Tag: Covid Vaccine

 COVID-19 Vaccination  during Pregnancy; CDC data


Safety and Effectiveness of COVID-19 Vaccination during Pregnancy-

CDC released the first U.S. data on the safety of receiving an mRNA COVID-19 vaccine during pregnancy.

Evidence about the safety and effectiveness of COVID-19 vaccination during pregnancy, although limited, has been growing. These data suggest that the benefits of receiving a COVID-19 vaccine outweigh any known or potential risks of vaccination during pregnancy.

  • No safety concerns were found in animal studies: Studies in animals receiving a Moderna, Pfizer-BioNTech, or Johnson & Johnson (J&J)/Janssen COVID-19 vaccine before or during pregnancy found no safety concerns in pregnant animals or their babies.
  • No adverse pregnancy-related outcomes occurred in previous clinical trials that used the same vaccine platform as the J&J/Janssen COVID-19 vaccine: Vaccines that use the same viral vector have been given to pregnant people in all trimesters of pregnancy, including in a large-scale Ebola vaccination trial. No adverse pregnancy-related outcomes, including adverse outcomes affecting the baby, were associated with vaccination in these trials. Learn more about how viral vector vaccines work.

  • COVID-19 vaccines do not cause infection, including in pregnant people or their babies: None of the COVID-19 vaccines contain the live virus that causes COVID-19 so a COVID-19 vaccine cannot make anyone sick with COVID-19, including pregnant people or their babies.
  • Early data on the safety of receiving an mRNA COVID-19 vaccine (Moderna or Pfizer-BioNTech) during pregnancy are reassuring:
    • CDC released the first U.S. data on the safety of receiving an mRNA COVID-19 vaccine during pregnancy. The report analyzed data from three safety monitoring systems in place to gather information about COVID-19 vaccination during pregnancy. These early data did not find any safety concerns for pregnant people who were vaccinated or their babies.1
    • Another report looked at pregnant people enrolled in the v-safe pregnancy registry who were vaccinated before 20 weeks of pregnancy. Scientists did not find an increased risk for miscarriage among people who received an mRNA COVID-19 vaccine during pregnancy.2
    • Many pregnancies reported in these safety monitoring systems are ongoing. CDC will continue to follow people vaccinated during all trimesters of pregnancy to better understand effects on pregnancy and babies.
  • Early data suggest receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for infection: A recent study from Israel compared pregnant people who received an mRNA COVID-19 vaccine with those who did not. Scientists found that vaccination lowered the risk of infection from the virus that causes COVID-19.3
  • Vaccination of pregnant people builds antibodies that might protect their baby: When pregnant people receive an mRNA COVID-19 vaccine during pregnancy, their bodies build antibodies against COVID-19, similar to non-pregnant people. Antibodies made after a pregnant person received an mRNA COVID-19 vaccine were found in umbilical cord blood. This means COVID-19 vaccination during pregnancy might help protect babies against COVID-19. More data are needed to determine how these antibodies, similar to those produced with other vaccines, may provide protection to the baby.4

Additional clinical trials that study the safety of COVID-19 vaccines and how well they work in pregnant people are underway or planned. Vaccine manufacturers are also collecting and reviewing data from people in the completed clinical trials who received a vaccine and became pregnant.

Vaccine Side Effects

Side effects can occur after receiving any of the available COVID-19 vaccines, especially after the second dose for vaccines that require two doses. Pregnant people have not reported different side effects from non-pregnant people after vaccination with mRNA COVID-19 vaccines (Moderna and Pfizer-BioNTech vaccines). If you experience fever following vaccination you should take acetaminophen (Tylenol®) because fever—for any reason—has been associated with adverse pregnancy outcomes. Learn more at What to Expect after Getting a COVID-19 Vaccine.

Although rare, some people have had allergic reactions after receiving a COVID-19 vaccine. Talk with your healthcare provider if you have a history of allergic reaction to any other vaccine or injectable therapy (intramuscular, intravenous, or subcutaneous).

