Tag: COVID vaccine

Categories : COVIDTags :

Ramaphosa to Take Delivery of SA’s First Vaccine Doses

On By ModernMedia

President Cyril Ramaphosa will take delivery of the first million doses arrives in South Africa at OR Tambo airport on Monday.

Ramaphosa will be accompanied by Deputy President David Mabuza, Health Minister Zweli Mkhize and the High Commissioner of India. After the vaccine has been received, it will be taken to cold storage for and undergo technical processing and quality testing.

Acting spokesperson for the Presidency, Tyrone Seale, said: “The arrival of the fist consignment at OR Tambo International Airport marks the start of the vaccine roll-out, which President Ramaphosa describes as the largest and most complex logistical vaccine undertaking in South Africa’s history.”

The AstraZeneca doses were produced by the Serum Institute of India, and healthcare workers will be the first to be vaccinated, with essential workers second on the list. However, the Department of Health has suggested that politicians (who are classified as essential workers) may be the first to receive the vaccine, in order to reassure the public and encourage vaccine uptake. An additional 500 000 doses are to be delivered in February.

There are fears that current vaccines are less effective against the B1.351 “South African” variant. The Novovax vaccine has been shown to have slightly less than 50% effectiveness in South African trials, due to the variant and the prevalence of HIV in the population. Johnson & Johnson’s vaccine, which is set to be produced locally by Aspen, is around 57% effective in South Africa. These are about what is achieved with annual flu vaccines, which are 40-60% effective. The AstraZeneca AZD1222 vaccine developed in concert with Oxford University have been shown to be 70% effective in clinical trials, although this was prior to the widespread emergence of COVID variants. However, it is possible to adjust vaccines to to deal with the new variants, with Dr Anthony Fauci saying that this reduced vaccine effectiveness against variants is a “wake-up call”.

The Azstra Zeneca vaccine uses a non replicating viral vector to deliver genetic information to cells, instructing them to produce the spike protein of the SARS-CoV-2 virus to train the immune system to recognise it and build immunity. It requires two doses administered four weeks apart, and unlike many other vaccines, does not require storage at extremely cold temperatures – only requiring normal refrigeration at 2° to 8°C.

Source: Eyewitness News

Categories : COVID HIVTags :

Novavax COVID Vaccine only 49.4% Effective in SA

On By ModernMedia

On Thursday, Novavax announced that its vaccine was 89% effective, according to its UK trials which had 15 000 participants. However, its SA trials showed a much lower effectiveness of 49.4%, believed to be caused by the SA COVID variant B.1.351 (aka 501.V2). 

The company conveyed the information in a press release, with a detailed journal publication still to come. The SA trial had 4400 participants, and the observed protection varied depending on HIV status. In people who were HIV negative, the vaccine conferred 60% protection. If the vaccination trial included a representative proportion of HIV positive adult South Africans, it may mean that its effectiveness for this vulnerable segment is very low.

“The higher efficacy of the vaccine in the UK than in South Africa is because the variants circulating in SA are less sensitive to vaccine induced immune responses,” said Professor Shabir Madhi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits, and principal investigator in the Novavax COVID vaccine trial in SA.

“Nevertheless, the 60% reduced risk against Covid-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally. This is the only Covid-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa.”

Novavax is pressing ahead with a trial involving 30 000 participants in the United States and Mexico, and has shared data with the UK’s pharmaceutical regulator. It is not clear whether the data from the US and Mexico trial will be required before the vaccine receives approval there. Meanwhile on Friday, the Johnson & Johnson vaccine developed by its subsidiary Janssen has been shown to be 66% effective. It is a single dose vaccine with minimal refrigeration requirements, making it very important for the logistical challenge of vaccinations in developing countries. Since Aspen would be producing some of the doses locally, the SA government had been in talks with Johnson & Johnson to secure some of those vaccines for SA use. However, there are signs that it too is less effective against the B.1.351 variant.

Source: Business Insider

Categories : COVID Medical Industry VaccinesTags : 1 Comment

Johnson & Johnson is Behind on Vaccine Production

On By ModernMedia

Despite releasing promising data on its COVID vaccine, Johnson & Johnson may fall up to two months behind on its vaccine production schedule, Politico reported. The company is still committed to releasing the trial data on its 45 000 participants by the end of January to pave the way for approval.

If approved, as seems likely, the vaccine would be extremely beneficial for vaccination efforts as it would only require a single dose to confer protection and also would not require sub zero refrigeration, greatly simplifying vaccination efforts.

The company’s effort is part of the Operation Warp Speed initiative to vaccinate the US population as fast as possible, with a goal of vaccinating 80% of the country’s 330.7 million population by the end of June. The previous goal to distribute 20 million doses by the end of 2020 had already fallen short owing to insufficient production.

The co-director of Operation Warp Speed, Moncef Slaoui, hinted at a production slowdown, telling the media that the company was expecting to produce “single-digit million” doses by the second half of February. “We’re trying to make that number get as close to a double-digit number as possible, and then a larger number in March and a much larger number in April,” he added.

