA), under an Emergency Use Authorisation (EUA) in individuals 12 years of age and older.Pfizer is also conducting clinical trials to evaluate the safety and efficacy of the vaccines in children under 12. The results for children aged 5 to 11 are expected in September, after which the company aims to ask the FDA to authorise emergency use.Results of the trial of the Covid jabs for children aged two to five-year-olds will likely come in October or November.--IANSrvt/in
Canberra, July 23 (IANS) Australia's medical regulator on Friday provisionally approved Pfizer's coronavirus vaccine for children aged 12 to 15 years.Health Minister Greg Hunt announced that the Therapeutic Goods Administration (TGA) has ruled that the Pfizer-BioNTech Covid-19 vaccine is safe for the age group, reports Xinhua news agency.It makes it the first coronavirus vaccine approved for individuals younger than 16 in Australia.Up until now, the Pfizer vaccine had only been approved for use in Australia for people aged 16 years and above.In a statement, the TGA said the decision to approve the vaccine for the age group was made after careful evaluation of clinical studies."Provisional approval for use in the 12-15 years age group has been made following careful evaluation of the available data supporting safety and efficacy, including clinical studies with adolescents 12 to 15 years of age," it said."The decision has been made on the basis of short term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment."Hunt said that conversations with the Australian Technical Advisory Group on Immunisation (ATAGI) about rolling out vaccines to vulnerable children were "well advanced"."What is more likely, on the early advice I have, is that they will fast track vaccines for 12-15 year-olds for the immunocompromised children, or those with underlying health conditions, and then they'll review the incoming data over the course of the next month on the general population," he told the media.So far there has been about 10.6 million coronavirus vaccine doses administered in Australia. Approximately 36 per cent of the adult population have received one vaccine dose and 14.9 per cent are fully inoculated.Since the onset of the pandemic, there has been a total of 32,427 confirmed cases of Covid-19 in Australia, while the death toll stood at 915.--IANSksk/
London, July 20 (IANS) A 61-year-old Caucasian man in the UK experienced facial palsy after each dose of the Pfizer-BioNTech Covid vaccine, suggesting a strong link between the jab and Bell's palsy, according to the doctors at the National Health Service.
Bell's palsy -- a facial nerve palsy of unknown cause, where muscles on one side of the face become weak or paralysed.
In the journal BMJ Case Reports, the doctors describe the first such case to be reported in the medical literature of two separate unilateral facial nerve palsies, occurring shortly after each dose of a Covid-19 vaccine.
The man had no previous history of facial nerve palsy, but had a high Body Mass Index, high blood pressure, high cholesterol and Type-2 diabetes. Both doses of the vaccine were administered to the left arm, reported the doctors.
The first episode of facial nerve palsy developed five hours after administration of the first dose and the second two days after administration of the second dose administered six weeks later.
Investigations at initial presentation to the emergency department were unremarkable, and the patient was diagnosed with Bell's palsy on both occasions, the doctors said.
The patient attended the emergency department after the first episode, unable to close his left eye properly or move the left side of his forehead and was diagnosed with Bell's palsy. Routine bloods and a CT head scan showed nothing of concern and he was discharged with a course of steroids, and the facial nerve palsy completely resolved.
The second episode was a more severe left-sided facial nerve palsy. The symptoms included dribbling, difficulty swallowing and inability to fully close his left eye. He went to the emergency department, where he was again prescribed a course of steroids. He was also referred to the emergency ENT (Ear Nose and Throat) clinic, which continued the steroids and referred him to ophthalmology, the doctors reported.
"We describe the first case of Bell's palsy occurring after each dose of any UK-approved Covid-19 vaccine. Single episodes of unilateral facial nerve palsies have been reported in clinical trials and in subsequent case reports. There has been no evidence, however, of an episode after each dose," said Dr Abigail Burrows, ENT, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.
"We also describe the earliest onset of symptoms from the timing of administration of the vaccine, further suggesting Bell's palsy was associated with the vaccine," she added. However the doctors noted that a causal relationship cannot be established.
The doctors report that his symptoms have greatly improved and the patient is almost back to normal.
Single episodes of unilateral facial nerve palsies were reported in the initial clinical trials of the three major Covid-19 vaccines approved for use in the UK -- Pfizer-BioNTech, Moderna and Oxford/AstraZeneca -- and there have been subsequent case reports.
In Phase-III trials, four cases of Bell's palsy were reported in volunteers who received the Pfizer vaccine compared with none in those who received the placebo vaccine, and three cases were reported in volunteers who received the Moderna vaccine compared with one in the placebo group.
Three cases of facial nerve palsy were also reported in volunteers who received the Oxford/AstraZeneca vaccine during clinical trials, and there were three cases in volunteers who received the placebo vaccine.
Jakarta, July 16 (IANS) Indonesia's Food and Drug Authority (BPOM) has issued an emergency use authorization (EUA) for the Pfizer Covid-19 vaccine amid a spike in cases as the more contagious Delta variant is spreading in the country, an official said."BPOM has issued the EUA for the vaccine produced by Pfizer and BioNTech with the mRNA platform," Xinhua news agency quoted the Authority's head Penny K. Lukito as saying at a virtual press conference on Thursday.Indonesia has an agreement to procure 50 million doses of Pfizer vaccine throughout 2021.The country has so far given EUA approvals to five Covid-19 vaccine producers, namely Sinovac, Sinopharm, Pfizer, Moderna and AstraZeneca.Indonesia recorded on Thursday 56,757 new cases, the highest since the pandemic hit the country for the first time in March last year, bringing the total tally to 2,726,803. The death toll stood at 69,210.--IANSksk/
Tel Aviv, July 13 (IANS) Israel has started administering a booster shot of Pfizer's Covid-19 vaccine to people with weak immune systems, the media reported. It is one of the first countries to globally approve a booster shot.The decision for the third jab comes as Israel is witnessing an outbreak of the highly contagious Delta variant, after being one of the first to fully inoculate more than 60 per cent of adults in the country.The Health Ministry will offer the third jab to immunocompromised patients, such as recipients of organ transplants, the Wall Street Journal reported.This is following evidence that the booster shot may increase such patients' antibody counts, according to a Health Ministry letter sent to Israeli healthcare providers, the report said.The Ministry said the recommended time between a second and third shot would be eight weeks, with a minimum gap of four weeks.While the booster shots are not yet rolled out for the general public, the government is, however, weighing the option.Israel is trying to halt a new outbreak of the Delta variant and has launched a campaign calling teenagers over 12 years old to get vaccinated.Although most reported cases have been mild or asymptomatic, there has been a steady rise in the number of infections.On July 11, Israel also signed a deal with Pfizer to receive a new batch of Covid-19 vaccines in August.In a statement at the start of the weekly cabinet meeting, Prime Minister Naftali Bennett said that "last night we closed a deal to bring forward the next shipment of vaccines to August 1", reports Xinhua news agency.He said that together with existing vaccine stocks, the new batch will ensure "from this moment, a continuous inventory of vaccines in Israel".Meanwhile, the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), last week, released a joint statement on vaccine boosters, saying that people who are fully vaccinated are protected from severe illness and death, including from emerging variants such as the highly contagious Delta variant."FDA, CDC, and NIH (National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary," said the statement.--IANSrvt/dpb
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