Tag: Johnson & Johnson

Categories : COVIDTags :

Department of Health COVID Vaccine Rollout Phase 2 Outlined

On By ModernMedia

The Department of Health’s COVID vaccine rollout has been fleshed out in a presentation, including details on how the vaccines will be distributed, and the jobs earmarked for the shots.

A presentation from the department indicates that the government has secured around 51 million vaccine doses, with 20 million from Pfizer and 30 million from Johnson & Johnson (J&J). However, it is unclear how the current pause in J&J administration in South Africa due to concerns about rare blood clots will affect immunisation schedules.

However, health minister Dr Zweli Mkhize announced that South Africa has secured a further 10 million Pfizer vaccines.

“We can now guarantee that the number of people that will be vaccinated with Pfizer has increased from 10 to 15 million,” he said.

With the 30 million of the single-dose shots from J&J, the current planned rollout will cover about 45 million South Africans.

Dr Mkhize said that both the Pfizer and J&J agreements cost around $10 (R145) per vaccine, with non-refundable clauses.

“The agreements state that down-payments that have been made in advance by the department shall not be refundable by the manufacturer to us in any circumstances. This is another onerous term that we had to settle for,” Dr Mkhize told the committee.

Meanwhile, government was sent an email from J&J, which stated that the company will not sign off the 20 million doses until they receive a letter from the Trade, Industry and Competition Minister, expressing support for the local investment that they made in Aspen Pharmacare.

“We’ve been taken aback by this, as there are clauses in the agreement that express this support and acknowledge that this production will not just be limited to South Africa and the continent, but also targeted for the global market,” said Dr Mkhize.

The department indicated that the Pfizer vaccine will likely go to major metropolitans due to its larger pack size and refrigeration requirements, while the J&J vaccine with its less stringent refrigeration needs would be allocated to rural areas.

South Africa’s Phase 2 of the vaccine rollout is planned to begin in May and run until October, with essential workers over 40 and the elderly to be targeted in the programme. This is to include a focus on old age homes and care facilities, plus identifying those with co-morbidities.

The department provided an overview of occupations covered under the vaccine rollout, to include, among others, the police, army, social and municipal workers, and faith and traditional leaders. Private sectors could include mining, retail, transport, and manufacturing.

Source: BusinessTech

Categories : COVIDTags :

FDA and CDC Justify J&J Vaccine Pause

On By ModernMedia

FDA and CDC officials recommended pausing administration of the Johnson & Johnson COVID vaccine “out of an abundance of caution,” and mainly for the benefit of clinicians to respond to associated serious events.

This comes after six cases of cerebral venous sinus thrombosis (CVST) combined with thrombocytopenia were reported in the US, all among women ages 18-48. With approximately 6.8 million doses administered in the U.S., it suggests a one-in-a-million risk. 

J&J has halted distribution of its vaccine in Europe, reportedly taking officials there by surprise. South Africa has also paused the vaccine rollout.

At a media briefing, when asked whether pausing administration of the vaccine was an “overreaction,” Acting FDA Commissioner Janet Woodcock, MD, said the aim was to provide “time for the healthcare community to learn what they needed about how to diagnose, treat, and report” such events.

FDA’s director for the Center for Biologics Evaluation and Research, Peter Marks, MD, PhD, noted that the condition involves a rare blood clot for which heparin or related anticoagulants is not the standard treatment.

“The issue with these types of blood clots is if one administered standard treatment, one can actually cause tremendous harm or the outcome can be fatal,” he said. “One needs to make sure providers are aware if they see people with low blood platelets or blood clots, to inquire about recent vaccination and act accordingly.”

The background rate of CVST is 2-14 per million in the setting of a normal platelet count, but thrombocytopenia together with abnormal clotting makes it a “pattern.” CVST symptoms also include severe headache, abdominal pain, leg pain, and shortness of breath.

Marks noted that vaccination-related headaches tend to resolve within a few days, whereas CVST symptoms could manifest over a week post-vaccination, and closer to a patient presenting to the emergency department with severe headache. No such rare events have been seen more than 3 weeks post-vaccination.

Dr Marks also said that this pause is a recommendation but does not prevent healthcare providers from providing the J&J vaccine to their patients should benefits of vaccination outweigh the risks.

“We’re not going to stop a provider from administering a vaccine,” he added. “The benefit/risk will be beneficial overall to that individual in a large majority of cases.”

Dr Marks said that while they don’t have a “definitive cause” for the adverse reactions, data from AstraZeneca on similar events in Europe, it is likely a “similar mechanism” with the J&J vaccine. An autoantibody against platelet factor 4 has recently been identified as the trigger for the reaction.
“The immune response occurs rarely after some people receive the vaccine, and that immune response leads to the activation of platelets and extremely rare blood clots,” he said.

However, Marks stopped short of calling it a “class effect,” meaning it was related to the viral vector vaccine itself. He said he wasn’t ready to make a “broad statement yet,” but “obviously it’s from the same general class of viral vectors.”

The AstraZeneca, J&J and Sputnik V vaccines all use adenovirus vectors to deliver antigens. The rate CVST for AstraZeneca was estimated by European officials to be about 5 per million doses. Though Sputnik V has no confirmed CVST cases, a recent report suggests a possibility.

Besides these, the Ebola vaccines are the only other ones to use adenovirus vectors.
Woodcock said that all US cases were in women of reproductive age, with one death and one hospitalisation, but Marks said it was not clear there was any association with hormonal contraception, which also carries a small thrombosis risk. The cases did not have any preexisting conditions which could have explained the events.

The American College of Obstetricians and Gynecologists (ACOG) noted there is no “clear phenotype” for women who may experience this complication.

“Until there is a better understanding of the frequency and impact of this finding, it will be important to encourage pregnant and postpartum women who wish to be vaccinated to receive the mRNA vaccines: Pfizer or Moderna,” said Christopher Zahn, MD, vice president for practice activities at ACOG, in a statement.

“If venous thrombosis is noted in the setting of thrombocytopenia, treatment includes intravenous immunoglobulin and other supportive care,” Dr Zahn added.

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 : COVIDTags :

SA to Expedite 80 000 Doses of J&J Vaccine

On By ModernMedia

South Africa will accelerate the rollout of the Johnson & Johnson vaccine, it has been reported.

SA has secured orders for 9 million doses of the vaccine, of which the first 80 000 are expected to arrive in the country next week. Since immunity with the Johnson & Johnson vaccine is achieved with a single dose, this will be enough for 9 million people in South Africa, barring some inevitable wastage. Results from clinical trials in South Africa show that the vaccine has an effectiveness of 57%, 28 days after vaccination.

Professor Linda-Gail Bekker at the Desmond Tutu HIV Centre, University of Cape Town, who was involved in a South African trial last year, explained that there is a delay between the results of a clinical trial and the licence being granted for commercial use. She has urged the need for rapid vaccine rollout, and had also tested positive for COVID herself along with her family during the festive season. As a stopgap measure, an interim vaccination plan with 80 000 doses will be put into action at 32 locations around the country.

Explaining the programme, Prof Bekker said: “Can we together bring this expedited plan forward so that we can make sure we, as quickly as possible, rollout phase one recipients – mainly healthcare workers – into a kind of emergency programme.”

Prof Bekker describes the expedited rollout as being different to a clinical trial.

She continued, “This is not clinical research in the clinical trial concept; it really is programme evaluation, and many eyes are on it at the moment to make sure that we have covered all aspects – ethical, safety and scientific. We will not move without those approvals.”

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