Tag: COVID vaccine

Categories : COVIDTags :

COVID Vaccines and Vaccination Certificates Sold on Darknet

On By ModernMedia

According to an article by BBC News, COVID vaccines and vaccination certificates are being widely sold on the darknet.

Prices can range from  $500 (R7500) and $750 for doses of the AstraZeneca, Sputnik, Sinopharm or Johnson & Johnson vaccines. Some even allow for emergency delivery with an overnight service. There are also fake vaccination certificates being sold for as little as $150.

Also known as the ‘dark web’, the darknet is a part of the internet that can only be accessed with specific browser tools. One such tool is Tor, a browser specially designed for anonymity.

Cyber-security company Checkpoint says that they have seen the number of adverts triple from when vaccines first become available, to 1200. The sources of the adverts appear to be the US, UK, Spain, Germany, France and Russia.

Oded Vanunu, head of product vulnerabilities research at Check Point told the BBC: “It’s imperative for people to understand that attempting to obtain a vaccine, a vaccination card or negative Covid-19 test result by unofficial means is extremely risky, as hackers are more interested in your money, information and identity for exploitation.”

Mr Vanunu also shared that,  as part of their research, his team purchased a Sinopharm vaccine dose from one of the vendors for $750, but are yet to receive it. His team believes that this particular vendor was a scammer, but others might be selling real vaccines.

Check Point is urging countries to protect their vaccine documentation by implementing a QR code system to make forgeries more difficult.

Source: BBC News

Categories : COVIDTags :

AstraZenaca Ineffective Against SA Variant in Early Trial

On By ModernMedia

In a phase Ib/II trial, the AstraZeneca vaccine was ineffective against both the South African SARS-CoV-2 variant or the wild-type virus.

In this South African trial, the vaccine’s overall efficacy versus mild-to-moderate COVID was 21.9% and efficacy against the B.1.351 variant was 10.4%.

Participants’ median age was 30, about 56% were men, and 71% were black. Almost 20% of participants were obese, 42% were smokers, and about 3% of those had underlying hypertension or chronic respiratory conditions. All were HIV negative. The median time between doses was 28 days.

Overall, 19 of 750 in the vaccine group (2.5%) and 23 of 717 in the placebo group (3.2%) developed mild-to-moderate COVID. 

In regard to the secondary outcome of testing effectiveness against the B.1.351 variant, the authors note that “the trial was powered for the primary objective of a vaccine efficacy of at least 60% in preventing COVID-19 of any severity, regardless of variants.”

Exploratory analyses found about 33.5% efficacy against COVID of any severity more than 14 days after the first dose. No cases of severe COVID were reported among the participants, but with the groups’ demographics, especially their relatively young age, it was unlikely that severe COVID would be observed in such a small trial.

Professor Shabir Madhi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit at Wits, said in a press release that the AstraZeneca results “threw a curveball” after the initial “euphoria” over the effectiveness of the first COVID vaccines. He nevertheless stressed that the AstraZeneca vaccine was still important in preventing hospitals being overrun with COVID patients.

Despite the disappointing results, Prof Madhi said these findings “need to be made in the context of ongoing global spread and community transmission of the B.1.351 variant”.

Source: MedPage Today

Journal information: Madhi SA, et al “Efficacy of the ChAdOx1 nCOV-19 Covid-19 vaccine against the B.1.351 variant” N Engl J Med 2021; DOI: 10.1056/NEJM2102214.

Categories : COVIDTags :

WHO and Health Experts Back AstraZeneca Vaccine

On By ModernMedia
Woman receiving an injection in the upper arm. Photo by Gustavo Fring from Pexels.

Although a number of EU countries have halted the use of the AstraZeneca vaccine, the company along with a number of health experts insist that it is safe.

AstraZeneca said in a statement on Monday that there were 15 deep vein thrombosis (DVT) events and 22 pulmonary embolism (PE) cases among 17 million people in the EU and UK who have received at least one AstraZeneca vaccine dose.    

“This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines,” the pharmaceutical company said.