Key considerations you can discuss with your healthcare provider include:

  • The unknown risks of developing a severe allergic reaction
  • The benefits of vaccination

If you have an allergic reaction after receiving a COVID-19 vaccine during pregnancy, you can receive treatment for it.

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3

Challenges of Covid Vaccination-2021


If 2020 was consumed by Covid Virus ,  the next year 2021 will be  for Covid vaccination.

All over the world, billions of people are going to get vaccine.

Corona vaccination is one of the most anticipated events in every country. in coming weeks, multiple vaccines   are likely to get regulatory approval. 

    However, while making a good vaccine was the difficult part, earning  trust of public in vaccine is going to be another one. Especially the hurried development at Pandemic speed  and lack of awareness about safety issues will be areas of concern.

  The adverse events, which are unexpected medial problems that occur with drug treatments, are unavoidable part of any treatment, including vaccine science.

    The system need to be in place to identify  the causal relationship between vaccine agent and  the adverse event.  The objective criteria have to be in place to identify and treat, as the population to be vaccinated is also very large.

 The main hurdles equally challenging will be sourcing, distributing and giving the actual vaccination doses.

The preparation for mammoth exercise will also be a herculean task. It may take months to get ready to supply and build the chains and preparation for this need to begin now.

A systematic approach needs to be ready, so that the process of vaccination gets on smoothly and quickly, as soon as the doses are available. For example, the need for transport vehicles and the storage facilities for billions of doses at distant places will be one of challenges.

It will take mammoth number of healthcare workers, who will vaccinate people at different towns and cities.  

This exercise, if not done in a well-planned manner, could result in chaos.   The failure to set up a system will not only result in suboptimal vaccination but also non uniform supplies. Maintaining the cold chain will be crucial for effectiveness.

 People should get it based on needs rather than black marketing or money power.   The issues which look insignificant like the financial complexity among various stake holders or customer clearances need to be settled first, as they may become significant hurdles for smooth distribution.

    Most important would be to safeguard citizen’s faith in vaccine and clinical trials. As for the future science to develop, would   require people’s co-operation, faith and participation.

     Government regulators and Vaccine makers need to recognize the utmost importance of the communication about the true results of trials and effective communication with the public.  The misinformation and distrust should not  undermine the good work of medical science and advancements.

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Authorities mum on Adverse Event at Covid Vaccine Trial


Safety data of Covid Vaccine- need disclosure

   There are two important aspect of a successful vaccine,

1. Efficacy  for the prevention

2. Safety

       Given that the Covid vaccine is needed urgently and will be developed within a years’ time, some doubts about the safety aspect are natural. But safety can be assured, if the data about side effects is made public.

   All  the  companies  in a bid to rush their  vaccine into the market, are eager to  create an hype. But a caution need to be exercised against such hyping, especially when long term safety data is not available.

  Even the sparse details of the severe side effect,  that leak into the public domain, may be just tip of the iceberg, as far as long term safety data of a vaccine is concerned.

   All the side effects, mild or severe, need to be made known  and  in public domain, rather than exposed later after the use.

More than a month and a half after an adverse event occurred in a clinical trial in India of the AstraZeneca vaccine, the Central Drug Standard Control Organisation (CDSCO), the regulator for vaccine trials, has not issued any statement on the occurrence. It also did not respond to queries about whether it has completed its investigation to determine if the trial participant’s illness was related to the vaccine. Serum Institute, which is partnering the pharma MNC and Oxford University for producing the vaccine in India, has also refused to comment. This is in sharp contrast to AstraZeneca and Oxford University going public when one of the trial participants in the vaccine trial in the UK fell ill and halting the trial till an independent safety monitoring board and UK’s regulatory authority gave safety clearance. Information about the occurrence of the serious adverse event (SAE) during the vaccine trial in India came from the family of the trial participant, which has sent the company and the regulators a legal notice. Serum Institute merely stated that it would issue an official statement next week. AstraZeneca had issued a statement within days of the trial participant in UK falling ill and halted the trials across the world in the UK, Brazil and South Africa. The trial was resumed within a week after the independent safety review committee and national regulators gave clearance. The Indian Council of Medical Research is a co-sponsor of the trial along with Serum Institute.

