Tag: vaccine

Source: MyBroadband

Here are 10 steps before considering dismissing an employee for refusing to take the Covid-19 vaccine:

1. Perform a Covid-19 risk assessment

This will determine whether a mandatory vaccination policy is necessary and to identify employees who work in situations where:

  • The risk of transmission is high due to the nature of their work.
  • The risk for severe Covid-19 or death is high due to an employee’s age or comorbidities.

2. Develop a vaccination plan or adjust your existing Covid-19 plan

3. Educate employees about vaccines and provide them with more information

Relevant information can be found in the vaccine FAQ section of the NICD’s website .

4. Assist employees with registering for vaccination on the EVDS portal

Registering on the health department’s Electronic Vaccination Database System (EVDS) allow South Africans to book a time and select the vaccination site where they would like to receive their vaccine.

5. Give employees paid time off to be vaccinated

If you implement a mandatory vaccination policy, you may not withhold pay or force employees to take leave without pay.

6. Place employees who suffer from vaccine side effects on paid leave

Employees who suffer from side effects after taking the vaccine should be given sick leave. If their sick leave is exhausted, they may qualify for further paid time off.

7. Keep employees informed on vaccination issues

This includes notifying them about:

  • The obligation to be vaccinated and by what date.
  • The right to refuse to be vaccinated on constitutional or medical grounds.
  • The opportunity to consult with a health and safety representative, worker representative or trade union official.

8. Counsel employees who refuse to be vaccinated on any constitutional grounds

Talk to employees and allow them to seek guidance from a health and safety representative if requested. Refer the employee for further medical evaluation if they refuse to be vaccinated based on a medical condition.

9. Explore alternative arrangements

Dismissal should only be a last resort. The employer should attempt to accommodate the employee in a position where they do not require the vaccine.

Possible options to consider include letting the employee:

  • Work off-site
  • Work from home
  • Work in isolation (at the workplace)
  • Work outside normal working hours
  • Work while wearing an N95 mask

10. Follow the correct procedure for dismissals

If all other options have been exhausted, Truter advised against disciplinary action. Instead, he said to deal with the dismissal as one of “operational requirements” or “incapacity”.

Vaccines available for 18- to 34-year-olds

By Nicola Daniels for IOL

Vaccine registration is officially open to all adults, with the announcement that those aged 18 to 34-year-old will be eligible to register and get vaccinated from Friday onwards.

The announcement has been welcomed by Premier Alan Winde who said the province had the capacity to accommodate increased demand.

“I welcome, with excitement, the announcement today that residents in the 18 to 34-year-old age cohort (or 18+) will be eligible to register and get vaccinated from tomorrow onwards. This now means that all adult residents living in the Western Cape will have access to the lifesaving and job-creating vaccines,” Winde said.

He said there had been a decrease in vaccine uptake across the country, attributed to vaccine hesitancy and the need to improve access to vulnerable and remote groups.

“We’ve seen major interest and excitement from this age group, and we look forward to them making use of our vaccination sites. We have the capacity, infrastructure and supplies to manage this increased demand.”

So far, 741 356 vaccines have been administered to those in the over 60 age cohort, 309 587 vaccines have been administered to those in the over 50-59 age cohort and 372 782 vaccines have been administered to those in the over 35-49 age cohort.

Health head Dr Keith Cloete said there are currently 46 395 active infectious cases in the province, and the combined public-private oxygen utilisation is now 78.73 tons/day (104.9% of the maximal production capacity of 75 tons/day) at the Afrox Western Cape plant.

“We are in the peak of the third wave and are starting to see small percent decreases in some of our indicators. Case numbers have started to decrease. Admissions have plateaued with around 320 new admissions each day and deaths have decreased to around 100 deaths daily,” he said.

The numbers of children infected in this wave was also higher than any of the previous waves, he added.

“The risk of being exposed to Covid-19 at gatherings remains very high due to the high number of active cases,” said Cloete.

“Currently, there are 3663 Covid-19 patients in our acute hospitals, 2 003 in public hospitals and 1 660 in private hospitals. This excludes persons under investigation and cases in specialised hospital settings.”

Register by visiting: https://vaccine.enroll.health.gov.za/#/ or WhatsApp the word REGISTER to 0600 123456.


Vaccines and the workplace

By Kate Collier, Shane Johnson, Heather Mudau for Webber Wentzel

The Minister of Employment and Labour has issued a revised Covid-19 Direction on Health and Safety in the Workplace. The Direction was signed by the Minister on 28 May 2021. In line with the previous versions of this Direction, it applies to all workplaces except mines, ships, boats or cranes and any other workplace which is regulated by a different direction on health and safety.