The company pointed out that in the clinical trials, “even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60 000 participants enrolled.”

The European Medicines Agency (EMA) reiterated that there is no indication that the vaccine was responsible for these adverse events. The organisation is currently reviewing the vaccine, and more information is expected in its monthly safety report due during the week. They are currently scheduled to meet on Tuesday.

There are however concerns that slowing the pace of vaccinations will result in more lives lost and fuel vaccine hesitancy.

“I do worry that some people will not be able to differentiate between an unrelated or coincidental VTE [venous thromboembolism] occurrence (due to DVT/PE being so common in the general population) and a causative relationship,” Stephan Moll, MD, of the division of haematology at the University of North Carolina at Chapel Hill, said to MedPage Today.

WHO chief scientist Soumya Swaminathan, MD, noted that it has happened before: Norway early on raised concerns about deaths among the elderly getting vaccinated, but then clarified it was only the expected rate of death.

She pointed out that of the 300 million-odd doses of all COVID vaccines administered globally, not one death has been documented as having been caused by vaccination, “We do not want people to panic. We would for the time being recommend that countries continue vaccinating with AstraZeneca.”

Canada, meanwhile, has said that it will continue to use the AstraZeneca vaccine. The company is likely to seek emergency use authorisation from the United States for its jab when it clears its Stage III clinical trials in that country.

“This does not necessarily mean these events are linked to vaccination, but it’s routine practice to investigate them,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus at a press briefing Monday. “It shows that the surveillance system works and effective controls are in place.”

Source: MedPage Today

Categories : COVID VaccinesTags :

US Rollout of Johnson & Johnson Vaccine As It Gets FDA Approval

On By ModernMedia

Johnson & Johnson’s single shot COVID vaccine is set to roll out in the US after its approval, but concerns linger as to the public’s perception of its relative effectiveness.

The vaccine received an emergency use authorisation (EUA) on Saturday from the FDA, and received approval from the CDC the following day. On Sunday night White House officials stated that distribution of 3.9 million doses of the J&J vaccine would begin immediately, with J&J expecting to deliver some 16 million more doses by the end of March. These vaccines will be allocated proportionally, as per the procedure for Pfizer/BioNTech and Moderna vaccines.

At a Saturday media briefing, acting FDA Commissioner Janet Woodcock, MD, reiterated issues raised by the FDA advisory committee, that the J&J product’s lower efficacy number (70% vs 95%) may cause people to think it is less effective than the alternatives. She said that wasn’t necessarily so, urging Americans to “take the vaccine they are able to access.”

“All these vaccines meet our standards for effectiveness. They were not studied in head-to-head trials, so [they’re] difficult to compare … due to differences in development programs,” she said. (Preventing moderate-to-severe COVID illness was the J&J endpoint, whereas in the Pfizer and Moderna studies the endpoint was all symptomatic COVID.)

“We need to be clear on our messaging regarding comparisons with other vaccines,” said Jason Goldman, MD, of the American College of Physicians. “As a primary care physician, many of us are eager to vaccinate” patients and this vaccine will be “helpful in achieving that goal.”

Macaya Douoguih, MD, of J&J’s Janssen unit where the vaccine was developed, talked about the potential advantages of a one-dose vaccine, referencing the company experience with the Ebola vaccine

“For an outbreak setting, a single dose has a tremendous advantage in terms of being able to rapidly roll out mass vaccination” without the complexity of following up for a second dose, she said.

Dr Douoguih addressed the company’s planned two-dose study, saying that while a two-dose regimen might be “more immunogenic and lead to durable efficacy,” she thought there was room for both options. The two-dose option would be preferable in an ‘everyday’ COVID setting. The company was trying to enroll 16-17 year olds for additional data in a study starting next week, Dr Douoguih said.

The CDC researchers discussed preliminary data on asymptomatic infection, which assessed seroconversion between days 29 and 71. Those data showed vaccine efficacy against seroconversion was 74% (95% CI 48%-87%), but the CDC urged caution as the data was only preliminary.