Johnson & Johnson had previously made a pledge to deliver 12 million doses by the end of February and as many as 100 million by June.

Despite the delay, there is good news in that initial data from 400 participants shows that the vaccine is safe and has a 90% efficacy in establishing antibodies, with immunity for most subjects established 29 days after the shot and lasting at least 57 days. Adverse reactions were reported to be be mild, and younger subjects were more likely to report them, with one subject experiencing a brief, mild fever.

Source: Politico

Categories : COVIDTags :

SinoVac’s Vaccine 50.4% Effective in Brazilian Trial

On By ModernMedia

The vaccine from Chinese pharmaceutical company Sinovac is only 50.4% effective, according to updated data from a Brazilian trial.

Sinovac’s vaccine uses inactivated virus particles to trigger an immune response. Both the Sinovac vaccine and the Oxford vaccine have requests for emergency use in Brazil which are expected to soon to be granted.

This new number is lower than what was suggested last week by Butantan Institute, which distributes 65% of the vaccines in the country, and is running the trials. They had reported that the vaccine was 78% effective in “mild-to-severe” COVID cases, but reported on Tuesday that this number had not included cases with very mild COVID symptoms.
Interim results from late stage trials in Turkey and Indonesia reported that SinoVac was 91.25% effective and 65.3% effective, respectively. 

All of these discrepancies show just how hard to it is to compare the effectiveness of vaccines as measured by different trials in different countries. Other countries only count cases of COVID which generate obvious symptoms; including cases which are almost asymptomatic will lower the reported effectiveness.

However, there has been concern that the Chinese vaccine trials have not been subject to the same level of scrutiny and transparency as those in the West. Conversely, claims that the Russian Sputnik vaccine has a 95% effectiveness have been met with some suspicion, especially given its haphazard roll-out, which combined a trial (now cut short) with a release for emergency use. 

Source:BBC News

Categories : COVID UncategorizedTags :

Pfizer/BioNTech Vaccine Effective against SA and UK COVID Variants

On By ModernMedia

Amidst concerns that the SARS-CoV-2 virus might escape the protection of vaccines, initial results from new research shows that the Pfizer/BioNTech vaccine remains effective against the South African and UK COVID variants.

The new variants, which are much more transmissible, had created concern that due to mutations in their structure, they might not achieve the full protection of the current vaccines, especially in the SA variant.

However, this is a preliminary study that has not yet been through a peer review process, and the worrying E484K mutation in the South African strain which has been shown to reduce antibody recognition has not been tested on – that is still to be done.

Using blood samples from 20 individuals who had received the Pfizer/BioNTech vaccine, antibodies in the samples successfully defended against the virus variants. The results were made available on the bioRxiv site. Pfizer chief scientific officer Dr Philip Dormitzer said that “it was a very reassuring finding that at least this mutation, which was one of the ones people are most concerned about, does not seem to be a problem” for the vaccine.

However, should future mutations of SARS-CoV-2 achieve viral escape from the vaccines, the necessary adjustments to counter this could be made to the vaccines within a matter of weeks. Dormitzer said that this work was only the start “ongoing monitoring of virus changes to see if any of them might impact on vaccine coverage.”

Source: Medical Xpress

Categories : UncategorizedTags :

SA Currently Without Access to Pfizer/BioNTech’s “90% Effective” Vaccine

On By ModernMedia

Despite taking part in a recent successful vaccine trial, South Africa does not have guaranteed access to it. South Africa missed out on the first deadline to take part in the WHO-backed COVAX scheme, but is currently understood to be negotiating with COVAX and manufacturers.

Early results from the Pfizer/BioNTech two-dose vaccine’s trial showed a 90% reduction in symptomatic COVID cases over placebo, and caused a media sensation. 800 South African participants are to take part in the trial.

“This is a massive development. It’s very exciting, and the interim results are very promising. It leaves me with lots of hope as this could pave the way for a vaccine to be developed before the end of the year,” said Dr Essak Mitha, the head of the South African arm of the clinical trial who is a clinical trial specialist and owner of Newtown Clinical Research in Johannesburg.

The news was met with some caution; the decision to announce the news via a company press release instead of a peer reviewed article was controversial.

The BioNTech vaccine is based around messenger RNA (mRNA). The mRNA in the vaccine carries viral proteins, and once introduced into the body’s cells, instructs them to make copies of viral proteins. One such protein coded for is the infamous “spike” protein that SARS-CoV-2 uses to latch onto cells, and which contributes to its high infectivity. 

Source: AllAfrica

Categories : UncategorizedTags :

Aspen Shifts to SA Production of COVID Vaccines

On By ModernMedia

Aspen Pharmacare has secured a deal to manufacture the Johnson & Johnson COVID vaccine, in an effort to adapt to the pharmaceutical market. 

Elective surgeries being deferred due to the pandemic has reduced demand for certain medications, and the company withheld dividends for the second year running in September. However, the company does produce some medications which are currently in demand due to COVID.