The provisions in the previous Direction (gazetted on 1 October 2020) largely remain intact in this Direction. The latest amendments largely provide regulations relating to Covid-19 vaccines and guidelines for employers who are considering mandatory vaccination of their employees. We summarise the key clauses of the Direction for employers below.

Definition of “Covid-19 vaccines”
The Direction defines “Covid-19 vaccines” as:

“a vaccine that has been scientifically evaluated and recommended by the WHO and approved by the South African Health Products Regulatory Authority to be effective in preventing severe disease and death, and likely to reduce SARS-CoV-2 viral transmission in order to contribute to herd immunity”

Employers must ensure that they comply with the provisions of the Direction discussed below.

Administrative measures
The employer must take steps to generate awareness and educate employees on the Covid-19 vaccine, including information on the:

  • benefits of the vaccine
  • contra-indications for vaccination
  • nature and risk of any serious side-effects (eg severe allergic reactions)

To compile this information, the Direction refers employers to the Frequently Asked Questions section on the National Institute of Health website.

In addition to awareness and education around the Covid-19 vaccine, employers must also provide administrative support to employees to register on the Electronic Vaccine Data System Registration Portal for Covid-19.

Employers must also provide employees with paid time off to have the vaccination on the allocated date and time. The employee will be required to provide the employer with proof of vaccination, particularly when it is scheduled to take place during working hours.

Symptom screening
The Direction confirms that the isolation procedures applicable to employees who present with Covid-19 symptoms at work does not apply to employees who present with symptoms for one to three days after having the Covid-19 vaccination.

If an employee is unable to work after having had the Covid-19 vaccine due to side-effects, the employee should be placed on paid sick leave. The employer may accept a Covid-19 vaccination certificate as proof of illness instead of a medical certificate.

Employers who are considering mandatory vaccinations for employees must comply with the following provisions of the Direction.

Risk assessment and plans for protective measures
Clause 3(1)(ii) of the Direction provides that the employer must undertake a risk assessment within 21 days of the commencement of the direction to determine if it intends to make vaccination mandatory. If the employer does intend to make vaccination mandatory, it must then identify which employees must be vaccinated considering risk of transmission due to the nature of their work or risk of severe Covid-19 disease due to age or co-morbidities. Clause 3(3)(c) makes it clear that even if vaccination is mandatory, such a policy will only be enforceable “as and when Covid-19 vaccines become available”.

After conducting the risk assessment, the employer must clearly formulate a plan (or amend an existing plan) that outlines the measures it intends to implement on mandatory vaccination of employees.

The plan must include the following elements –

The identification of the employees who will be subject to vaccination

The process by which the obligations under the Direction will be complied with by the employer

Whether the employer is planning to make it mandatory for identified employees to be vaccinated
If the employer decides to make vaccination mandatory for employees, its mandatory vaccination policy must state that employees will be notified of the following:

  • the obligation to be vaccinated once the vaccine becomes available
  • their right to refuse to be vaccinated on constitutional or medical grounds
  • their opportunity to consult a health and safety representative, worker representative or trade union official

If an employee refuses to be vaccinated on any constitutional or medical grounds, the employer should take the following steps:

  • counsel the employee and, if requested, allow the employee to seek guidance from a health and safety representative, worker
  • representative or trade union official
  • refer the employee for further medical evaluation if there is a medical contraindication for vaccination
  • if necessary, take steps to reasonably accommodate the employee in a position that does not require the employee to be vaccinated.

Pfizer vaccine approved for emergency use

Source: Eyewitness News

The South African Health Products Regulatory Authority (SAHPRA) on Tuesday approved the Pfizer/BioNTech coronavirus vaccine for human use.

SAHPRA released a statement on its website on Tuesday afternoon, saying that the Section 21 application for the vaccine was approved. A Section 21 application is usually valid for six months and is used for emergency use access of a health product that is unregistered. AstraZeneca’s COVID-19 vaccine was granted Section 21 approval by SAHPRA in January.

This means that the vaccine can be distributed but will be conditional on its efficacy and safety, which will be continuously monitored.

SAHPRA is tasked with regulating all health products in the country and also oversees clinical trials.

South Africa has already ordered 20 million doses of the vaccine, which is yet to arrive. Its arrival date is still to be made clear.

The vaccine rollout to South Africans has not begun yet. The Johnson & Johnson vaccine currently being given to healthcare workers is part of the implementation study for that vaccine.