“Our level of confidence in asymptomatic infection is tempered by low numbers and that is important for us to remember,” said Advisory Committee on Immunization Practices committee member Sarah Long, MD, of Drexel University College of Medicine in Philadelphia. “I appreciate the workgroup concluding the confidence is not that high.”

Source: MedPage Today

Categories : COVID VaccinesTags :

Why It’s So Hard to Compare Vaccines

On By ModernMedia

While the world is looking to vaccinations to end the COVID pandemic, a MedPage Today article explains that even with vaccines that have high efficacy, ending transmission is not guaranteed, and there are a lot of differences between simple figures like 94% for Pfizer and 95% for Moderna vaccines.

Firstly, asymptomatic cases are not tracked, simply because assembling tens of thousands of people for a clinical trial is a monumental logistic task, and in the current pandemic, a race against time.

Internist Jeffrey Carson, MD, who managed the Johnson & Johnson COVID vaccine trial’s site at Rutgers University in New Jersey, explained to MedPage Today that it would be difficult but not impossible to create a vaccine trial that provided rapid data about asymptomatic cases.

“You might have people swab themselves every couple days, or every week. You’ll be picking up a lot of disease that way, and you’ll be able to see if the vaccine prevents asymptomatic disease,” Dr Carson said. The current Novavax trial, for example, only asks participants to test themselves for COVID with provided swabs if they believe they are developing symptoms. The Novavax vaccine had also prompted alarm as it was only 49.4% effective against the B501Y.V2 variant, its efficacy reduced by the low rate of protection for HIV positive participants.

The New York Times explained that efficacy is merely how well a vaccine did in a clinical trial, effectiveness is how well it performs in the real world.
Vaccine statistics are difficult even for medical experts to grasp. An infectious diseases expert wrote in a letter to the Lancet explaining that they had misunderstood what 94% to 95% efficacy means for Moderna and Pfizer vaccines and asymptomatic spread.

“It does not mean that 95% of people are protected from disease with the vaccine — a general misconception of vaccine protection.” Instead, it “means that in a population such as the one enrolled in the trials, with a cumulated COVID-19 attack rate over a period of 3 months of about 1% without a vaccine, we would expect roughly 0.05% of vaccinated people would get diseased [with symptomatic infections]. … Accurate description of effects is not hair-splitting; it is much-needed exactness to avoid adding confusion to an extraordinarily complicated and tense scientific and societal debate around COVID-19 vaccines.”

A further problem for scientists is that viral diseases can spread to people unaware that they are infected, something they are still working on understanding. “It makes a lot of sense for survival of the invaders, if you think about it. Humans who feel unwell are not going out to meet up with others, but ones who feel fine will continue along with their daily schedules, allowing the infection to spread,” Bryn Boslett, MD, an infectious disease physician at the University of California San Francisco, told MedPage Today.

Regardless of how well vaccines interrupt the transmission of COVID, it’s important that mask-wearing, social distancing and disinfecting habits are maintained.

“One major worry going forward is that vaccinated people will change their behaviour and stop taking COVID-19 precautions,” Dr Boslett said. “It’s very tempting to do so, very understandable. However, the stars are not yet aligned for us to go back to ‘normal.’ There is still a lot of COVID-19, and most of us are still vulnerable. We need to continue to focus on behavior to reduce new cases of COVID-19.”

Source: MedPage Today

Categories : COVID General InterestTags :

The Second Vaccine Dose Can Hit Hard

On By ModernMedia

The scuttlebut among healthcare workers is that the second dose of a COVID vaccine hits much harder than the first – unless you’ve had COVID, in which case the first is equally as bad.

TJ Maltese, DO, a neurologist in private practice on Long Island in New York state, was fine with the first dose of the Moderna vaccine but was flattened by the second one.

Dr Maltese got his second jab on a Friday at 4:30 pm. Within two hours his arm was sore. Overnight, he developed flu-like symptoms, and on Saturday experienced chills and body aches, with a lingering fever. He could have pushed through if he’d had to work, he said, but he rode out his symptoms on his couch with the help of the occasional painkiller.