According to the ICMR, it is for the DCGI to take a call on whether or not to halt the trial. The DCGI heads the CDSCO.

The 40-year-old trial participant, a business consultant with an MBA from New Zealand who says he took part in the trial deeming it his duty to help such an important venture, was administered the vaccine at SRMC on October 1. Eleven days later, he woke up with a severe headache, and progressively lost his memory, showed behaviour changes, became disoriented and was unable to talk or recognise his family members, according to the legal notice. As soon as he fell ill he was admitted to the ICU in SRMC.

“Though the legal notice we have served talks of a compensation of Rs 5 crore, our focus is not on monetary compensation. It was sent just last week, more than a month after the occurrence when we saw that none of the authorities was making the adverse event public. They ought to have warned other participants so that they could watch out for similar symptoms. We want to know why the occurrence of the adverse event has been kept under wraps and why the trial was not halted like it was done in the UK. Is an Indian life of less value than that of an UK citizen?” asked a close family friend who has been helping the family cope with the illness.

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Potential Ray of Hope: Highly effective coronavirus antibodies


        Identification of highly effective antibodies, will not only provide a passive immunity, but can be helpful in developing vaccine as well. This discovery may be a potential ray of hope against Covid war.

Highly effective coronavirus antibodies discovered may lead to passive Covid-19 vaccine

     BERLIN: Scientists have identified highly effective antibodies against the novel coronavirus, which they say can lead to the development of a passive vaccination for Covid-19. Unlike in active vaccination, passive vaccination involves the administration of ready-made antibodies, which are degraded after some time. However, the effect of a passive vaccination is almost immediate, whereas with an active vaccination it has to build up first, the researchers said. The research, published in the journal Cell, also shows that some SARSCoV-2 antibodies bind to tissue samples from various organs, which could potentially trigger undesired side effects. The scientists at the German Center for Neurodegenerative Diseases (DZNE) and Charite – Universitatsmedizin Berlin isolated almost 600 different antibodies from the blood of individuals who had overcome Covid-19, the disease triggered by SARS-CoV2. By means of laboratory tests, they were able to narrow this number down to a few antibodies that were particularly effective at binding to the virus.  Highly effective coronavirus antibodies identified, may lead to passive Covid-19 vaccine The researchers then produced these antibodies artificially using cell cultures. The so-called neutralising antibodies bind to the virus, as crystallographic analysis reveals, and thus prevent the pathogen from entering cells and reproducing, they said. In addition, virus recognition by antibodies helps immune cells to eliminate the pathogen. Studies in hamsters — which, like humans, are susceptible to infection by SARS-CoV-2 — confirmed the high efficacy of the selected antibodies. “If the antibodies were given after an infection, the hamsters developed mild disease symptoms at most. If the antibodies were applied preventively — before infection — the animals did not get sick,” said Jakob Kreye, coordinator of the research project. The researchers noted that treating infectious diseases with antibodies has a long history. For Covid-19, this approach is also being investigated through the administration of plasma derived from the blood of recovered patients. With the plasma, antibodies of donors are transferred, they said. “Ideally, the most effective antibody is produced in a controlled manner on an industrial scale and in constant quality. This is the goal we are pursuing,” said Momsen Reincke, first author of the research. “Three of our antibodies are particularly promising for clinical development,” explained Harald Pruss, a research group leader at the DZNE and also a senior physician at Charite – Universitatsmedizin Berlin. “Using these antibodies, we have started to develop a passive vaccination against SARS-CoV-2,” Pruss said. In addition to the treatment of patients, preventive protection of healthy individuals who have had contact with infected persons is also a potential application, the researchers said. How long the protection lasts will have to be investigated in clinical studies, they said. “This is because, unlike in active vaccination, passive vaccination involves the administration of ready-made antibodies, which are degraded after some time,” Pruss said. In general, the protection provided by a passive vaccination is less persistent than that provided by an active vaccination, the researchers said. “It would be best if both options were available so that a flexible response could be made depending on the situation,” Pruss added.

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