By Jamie McKane for MyBroadband

The government has launched its online vaccine registration platform for citizens, called the Electronic Vaccine Data System (EVDS).

Using this system, South Africans who qualify for phase 1 of the national vaccine rollout plan can register online for a COVID-19 vaccine using either their ID number or passport.

This system was announced by the Department of Health last week, with the department’s COO Milani Wolmarans explaining that the EVDS is linked to supply chain management to ensure that there are enough doses to inoculate the vaccines when they arrive at the local vaccination service site.

In order to get an appointment for a COVID-19 vaccination, users will have to register on this platform, which will be available on mobile devices and desktops.

Registering for a vaccination
In the first phase of the COVID-19 vaccine roll out only medical healthcare workers will be allowed to register, with the portal requiring users to enter their occupation, employer, whether they are patient-facing, and medical aid information before proceeding.

Those who qualify will be sent a notification through SMS informing them of the time and place that the vaccine will be available. It will also come with a unique code that patients will be required to show to their vaccinator.

The registration portal notes that registering online for a vaccine does not guarantee that you will receive one.

It also states that “eligibility of the vaccine will be determined by the National Department of Health based on priority population groups”.

The department added that information submitted through the vaccination portal will be used for the following:

  • Identifying eligible vaccination beneficiaries
  • Planning supply of vaccines and ancillary items
  • Allocating beneficiaries to their nearest available service point
  • Communicating with enrolled individuals about the vaccination programme
  • It is expected that the vaccine registration portal will be opened up to broader population groups once the national vaccine rollout plan has progressed

Currently, the national plan for COVID-19 vaccination comprises the following priority phases:

  • Phase 1: Frontline and healthcare workers.
  • Phase 2: Essential workers, institutionalised persons, and the elderly.
  • Phase 3: The remaining adult population.

South Africans who are eligible to receive a COVID-19 vaccine during phase 1 can register on the EVDS self-registration portal.

Pfizer leads vaccine race

Source: eNCA

A vaccine jointly developed by Pfizer and BioNTech was 90 percent effective in preventing COVID-19 infections in ongoing Phase 3 trials, the companies announced Monday.

Protection in patients was achieved seven days after the second of two doses, and 28 days after the first, according to preliminary findings.

“The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” Pfizer Chairman and CEO Albert Bourla said in a statement.

“We are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most,” Bourla added.

Across much of the globe, COVID-19 infections rates are soaring to record highs, with hospital intensive care units filling up and death tolls mounting as well.

Based on supply projections, the companies said they expect to supply up to 50-million vaccine doses globally in 2020, and up to 1.3-billion doses in 2021.


Local pharmaceutical company to produce vaccine

By Sandile Mchunu for IOL

Aspen Pharmacare Holdings added nearly R5 billion to its value yesterday after the South African pharmaceutical company said it had invested billions to manufacture the investigational Covid-19 vaccine with US giant Johnson & Johnson.

Aspen said its wholly-owned South African subsidiary, Aspen Pharmacare, had entered into a preliminary agreement with Janssen Pharmaceuticals Inc and Janssen Pharmaceutica NV – two of the Janssen Pharmaceutical companies of Johnson & Johnson – for the technical transfer and proposed commercial manufacture of their Covid-19 vaccine candidate, Ad26.CoV2-S.

The vaccine candidate is undergoing clinical trials at the existing sterile facility in Port Elizabeth.

Aspen chief executive Stephen Saad said the group planned to be a key part of the efforts to find a vaccine for a pandemic that had killed hundreds of thousands of people across the globe.

Saad said the group would utilise all its resources to provide assistance for patients in need across the world from their South African base.

“We have invested globally in our sterile capability and are determined to play a role in the manufacture of vaccines to add to our proud track record of making contributions to humanity in times of global pandemics,” Saad said.

“This has included, inter alia, being a leading global supplier for antiretrovirals for the treatment of HIV/Aids, multi-drug-resistant-TB products and Covid-19-related treatments, such as anaesthetics and dexamethasone. We have been selected as a vaccine partner by Johnson & Johnson, and this project will receive priority focus.”

Saad said Aspen would perform formulation, filling and secondary packaging of the vaccine for supply to Johnson & Johnson.

He said the agreement was, however, subject to the successful completion of the relevant technology transfer activities and finalisation of certain commercial manufacturing terms.

The group’s shares rose 11.45 percent to close at R117.64 on the JSE yesterday, pushing its market cap above the R50bn mark.