By 9 pm on Saturday evening, Dr Maltese started to feel better, getting a good night’s sleep and on Sunday was fine again.

“I know plenty of people with minimal symptoms after the second dose, so it’s not definite you’ll feel side effects,” he wrote in a Facebook post. “But be prepared for the possibility.”

Immunology and the phase III clinical trial data from the vaccine backs up the view that the second dose is worse, and some hospitals have even altered their scheduling to allow time for recuperation after the second dose. Adverse reactions to the BCG vaccine in Brazilian school children, for example, have been reported to be common with the second dose, though still rare.  

Immunologists and infectious disease experts interviewed by MedPage Today and who shared their second-dose experiences said it’s not unexpected that second-dose reactions are more intense than the first. Typical reactions to the COVID vaccines include fever, headache and fatigue as the immune system responds to a vaccine’s antigens.

“The first time the immune system comes into contact with something, it’s getting primed,” said Purvi Parikh, MD, an immunologist at NYU Langone Health in New York City. “That goes for everything, from vaccines to allergies. It’s rare on the first time to have a strong reaction. After that, the immune system recognizes it, so you have a much stronger reaction.”

“We saw it in the trials, so it’s really not surprising,” Parikh added. “Now we’re seeing it in real time as the vaccines are being rolled out.”

More adverse effects were reported after the second dose in both Pfizer’s and Moderna’s phase III trial data. For Moderna, the rates were 54.9% versus 42.2% for placebo after the first dose and 79.4% versus 36.5% for placebo after the second dose.

Stanley Weiss, MD, an infectious disease specialist and epidemiologist at Rutgers New Jersey Medical School, told MedPage Today that because his institution served as a Moderna trial site, the primary investigator was able to give an early update on what to expect following vaccination.

“They said there was a very high rate of fatigue after the second dose, so we encouraged administrators … to figure that many healthcare workers getting the vaccine might not be well enough to work the day after the second dose,” Dr Weiss said.

Drs Weiss and Parikh both experienced a stronger response to the second COVID dose. 

Zubin Damania, MD, aka ZDoggMD, said he was knocked out by the second dose of Moderna vaccine, joking on his show that, “I couldn’t sleep, I had a fever, rigors, body aches, a headache — full-on man-flu.”

Paul Offit, MD, said that he also experienced fever and fatigue after taking the second dose of the Pfizer vaccine.

“That reaction is less common in people over 65, and I’m over 65, so I’m thinking I’m not going to suffer that, but I did,” Dr Offit said.

Older people are not expected to have as intense a reaction due to their weaker immune systems. According to Dr Parikh, “The idea is that their immune system is not as robust as a young person’s.”
The same immunological underpinnings of why reactions to the second dose are worse also apply to those who’ve had COVID.
Victoria Arthur, MD, of Lexington Pediatrics in Massachusetts, had suspected she had contracted COVID in March 2020 but could not prove it. When she received the Moderna vaccine, she felt much worse than her colleagues.

“How I felt was how everyone else was describing their second vaccine,” Dr Arthur told MedPage Today. Within three hours of her jab, she was suffering from a headache, neck pain, and cognitive fog. She awoke at 3am with nausea and stomach cramps, and spent the whole of the next day in bed. 

“I’m always grateful when I have a reaction, that means the body is doing its thing,” she said. “I’m very fortunate to have been given the vaccine, so any side effect is worth it.”

In spite of the side effects, these health care professionals all expressed gratitude at having been vaccinated.

Dr Weiss said that people shouldn’t be discouraged by the side effects from the second dose and not get vaccinated: “The benefits greatly overwhelm the risk of side effects. It’s not a reason to delay.”

Source: MedPage Today

Categories : COVIDTags :

Reckless to Discard AstraZeneca Vaccines, Says Prof Madhi

On By ModernMedia

Professor Shabir Madhi of Wits University says that it would be reckless to simply abandon South Africa’s stock of AstraZeneca vaccine doses, even after a small trial showed it to have minimal effect against the local variant.