Dexamethasone, one of the medications Aspen has the rights to produce, is a key treatment for COVID patients, which according to a study done in June, reduces mortality by 30%. Colchicine is another medication used to treat COVID, normally used for gout.

Tavros Nicolaou, a senior Aspen executive, said in an interview: “In February, we looked at how we best respond to this looming disaster facing us and we split it into three buckets — what we can do at a therapeutic level, what can we do at a vaccine level and what can we do to generally help society.” This positioned them “globally as a company that had a multifaceted response to this pandemic.”

The pharmaceuticals company has invested R3 billion in a Port Elizabeth plant to manufacture the Johnson & Johnson COVID vaccine at a rate of 300 million per year, which will help supply the rest of Africa. The need for local COVID vaccines may come sooner rather than later.

Despite peaking in July, the country’s COVID pandemic is not yet over with at least two provinces seeing increases in cases again, while on the horizon a second surge is expected in January.

Source: Moneyweb

Categories : COVID VaccinesTags :

Questions Raised over Oxford’s Unusual Vaccine Regimen

On By ModernMedia

The recent announcement of the Oxford’s and AstraZeneca’s vaccine trial being 70% effective up to 90% effective has raised some pointed questions.

The trial had two treatment arms, one receiving two full doses of the AZD1222 vaccine and a half dose plus a full dose, with the doses being administered 28 days apart. The “half dose then full dose”  treatment arm reported the 90% protection. The problem was that the trial was never meant to have such an arm. 

It was noticed that some participants were only receiving a half dose because they were experiencing fewer effects than expected such as arm pain and headache. This was subsequently corrected so that they would still receive the full dose on the second administration.

Of particular concern is that the “90% effectiveness” is based on a much smaller subset of the trial participants, with a correspondingly higher statistical uncertainty. So much so that there is statistical overlap with their lower effectiveness of 62% quoted for the two full doses. Furthermore, the participants were from the initial stages of the vaccine trial, where they were aged 18-55 and therefore have little applicability to the results of the main trial which included older age groups as well. 

The details of exactly why the half-measure doses came to be administered in the first place have not been revealed by Oxford or AstraZeneca. Meanwhile in the US, a Phase III of the trial is being rolled out with 40 000 participants, and the “half dose then full dose” regimen may be included – however, uncertainty about it and whether it isn’t a statistical fluke will have to be cleared up first.

Source: Ars Technica

Categories : COVIDTags :

China in discussion with WHO over possible use of its vaccines worldwide

On By ModernMedia

Despite not having clinical trials not being completed, essential workers in China have been given Chinese-developed vaccines, writes the Daily Maverick. The World Health Organisation (WHO) had reportedly held the first talks aimed at getting the Chinese COVID vaccine. Socorro Escalate, WHO’s coordinator for essential medicines and health technologies in the Western Pacific region, said:

“Potentially through this emergency use listing the quality and safety of these vaccines and efficacy could be assessed. ..and then this could be made available for our licensees.”

The Daily Maverick continues:

China has at least four experimental vaccines in the final stage of clinical trials – two are developed by state-backed China National Biotec Group (CNBG), and the remaining two are from Sinovac Biotech and CanSino Biologics respectively.

They are tested in such countries as Pakistan, Indonesia, Brazil, Russia and the United Arab Emirates.

Last month, the UAE authorized the emergency use of a CNBG vaccine, the first international emergency clearance for one of China’s vaccines, just six weeks after human trials began in the Gulf Arab state.

Philippines President Rodrigo Duterte said last month it would prioritise China and Russia in his country’s global shopping for a vaccine. 

Categories : COVIDTags :

Activists to Pressure SA Government over COVID Vaccine

On By ModernMedia

With the recent news that Pfizer’s and Moderna’s vaccines both have over a 90% efficacy, and air cargo carriers are standing ready to transport them, concerns are mounting that South Africa, with no deals to access vaccines, will be left out in the scramble by richer countries to secure vaccines.

Mark Heywood, executive director of Section27 and a veteran activist, said: “Now that vaccines are becoming available, our government must use all its powers to ensure that people in South Africa have equal access. Neither price nor patents should be an obstacle, and government must start now to think about the systems that will be needed to ensure the smooth distribution of the vaccine, starting for those with the highest risk of Covid-19.”

Dr Anthonet Koen, principal investigator at a COVID vaccine trial site, said: “It’s important that we get a vaccine that’s right, especially for South Africa. We often get overseen and get left behind when it comes to life-saving treatments. If you think about HIV, we were last in line to get access to antiretrovirals, and we don’t want that to happen.”
Koen dispelled any possibility of a vaccine being available before the year is out. “We need to be realistic about this… but hopefully within the first quarter of 2021 we will have something.”

Health Minister Zweli Mkhizi reiterated that there was no vaccine for now, “so we need to adhere to containment measures”.

Not only the vaccine’s acquisition but its logistics for distribution must be taken into account. Economist Mike Schussler said, “The entire supply chain will have to be considered. What we know is that if we had to do half of the South African population it would cost about R40  billion, and that’s highly problematic and unaffordable so we have to think strategically about this.”

Source: IOL