Michael Treherne, a portfolio manager at Vestact, said the share price movement was extraordinary for a group.

“The announcement is positive on two fronts. First, it is the potential for increased business, and second, it is a vote of confidence from one of the biggest pharma companies in the world. The way I understand it, Aspen has already spent R3bn on the facility, but it is also worth noting that an agreement has not been signed yet,” Treherne said.

In August, Aspen said its annual earnings were expected to increase as much as 11 percent.

The group said normalised headline earnings per share from continuing operations for the year to the end of June were likely to increase between 7 and 11 percent, to between 1 438.9 cents and 1 492.8c, from 1 344.8c last year.

It said normalised headline earnings per share was the primary measure used by management to assess Aspen’s underlying financial performance.

Yesterday, the group said it would provide the necessary capacity required for the manufacture of Johnson & Johnson’s Covid-19 vaccine candidate.

It said it had invested in excess of R3bn in the facility together with the high technology equipment and systems that would be used to manufacture state-of-the-art sterile drugs and vaccines, packaged into vials, ampoules and pre-filled syringes.

The group said the area where it is intended to develop the vaccine candidate would have capacity to produce more than 300 million doses a year.

Nesan Nair, a senior portfolio manager at Sasfin Securities, said the development boosted Aspen’s net worth.

“It is great news both for the fight against the Covid-19 pandemic and for Aspen … as well as for the fact that this vaccine will also be manufactured in South Africa,” Nair said.

Source: The Peninsula

South Africa will launch clinical trials of a US-developed coronavirus vaccine with 2,900 volunteers this week, the second such study in the African country worst hit by the disease, lead investigator Shabir Madhi said Tuesday.

Known as NVX-CoV2373, the vaccine was developed by US biotech company Novavax from the genetic sequence of SARS-CoV-2, the virus that causes the COVID-19 disease.

It will be administered to the first volunteer in the randomised, observer-blinded trial on Wednesday.

“It’s a two-dose schedule, and they get two either vaccines or placebos… spaced three weeks apart,” professor Madhi of the Johannesburg-based University of the Witwatersrand (Wits), told AFP.

With 589 886 cases and 11 982 deaths, South Africa is fifth in global rankings for countries with the most infections.

Since the country also accounts for 20 percent of global HIV infections according to UNAIDS 2020 data, 240 medically stable, HIV-positive adults will also participate in the clinical trial.

“It’s critical that we understand how these vaccines work in populations that have HIV, especially in South Africa where they constitute up to about 12 to 15 percent of the adult population,” said Madhi.

Wits University said studies of the Novavax vaccine in non-human primates have shown protection against the coronavirus infection in nasal passages as well as protection against lung disease.

Partly funded by a $15-million grant from the Bill & Melinda Gates Foundation, the trials are part of a larger study to be launched throughout the world to involve approximately 30,000 participants.

In June, South Africa piloted its first trial of a vaccine developed by the Britain-based Oxford Jenner Institute.

Some 2,000 people were injected with the vaccine known as ChAdOx1 nCoV-19 with 50 of the candidates having HIV.

Source: Reuters / IOL

President Vladimir Putin said on Tuesday that Russia had become the first country in the world to grant regulatory approval to a Covid-19 vaccine after less than two months of human testing, a move hailed by Moscow as evidence of its scientific prowess.

The development paves the way for the mass inoculation of the Russian population, even as the final stage of clinical trials to test safety and efficacy continue.

The speed at which Russia is moving to roll out its vaccine highlights its determination to win the global race for an effective product, but has stirred concerns that it may be putting national prestige before sound science and safety.

Speaking at a government meeting on state television, Putin said the vaccine, developed by Moscow’s Gamaleya Institute, was safe and that it had even been administered to one of his daughters.

“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” said Putin.

He said he hoped the country would soon start mass producing the vaccine.

Its approval by the health ministry foreshadows the start of a larger trial involving thousands of participants, commonly known as a Phase III trial.

Such trials, which require a certain rate of participants catching the virus to observe the vaccine’s effect, are normally considered essential precursors for a vaccine to receive regulatory approval.

Regulators around the world have insisted that the rush to develop Covid-19 vaccines will not compromise safety. But recent surveys show growing public distrust in governments’ efforts to rapidly produce such a vaccine.

Russian health workers treating Covid-19 patients will be offered the chance of volunteering to be vaccinated soon after the vaccine’s approval, a source told Reuters last month.

More than 100 possible vaccines are being developed around the world to try to stop the Covid-19 pandemic. At least four are in final Phase III human trials, according to WHO data.

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