One million doses of AstraZeneca vaccine had been scheduled for rollout, but that plan has been put on hold after preliminary results showed that it conferred minimal effectiveness against mild-to-moderate infections by the dominant 501Y.V2 strain in South Africa. 

Madhi said that scientists needed more time to go through the data, said Madhi.

“I think it would be highly reckless for us to discard the vaccine. We paid a high price for it and so the vaccines do have a role in protecting from severe disease. I think an important feature in all the vaccines is that generally, vaccines work much better in preventing severe disease.”

There is already a closing window of opportunity, since it was recently discovered that the first batch of one million doses received from the Serum Institute of India would be expiring in April.

Madhi said that there were other options to put the vaccine to good use.
“If we’re strategic in terms of the rollout, we might still be able to get the vaccine used, not two doses per individual but at least a single dose and we could possibly follow it up then with another vaccine and a few vaccines that might come online in the next two or three months.”

In an interview with the BBC, he said that the disappointing results of the trial had not been able to show the effectiveness against severe COVID, as the sample size was too small and too young, with an average age of 31, but that it might still have a protective effect in different age groups. “There’s still some hope that the AstraZeneca vaccine might well perform as well as the Johnson & Johnson vaccine in a different age group demographic that I address of severe disease,” he said.

Source: Eyewitness News

Categories : COVIDTags :

UK to Look at Mixing of Different Vaccines

On By ModernMedia

The UK is launching a trial to explore the mixing of vaccines can be combined. Some, like Russia’s Sputnik vaccine, already combine two different types of vaccines, but these were specifically designed and tested to work together. 

Current guidance in the UK says that anyone who receives a Pfizer-BioNTech or Oxford-AstraZeneca vaccine dose should get the second dose of that same vaccine. Only in exceptional circumstances such as not knowing what vaccine was given will a different vaccine be administered.

The main aim was to enhance logistical flexibility. The Oxford/AstraZeneca, Johnson & Johnson and Novavax vaccines can all be stored at normal refrigerator temperatures, while the Moderna vaccine must be stored at -20C, within normal freezer range, and Pfizer/BioNTech’s vaccine needs an ultra-cold -70C. Not requiring a second dose of the same vaccine could ease up storage requirements. 

However, with previous vaccines, mixing different vaccine types worked and even strengthened their overall effectiveness. Some Ebola immunisation programmes, for example, combine two different vaccines to achieve greater protection.

The trial will comprise some 800 participants aged 50 or older, receiving a combination of Oxford/AstraZeneca and Pfizer/BioNTech in either order.

Some vaccines that work by using a virus to deliver the antigens, and there is some evidence to suggest that the immune system starts to focus on the viral delivery system instead of the antigen. Thus, combining vaccines will keep the immune system’s attention on the antigens.

Chief investigator, Prof Matthew Snape from the University of Oxford, said the “tremendously exciting study” would provide critical information for vaccine rollouts.

Animal studies have shown “a better antibody response with a mixed schedule rather than the straight schedule” of vaccine doses, he said.

“It will be really interesting to see if the different delivery methods actually could lead to an enhanced immune response [in humans],” he said, “or at least a response that’s as good as giving the straight schedule of the same doses”.

Source: BBC News

Categories : COVIDTags :

Pfizer Vaccine 90% Effective After a Single Dose

On By ModernMedia

A study from the University of East Anglia (UEA) reported that the Pfizer vaccine provides “very high” protection after a single dose.

The researchers drew on Israeli data, where the vaccine had been widely administered, and found that the vaccine was 90% effective at 21 days after the initial dose. This supports the plan that the UK and other nations have of delaying a second dose to achieve maximum coverage. However, they also noted that infection rates increased eight days after the first dose, which they attribute to people becoming less cautious as a result of the vaccination. The study is available on the medRxiv preprint server, and has not been peer reviewed, as it is a rapid response to the ongoing COVID pandemic.

Lead researcher and COVID expert Prof Paul Hunter, from UEA’s Norwich Medical School, said: “A second dose of the Pfizer vaccine would normally be given 21 days or more after the first to top up and lengthen the effect of the first dose.

“But here in the UK, the decision was made to delay the timing of the second injection until 12 weeks after the first.

“The logic behind this is to protect more people sooner and so reduce the total number of severe infections, hospitalisations, and deaths.

“But this decision caused criticism from some quarters due in part to a belief that a single injection may not give adequate immunity.”

Prof Hunter explains the motivation for the study was previous flawed research on the Pfizer vaccine, also using Israeli data. But the study did not consider effectiveness past day 18.

The researchers observed that case incidence rose up til day eight by which time it had doubled, then fell. Prof Hunter said: “We found that the vaccine effectiveness was still pretty much zero until about 14 days after people were vaccinated. But then after day 14 immunity rose gradually day by day to about 90 percent at day 21 and then didn’t improve any further. All the observed improvement was before any second injection.

“This shows that a single dose of vaccine is highly protective, although it can take up to 21 days to achieve this.”

Although the vaccine’s effectiveness beyond this is not known, it still supports the UK’s decision to space out vaccine doses, Prof Hunter concluded.

Source: Medical Xpress

Journal information: “Estimating the effectiveness of the Pfizer COVID-19 BNT162b2 vaccine after a single dose. A reanalysis of a study of ‘real-world’ vaccination outcomes from Israel” is published on the medRxiv pre-print server: www.medrxiv.org/content/10.110 … 021.02.01.21250957v1

Categories : COVIDTags :

New Single-dose Intranasal Vaccine Shows Promise

On By ModernMedia

A new, single dose intranasal vaccine has shown ability to protect Macaques against COVID, as reported in a preprint article on bioRxiv. If it proves effective and safe in humans, it could be a radically effective and simple to administer vaccine against COVID.

Currently, most COVID vaccines are administered intramuscularly and require two doses. However, after immunisation, an infected person can still shed the virus from the upper airways because they do not have local or mucosal immunity, as demonstrated by intramuscular vaccination in non-human primates.

The SARS-CoV-2 virus enters the target the host cell by the spike (S) protein antigen locking on to the cell’s angiotensin-converting enzyme 2 (ACE2) receptor. Thus, the S protein is a critical target for vaccine development.The researchers developed the new vaccine uses a chimpanzee adenovirus which expresses the S protein (ChAd-SARS-CoV-2-S). The chimpanzee adenovirus (also used in the AstraZeneca vaccine) is ideal as an antigen carrier for vaccines as the prevalence of neutralising antibodies against it is low. 

In the researchers’ previous work, the vaccine had been administered intranasally to mice with expressed human ACE2 receptors, producing a detectable immune response. The researchers then moved experimentation on to macaques, administering a single intranasal dose of vaccine, followed by intranasal and intrabroncheal challenge with SARS-CoV-2.

A detectable immune response was detected by the presence of anti-S, anti-RBD, and neutralising antibodies, as well as T cell responses. Viral RNA loads measured by nasal swabs were lower in immunised animals, with only one having detectable virus presence, compared to four of six control animals. These results suggest that local infection is prevented, with reduced viral RNA levels and faster viral clearing. 

Infection was also measured in broncheal alveolar lavage fluid (BALF)At day seven, immunised animals showed lower viral DNA than controls, corresponding to increased neutralising antibody levels.

Administering the vaccine intranasally could allow protection of the local and surrounding tissues, while reducing disease severity and spread to others. However, the lack of severe pathologies in both sets of animals means that no conclusions can be drawn about the vaccine’s effectiveness in preventing against COVID.

Further research is required to compare the effects of intramuscular and intranasal administration of the vaccine, and the work is yet to be peer reviewed.

Source: News-Medical.Net

Journal information: Hassan, A. O. et al. (2021). A single intranasal dose of chimpanzee adenovirus-vectored vaccine protects against SARS-CoV-2 infection in rhesus macaques. bioRxiv preprint. doi: https://doi.org/10.1101/2021.01.26.428251. https://www.biorxiv.org/content/10.1101/2021.01.26.428251v1